logging in or signing up Organization and peronnel GMP nishit_patel5 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: Embed: Flash iPad Dynamic Copy Does not support media & animations Automatically changes to Flash or non-Flash embed WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 648 Category: Science & Tech.. License: All Rights Reserved Like it (0) Dislike it (0) Added: December 08, 2011 This Presentation is Public Favorites: 1 Presentation Description No description available. Comments Posting comment... By: shradhanjalising (9 month(s) ago) dear friend nice ppt on UV visible instrumentation. Could you plz send this ppt on singhshradhanjali@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: dlingam6 (10 month(s) ago) ver good Saving..... Post Reply Close Saving..... Edit Comment Close By: sumalathaglory (14 month(s) ago) Hi, this ppt was really informative can you please send the ppt of LCMS to my glory.sumalatha@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: kasturi1995 (15 month(s) ago) ongrets its very best ppt please send me on my email madhuripbhise@gmail.com Thankin You Saving..... Post Reply Close Saving..... Edit Comment Close By: vhbhaskar (16 month(s) ago) Dear friend,Its nice Ppt. regarding IND and NDA.. Please send me on my email rajgornaresh@gmail.com. Havee a nice day Saving..... Post Reply Close Saving..... Edit Comment Close loading.... See all Premium member Presentation Transcript PowerPoint Presentation: Prepared by: Guided by: Dipali S. Patel Dr. Nehal J. Shah M.Pharm (Q.A.) Principal 1 st Semester DDPC Dharmaj Degree Pharmacy College 1PowerPoint Presentation: 2 RESPONSIBILITIES OF QUALITY CONTROL UNIT: (1) (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, and the authority to review production records to assure that no errors have occurred, or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company. (b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, inprocess materials, and drug products shall be available to the quality control unit.PowerPoint Presentation: 3 c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. (d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed. The regulations clearly assign to the quality control (QC) unit responsibility for approval or rejection of components, in-process materials, and products.PowerPoint Presentation: 4 The CGMPs focus all responsibility for quality onto the QC unit. There are no defined responsibilities for production management—unlike the European and World Health Organization (WHO) guidelines, which define both separate and joint responsibilities for these functions. This latter approach more clearly emphasizes that the consistent achievement of quality standards requires a team effort. A more effective approach has been to design quality into products during the development phase and then to build in additional assurance during production.PowerPoint Presentation: 5 Within the production operations all quality-impacting procedures and systems are to be approved by QC. Typically, these include such procedures as standard operating procedures (SOPs), process validation protocols, supplier certification protocols, complaint handling, process control procedures, and even design of buildings. QC has effective procedures to ensure that such systems are reviewed in a timely manner and that changes cannot be introduced without approval. During 1985 and 1986 several companies had serious problems associated with changes in formulations and manufacturing processes, which then failed to comply with requirements of NDA and ANDA documentation. These discrepancies resulted in halting of distribution and recalls, with significant loss of revenue to the companies involved.PowerPoint Presentation: 6 QC is also responsible for approving or rejecting labeling. This responsibility lies in two areas. First, new or modified labeling should be reviewed to ensure that it complies with the ANDA, NDA, OTC monograph, or other official requirements. This checking may be delegated to other functions, but QC must assure that the checkers are qualified to perform their function and that they have done so. Second, incoming labeling supplies are to be evaluated to assure they are correct. These responsibilities do not apply to promotional literature.PowerPoint Presentation: 7 The regulations require adequate laboratory facilities to be available to the QC unit. This clearly allows use of outside laboratories where necessary, but these should be comprehensively evaluated before use. The approval/rejection responsibility also applies to operations contracted out to other companies. This does not necessarily require any additional or duplicate testing. The regulations essentially expect the QC/QA function to provide an independent policy-type role, to monitor the entire production process from purchasing of materials to distribution and use of the product.PowerPoint Presentation: 8 The FDA emphasis for QC is on release and/or rejection authority. These include creation of quality awareness, involvement in product design and development, design and provision of quality training, facilitation for quality improvement, analysis of quality trend data to identify improvement needs and opportunities, identification of quality metrics, and collection and dissemination of quality benchmarking data. These additional activities all enhance the awareness and involvement of senior management, thereby assuring greater emphasis and attention to quality by all functions. With the increased reliance on non-QC personnel for quality-related activities, such as in-process control and customer complaint coordination, the role of the quality assurance (QA) unit has become critical.PowerPoint Presentation: 9 QC should be a resource that plays a positive role in improving profitability. Some companies have gone a step further by insisting that the QC unit should report outside of the plant operations to a group QC function or other scientific or technical function. This arrangement certainly provides an added level of independence and appears to be favored by the FDA. With a totally independent QC unit, there is likely to be a chance of divided responsibility—production to produce and QC to confirm quality.PowerPoint Presentation: 10 Figure 1: Typical plant organization. (1)PowerPoint Presentation: 11 It is preferable that the entire plant operate as a quality-aware team, every individual being expected to perform his or her job in such a manner as to achieve the quality standards. QC then becomes a supporting resource. This is more likely to occur if the QC unit reports directly to the leader of the plant team—the plant manager. An adequate degree of independence can be incorporated into the organization by having a clearly defined functional reporting (‘‘dotted line’’) relationship to a suitable scientific professional in the organization (Figure 1). This approach encourages a team spirit, which will result in a higher and more consistent achievement of quality standards.PowerPoint Presentation: 12 PERSONNEL QUALIFICATIONS AND TRAINING: (1) (a ) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions. Training in current good manufacturing practice (cGMP) shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them.PowerPoint Presentation: 13 b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. (c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.PowerPoint Presentation: 14 The development and training of employees, at all levels, should be seen as a continuous process (Figure 2) in which performance appraisal plays a key role. The GMP regulations do not attempt to define the education, knowledge, skills, or experience required for the different types of job within a pharmaceutical company. This is significantly different from the European and WHO guidelines, which do specify the knowledge and experience requirements for those individuals designated as responsible for production and quality. The consistent achievement of quality standards requires understanding of, and compliance with, established procedures.PowerPoint Presentation: 15 Consequently, initial screening should select only those individuals who have such basic skills as reading, writing, and numeracy. An employee who cannot understand written instructions will find it difficult to follow procedures; an inability to write coherently will inhibit the recording of atypical situations, while a lack of numeracy could make it impossible to perform certain in-process testing such as statistical process controls.PowerPoint Presentation: 16 Figure 2: Training and development cycle. (1)PowerPoint Presentation: 17 In addition to these basic skills required by every employee, there are specific requirements for certain jobs, such as higher qualifications in engineering, chemistry, microbiology, etc. In order to define these additional requirements it is important to perform a knowledge and skills assessment for each job category. Because of the changing environment in which we work it is essential to reevaluate these needs from time to time. Preemployment screening for the purpose of identifying potential security risks is of special importance when the pharmaceutical manufacture involves the handling of controlled substances.PowerPoint Presentation: 18 This screening must not only include careful scrutiny of the potential employee’s personal and previous employment references, but also whatever review of criminal background as may be possible. Once accepted for employment, the initial, or induction, training takes place. This usually occurs on the first day and includes background on the industry, the company—its policies and procedures—and some fundamentals on the importance of the employee’s role to the health and well-being of the ultimate consumer.PowerPoint Presentation: 19 This session tends to be somewhat general in nature and should be followed by the more specific basic training. Basic training will usually take place over a period of time during which the new employee will be closely supervised. During this stage the employee must be fully trained in all relevant techniques associated with the equipment involved and fully understand the procedures to be followed, and must be aware of the potential problems that can be created by nonadherence to these procedures.PowerPoint Presentation: 20 Training programs must include appropriate evaluation steps. These will usually involve some type of evaluation at the end of each module followed by on-the-job appraisal to confirm that the lessons learned have been put into practice. Repeat training should be initiated when necessary. Personnel working in areas where contamination is hazard, e.g., clean areas or areas where highly active, toxic, infectious, or sensitizing materials are handled, should be given specific training. (2)PowerPoint Presentation: 21 Visitors or untrained personnel should preferably not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, practically about personnel hygiene and the prescribed protective clothing. They should be closely supervised. (2) Education and training records must be maintained and kept current; FDA inspectors may ask for confirmation of adequate training. The responsibility for training of employees should reside with departmental management. However, the QC department should monitor or audit to ensure that the appropriate training has been given. This could include review of training module content and also of training records.PowerPoint Presentation: 22 PERSONNEL RESPONSIBILITIES: (1,2,3) (a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. (b) Personnel shall practice good sanitation and health habits. (c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.PowerPoint Presentation: 23 (d) Any person shown at any time (either by medical examination or by supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.PowerPoint Presentation: 24 The use of plant uniforms is generally a more satisfactory way of maintaining adequate standards of dress and the following guidelines may be applied: 1. A sufficient amount of clean uniforms is provided so that changes can be made at an adequate defined frequency or whenever they became soiled. 2. Washing and sanitation procedures should be checked to confirm their effectiveness. 3. Employees in special clean areas should wear only lint-free garments to prevent shedding. 4. Garments should be designed and use material that maximizes personal comfort.PowerPoint Presentation: 25 5. The range of clothing available would normally include: a. Hats or hair cover b. Beard and moustache covers c. Coveralls—preferably with no pockets, or pockets suitably designed to prevent articles falling out d. Disposable gloves e. Foot covers or shoes f. Masks g. Safety glasses or goggles h. Appropriate clean-room suits for sterile areasPowerPoint Presentation: 26 6. Employees should be shown how and when to wear the appropriate clothing. 7. Work clothing should not be worn outside of the appropriate plant area, and changing rooms should be available. The continued wearing of such clothing in cafeteria areas during breaks should also be evaluated. Food particles in and on clothing can introduce bacterial, fungal, and yeast contamination. Obviously, operators in sterile areas will change prior to leaving the area, and this may be desirable for some other areas, especially to minimize the potential for cross-contamination.PowerPoint Presentation: 27 Preemployment medical examination (include some medical history, chest x-ray, Wassermann test, and tuberculosis test) and Annual medical reexaminations are required. Ideally, these employees should be allowed to work at tasks in which they cannot contaminate products and at their usual rate of pay. The primary objective of this section of the regulations is to protect the product from potential contamination from personnel—particulate matter including hair, fibers, and outside ‘‘dirt,’’ cross-contamination carried on clothing from other processes, microorganisms shed from skin and from the mouth and nose.PowerPoint Presentation: 28 The head of production and quality control departments generally have some shared, or jointly exercised , responsibilities relating to quality. (2) which include, The authorization of written procedures and other document including amendments. The monitoring and control of manufacturing environment. Plant hygiene Process validation and calibration of analytical apparatus. The approval and monitoring of suppliers of materials.PowerPoint Presentation: 29 The approval and monitoring of contract manufacturers. The designation and monitoring of storage conditions for materials and products. The retention of records. Monitoring of compliance with GMP requirements. The inspection, investigation and taking of samples, in order to monitor the factors that may affect product quality.PowerPoint Presentation: 30 The head of the production department generally has the following responsibilities. (2) To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. To approve the instruction relating to production operations, including the in-process controls, and to ensure their strict implementation. To ensure that the product records are evaluated and signed by a designated person before they are made available to the QC-department.PowerPoint Presentation: 31 To check the maintenance of the department, premises, and equipment. To ensure that the appropriate process validations and calibrations of control equipments are performed and recorded and the records are made available. To ensure that the required initial and continuing training of production personnel is carried out and adapted according o need.PowerPoint Presentation: 32 The head of quality control department generally has the following responsibilities , (2) To approve pr reject the starting materials, packaging materials and intermediate, bulk and finished products. To evaluate batch records. To ensure that all necessary testing is carried out. To approve sampling instructions, specifications, test methods and other quality control procedures.PowerPoint Presentation: 33 To approve and monitor analyses carried out under contract. To check the maintenance of the department, premises and equipments. To ensure that the appropriate validation including those of analytical procedures, and calibrations of control equipments are done. To ensure that the required initial and continuing training of quality control personnel is carried out and adapted according to need.PowerPoint Presentation: 34 Testing facility management’s (TFM’s) responsibility: (according to GLP) (3) Designate a study director before study is initiated. Replace the study director promptly if it becomes necessary to do so during the conduct of the study. Assure that there is a quality assurance unit. Assure that the test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.PowerPoint Presentation: 35 Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled. Assure that personnel clearly understand the functions they are to perform. Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.PowerPoint Presentation: 36 Study director’s responsibility: (according to GLP) (3) The protocol, including any change, is approved as provided and is followed. The study director does not approve the protocol but only makes certain that approval is obtained from sponsor management. All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.PowerPoint Presentation: 37 d) Test systems are as specified in the protocol. e) All applicable GLP regulations are followed. f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.PowerPoint Presentation: 38 Responsibility of Quality Assurance unit: (according to GLP) (3) A testing facility shall have a QA unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, and controls are in conformance with the regulations in this part. The QA unit shall: Maintain a copy of master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test articles and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.PowerPoint Presentation: 39 Maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible. Inspect all nonclinical laboratory study at interval adequate to assure the integrity o study and maintain written and properly signed records of each periodic inspection. Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.PowerPoint Presentation: 40 Determine that no deviations from approved protocols or SOPs were made without proper authorization ad documentation. Review the final study report to assure that such report accurately describes the methods and SOPs. Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.PowerPoint Presentation: 41 The responsibilities and procedures applicable to the QA unit and the method of indexing such records shall be in writing and shall be maintained. A designated representative of the FDA shall have access to the written procedures established for the inspections and may request testing facility management to certify that inspections are being implemented, performed, documented and followed-up accordingly.PowerPoint Presentation: 42 Responsibility of Quality Assurance unit: (2) Ensure feasibility of new projects or products for customer specifications. Availability of specifications based on customer requirements. Approval of procedures/methods, processes, specifications and other relevant documents. Availability of adequate resources and facilities and procedures for scale up studies, stability of new products. Authorization before final transfer of information to QA and production. To ensure that all personnel are adequately trained and arrange for continuing training whenever necessaryPowerPoint Presentation: 43 Functions of Personnel Management : (4) Recruitment of personnel Placement of labour force Providing training tro those who need such a training for improving their efficiency and skill Improving the job performance Soliciting creative cooperation from the labour force Developing better coordination and good cordial industrial relations Providing explanation and interpretation of the policies and procedure of the organization h) Controlling labour cost creating soothing work atmosphere.PowerPoint Presentation: 44 PERSONNEL HYGIENE: (2) All personnel, prior and or during employment should undergo health examinations. Personnel conducting visual inspection should also undergo periodic eye examinations. All personnel should be trained in the practices of personnel hygiene. A high level of personnel hygiene should be observed by all those concerned with manufacturing process. In particular, personnel should be instructed to wash their hands before entering the manufacturing areas.PowerPoint Presentation: 45 Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study shall be excluded from direct contact with test systems and any other operation or function that may adversely affect the study until the condition is corrected. All employees should be instructed and encouraged to report to their immediate supervisor any conditions (relating to plant, equipment or personnel) that may adversely affect the products. Direct contact should be avoided between the operator’s hand and staring materials, primary packaging materials, and intermediate or bulk product.PowerPoint Presentation: 46 To ensure protection of the product from contamination, personnel should wear clean body covering appropriate to the duties they perform, including appropriate hair covering. Used clothes should be stored in separate closed containers until properly laundered and, if necessary, disinfected or sterilized. Smoking, eating, drinking, chewing and keeping plants, food, drink, smoking material, and personnel medicines should not be permitted in production, laboratory and storage areas or in any other areas were they might adversely influence product quality. Personnel hygiene procedures including the use of protective clothings should apply to all persons entering production areas, where they are temporary or fulltime employees or non-employees. E.g., containers’ employees, visitors, senior manager and inspectors.PowerPoint Presentation: 47 PERSONNEL RECORDS : (5) All the records must be maintained and kept current; FDA inspectors may ask for it anytime. They must be in proper format. They must be retained for a specific time period.PowerPoint Presentation: 48 Record Statutory retention period Statutory authority accident books, accident records/reports 3 years after the date of the last entry The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) Manufacturing records At least 5 years from date of manufacture Drug and cosmetic act-1940 accounting records 3 years for private & 6 years for public limited companies Section 221 of the Companies Act 1985PowerPoint Presentation: 49 income tax and NI returns, income tax records not less than 3 years after the end of the financial year to which they relate The Income Tax (Employments) Regulations 1993 medical records 40 years from the date of the last entry The Control of Lead at Work Regulations 1998 medical records under the Ionising Radiations Regulations 1999 until the person reaches 75 years of age, but in any event for at least 50 years The Ionising Radiations Regulations 1999PowerPoint Presentation: 50 records of tests and examinations of control systems and protective 5 years from the date on which the tests were carried out The Control of Substances Hazardous to Health Regulations 1999 (COSHH) records relating to children until the child reaches the age of 21 Limitation Act 1980 wage/salary records (also overtime, bonuses, expenses) 6 years Taxes Management Act 1970PowerPoint Presentation: 51 Comparison of FDA, EPA, OECD-GLP principles with respect to Organization & Personnel:PowerPoint Presentation: 52 Topic FDA EPA OECD-GLP Training & Experience of Personnel (a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions. (a) Each individual engaged in the conduct of or responsible for the supervision of a study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions. (a)All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good Laboratory Practice which are applicable to their involvement in the study.PowerPoint Presentation: 53 Summary of Training & Job Descriptions (b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study. (b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a study. (b) ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;PowerPoint Presentation: 54 Sufficient Personnel (c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol. (c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol. (c) ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study;PowerPoint Presentation: 55 Personnel Health Precautions (d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems. (d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test, control, and reference substances and test systems. (d) Study personnel should exercise health precautions to minimize risk to themselves and to ensure the integrity of the study.PowerPoint Presentation: 56 Clothing for Personnel (e) Personnel engaged in a nonclinical laboratory study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test and control articles. (e) Personnel engaged in a study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test, control, and reference substances.PowerPoint Presentation: 57 Personnel Illness Precautions (f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study shall be excluded from direct contact with test systems and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors. (f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the study shall be excluded from direct contact with test systems, test, control, and reference substances and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a study. (f) They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.PowerPoint Presentation: 58 TFM - Assure Appropriate Testing (a) Assure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. (a) Assure that test, control, and reference substances or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. (a) ensure that test and reference items are appropriately characterized;PowerPoint Presentation: 59 TFM- Assure Availability of Resources (b) Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled. (b) Assure that personnel, resources, facilities, equipment, materials and methodologies are available as scheduled. (b) ensure that test facility supplies meet requirements appropriate to their use in a study;PowerPoint Presentation: 60 TFM - Assure Corrective Actions (c) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented. (c) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.PowerPoint Presentation: 61 General Responsibilities of a Study Director (a) For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. (a) For each study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control. (a) The Study Director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.PowerPoint Presentation: 62 Study Director - Recording & Verification of Data (b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. (b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. (b) ensure that all raw data generated are fully documented and recorded;PowerPoint Presentation: 63 Study Director - GLP Compliance (c) All applicable good laboratory practice regulations are followed. (c) All applicable good laboratory practice regulations are followed. (c) sign and date the final report to indicate acceptance of responsibility for the validity of data and to indicate extent to which the study complies with these Principles of GLP;PowerPoint Presentation: 64 Study Director - Archiving (d) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study. (d) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study. (d) Ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.PowerPoint Presentation: 65 QAU General Responsibilities (a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. (a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. The quality assurance unit shall conduct inspections and maintain records appropriate to the study. 1) The test facility should have a documented Quality Assurance Programme to assure that studies performed are in compliance with these Principles of Good Laboratory Practice. 2) The Quality Assurance Programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.PowerPoint Presentation: 66 QAU Independence (a) For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. (a) For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. This individual(s) should not be involved in the conduct of the study being assured.PowerPoint Presentation: 67 QAU - Maintain Copy of Master Schedule (1) Maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director. (1) Maintain a copy of a master schedule sheet of all studies conducted at the testing facility indexed by test substance and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director. (a) have access to an up-to-date copy of the master schedule;PowerPoint Presentation: 68 QAU - Maintain Copies of Protocols (2) Maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible. (2) Maintain copies of all protocols pertaining to all studies for which the unit is responsible. (a) maintain copies of all approved study plans and Standard Operating Procedures in use in the test facilityPowerPoint Presentation: 69 QAU - Inspections (3) Inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection. (3) Inspect each study at intervals adequate to ensure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for re-inspection. (c) Conduct inspections to determine if all studies are conducted in accordance with these Principles of Good Laboratory Practice. Inspections should also determine that study plans and Standard Operating Procedures have been made available to study personnel and are being followed. Inspections can be of three types as specified by Quality Assurance Programme Standard Operating Procedures: Study-based inspections, Facility-based inspections, Process-based inspections. Records of such inspections should be retained.PowerPoint Presentation: 70 QAU - Reporting 1) Any problems found during the course of an inspection which are likely to affect study integrity shall be brought to the attention of the study director and management immediately. 2) Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken. 1) Any problems which are likely to affect study integrity found during the course of an inspection shall be brought to the attention of the study director and management immediately. 2) Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken. 1) promptly report any inspection results in writing to management and to the Study Director, and to the Principal Investigator(s) and the respective management, when applicable;PowerPoint Presentation: 71 QAU - Assure Deviations are Authorized (3) Determine that no deviations from approved protocols or SOPs were made without proper authorization and documentation. (3) Determine that no deviations from approved protocols or SOPs were made without proper authorization and documentation.PowerPoint Presentation: 72 QAU - Review of Final Report (4) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study. (4) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study. (4) inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies;PowerPoint Presentation: 73 QAU - Final Report Statement (5) Prepare and sign a statement to be included with the final study report which shall specify the date’s inspections were made and findings reported to management and to the study director. (5) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director. (5) prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the Study Director and Principal Investigator(s), This statement would also serve to confirm that final report reflects the raw data.PowerPoint Presentation: 74 QAU - Responsibilities & Procedures (6) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees of the Food and Drug Administration. (6) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees or duly designated representatives of EPA or FDA.PowerPoint Presentation: 75 QAU - Management Certification of QAU Inspections (7) A designated representative of the Food and Drug Administration shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed-up in accordance with this paragraph. (7) An authorized employee or a duly designated representative of EPA or FDA shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed up in accordance with this paragraph.PowerPoint Presentation: 76 References: Good Manufacturing Practice for Pharmaceuticals; Sidney H. Willig, James R. Stoker; Marcell Dekker, Inc. New York; 4 th edition; Page: 30-42 2)Guidelines on cGMP and quality of pharmaceutical products; S. Iyer; D. K. Publications, Mumbai; 1 st edition-2003; Page: 9-13, 289-294 3)Good Laboratory practice Regulations; Sandy Weinberg; Marcell Dekker, Inc. New York; 2 nd edition-1995; Page: 41-53 4)Pharmaceutical Industrial management; G. Vidyasagar; Pharma book syndicate, Hydrabad-2005; Page: 88-92, 173-178 5) www.fda.gov/ora/compliance ref/bimo/comparision chart 6) www.cipd.co.uk/subject/hrpract/psnrcrd/retrrecords.htm You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Organization and peronnel GMP nishit_patel5 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: Embed: Flash iPad Dynamic Copy Does not support media & animations Automatically changes to Flash or non-Flash embed WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 648 Category: Science & Tech.. License: All Rights Reserved Like it (0) Dislike it (0) Added: December 08, 2011 This Presentation is Public Favorites: 1 Presentation Description No description available. Comments Posting comment... By: shradhanjalising (9 month(s) ago) dear friend nice ppt on UV visible instrumentation. Could you plz send this ppt on singhshradhanjali@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: dlingam6 (10 month(s) ago) ver good Saving..... Post Reply Close Saving..... Edit Comment Close By: sumalathaglory (14 month(s) ago) Hi, this ppt was really informative can you please send the ppt of LCMS to my glory.sumalatha@gmail.com Saving..... Post Reply Close Saving..... Edit Comment Close By: kasturi1995 (15 month(s) ago) ongrets its very best ppt please send me on my email madhuripbhise@gmail.com Thankin You Saving..... Post Reply Close Saving..... Edit Comment Close By: vhbhaskar (16 month(s) ago) Dear friend,Its nice Ppt. regarding IND and NDA.. Please send me on my email rajgornaresh@gmail.com. Havee a nice day Saving..... Post Reply Close Saving..... Edit Comment Close loading.... See all Premium member Presentation Transcript PowerPoint Presentation: Prepared by: Guided by: Dipali S. Patel Dr. Nehal J. Shah M.Pharm (Q.A.) Principal 1 st Semester DDPC Dharmaj Degree Pharmacy College 1PowerPoint Presentation: 2 RESPONSIBILITIES OF QUALITY CONTROL UNIT: (1) (a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, and the authority to review production records to assure that no errors have occurred, or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company. (b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, inprocess materials, and drug products shall be available to the quality control unit.PowerPoint Presentation: 3 c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. (d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed. The regulations clearly assign to the quality control (QC) unit responsibility for approval or rejection of components, in-process materials, and products.PowerPoint Presentation: 4 The CGMPs focus all responsibility for quality onto the QC unit. There are no defined responsibilities for production management—unlike the European and World Health Organization (WHO) guidelines, which define both separate and joint responsibilities for these functions. This latter approach more clearly emphasizes that the consistent achievement of quality standards requires a team effort. A more effective approach has been to design quality into products during the development phase and then to build in additional assurance during production.PowerPoint Presentation: 5 Within the production operations all quality-impacting procedures and systems are to be approved by QC. Typically, these include such procedures as standard operating procedures (SOPs), process validation protocols, supplier certification protocols, complaint handling, process control procedures, and even design of buildings. QC has effective procedures to ensure that such systems are reviewed in a timely manner and that changes cannot be introduced without approval. During 1985 and 1986 several companies had serious problems associated with changes in formulations and manufacturing processes, which then failed to comply with requirements of NDA and ANDA documentation. These discrepancies resulted in halting of distribution and recalls, with significant loss of revenue to the companies involved.PowerPoint Presentation: 6 QC is also responsible for approving or rejecting labeling. This responsibility lies in two areas. First, new or modified labeling should be reviewed to ensure that it complies with the ANDA, NDA, OTC monograph, or other official requirements. This checking may be delegated to other functions, but QC must assure that the checkers are qualified to perform their function and that they have done so. Second, incoming labeling supplies are to be evaluated to assure they are correct. These responsibilities do not apply to promotional literature.PowerPoint Presentation: 7 The regulations require adequate laboratory facilities to be available to the QC unit. This clearly allows use of outside laboratories where necessary, but these should be comprehensively evaluated before use. The approval/rejection responsibility also applies to operations contracted out to other companies. This does not necessarily require any additional or duplicate testing. The regulations essentially expect the QC/QA function to provide an independent policy-type role, to monitor the entire production process from purchasing of materials to distribution and use of the product.PowerPoint Presentation: 8 The FDA emphasis for QC is on release and/or rejection authority. These include creation of quality awareness, involvement in product design and development, design and provision of quality training, facilitation for quality improvement, analysis of quality trend data to identify improvement needs and opportunities, identification of quality metrics, and collection and dissemination of quality benchmarking data. These additional activities all enhance the awareness and involvement of senior management, thereby assuring greater emphasis and attention to quality by all functions. With the increased reliance on non-QC personnel for quality-related activities, such as in-process control and customer complaint coordination, the role of the quality assurance (QA) unit has become critical.PowerPoint Presentation: 9 QC should be a resource that plays a positive role in improving profitability. Some companies have gone a step further by insisting that the QC unit should report outside of the plant operations to a group QC function or other scientific or technical function. This arrangement certainly provides an added level of independence and appears to be favored by the FDA. With a totally independent QC unit, there is likely to be a chance of divided responsibility—production to produce and QC to confirm quality.PowerPoint Presentation: 10 Figure 1: Typical plant organization. (1)PowerPoint Presentation: 11 It is preferable that the entire plant operate as a quality-aware team, every individual being expected to perform his or her job in such a manner as to achieve the quality standards. QC then becomes a supporting resource. This is more likely to occur if the QC unit reports directly to the leader of the plant team—the plant manager. An adequate degree of independence can be incorporated into the organization by having a clearly defined functional reporting (‘‘dotted line’’) relationship to a suitable scientific professional in the organization (Figure 1). This approach encourages a team spirit, which will result in a higher and more consistent achievement of quality standards.PowerPoint Presentation: 12 PERSONNEL QUALIFICATIONS AND TRAINING: (1) (a ) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee’s functions. Training in current good manufacturing practice (cGMP) shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with cGMP requirements applicable to them.PowerPoint Presentation: 13 b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. (c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.PowerPoint Presentation: 14 The development and training of employees, at all levels, should be seen as a continuous process (Figure 2) in which performance appraisal plays a key role. The GMP regulations do not attempt to define the education, knowledge, skills, or experience required for the different types of job within a pharmaceutical company. This is significantly different from the European and WHO guidelines, which do specify the knowledge and experience requirements for those individuals designated as responsible for production and quality. The consistent achievement of quality standards requires understanding of, and compliance with, established procedures.PowerPoint Presentation: 15 Consequently, initial screening should select only those individuals who have such basic skills as reading, writing, and numeracy. An employee who cannot understand written instructions will find it difficult to follow procedures; an inability to write coherently will inhibit the recording of atypical situations, while a lack of numeracy could make it impossible to perform certain in-process testing such as statistical process controls.PowerPoint Presentation: 16 Figure 2: Training and development cycle. (1)PowerPoint Presentation: 17 In addition to these basic skills required by every employee, there are specific requirements for certain jobs, such as higher qualifications in engineering, chemistry, microbiology, etc. In order to define these additional requirements it is important to perform a knowledge and skills assessment for each job category. Because of the changing environment in which we work it is essential to reevaluate these needs from time to time. Preemployment screening for the purpose of identifying potential security risks is of special importance when the pharmaceutical manufacture involves the handling of controlled substances.PowerPoint Presentation: 18 This screening must not only include careful scrutiny of the potential employee’s personal and previous employment references, but also whatever review of criminal background as may be possible. Once accepted for employment, the initial, or induction, training takes place. This usually occurs on the first day and includes background on the industry, the company—its policies and procedures—and some fundamentals on the importance of the employee’s role to the health and well-being of the ultimate consumer.PowerPoint Presentation: 19 This session tends to be somewhat general in nature and should be followed by the more specific basic training. Basic training will usually take place over a period of time during which the new employee will be closely supervised. During this stage the employee must be fully trained in all relevant techniques associated with the equipment involved and fully understand the procedures to be followed, and must be aware of the potential problems that can be created by nonadherence to these procedures.PowerPoint Presentation: 20 Training programs must include appropriate evaluation steps. These will usually involve some type of evaluation at the end of each module followed by on-the-job appraisal to confirm that the lessons learned have been put into practice. Repeat training should be initiated when necessary. Personnel working in areas where contamination is hazard, e.g., clean areas or areas where highly active, toxic, infectious, or sensitizing materials are handled, should be given specific training. (2)PowerPoint Presentation: 21 Visitors or untrained personnel should preferably not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, practically about personnel hygiene and the prescribed protective clothing. They should be closely supervised. (2) Education and training records must be maintained and kept current; FDA inspectors may ask for confirmation of adequate training. The responsibility for training of employees should reside with departmental management. However, the QC department should monitor or audit to ensure that the appropriate training has been given. This could include review of training module content and also of training records.PowerPoint Presentation: 22 PERSONNEL RESPONSIBILITIES: (1,2,3) (a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. (b) Personnel shall practice good sanitation and health habits. (c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.PowerPoint Presentation: 23 (d) Any person shown at any time (either by medical examination or by supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.PowerPoint Presentation: 24 The use of plant uniforms is generally a more satisfactory way of maintaining adequate standards of dress and the following guidelines may be applied: 1. A sufficient amount of clean uniforms is provided so that changes can be made at an adequate defined frequency or whenever they became soiled. 2. Washing and sanitation procedures should be checked to confirm their effectiveness. 3. Employees in special clean areas should wear only lint-free garments to prevent shedding. 4. Garments should be designed and use material that maximizes personal comfort.PowerPoint Presentation: 25 5. The range of clothing available would normally include: a. Hats or hair cover b. Beard and moustache covers c. Coveralls—preferably with no pockets, or pockets suitably designed to prevent articles falling out d. Disposable gloves e. Foot covers or shoes f. Masks g. Safety glasses or goggles h. Appropriate clean-room suits for sterile areasPowerPoint Presentation: 26 6. Employees should be shown how and when to wear the appropriate clothing. 7. Work clothing should not be worn outside of the appropriate plant area, and changing rooms should be available. The continued wearing of such clothing in cafeteria areas during breaks should also be evaluated. Food particles in and on clothing can introduce bacterial, fungal, and yeast contamination. Obviously, operators in sterile areas will change prior to leaving the area, and this may be desirable for some other areas, especially to minimize the potential for cross-contamination.PowerPoint Presentation: 27 Preemployment medical examination (include some medical history, chest x-ray, Wassermann test, and tuberculosis test) and Annual medical reexaminations are required. Ideally, these employees should be allowed to work at tasks in which they cannot contaminate products and at their usual rate of pay. The primary objective of this section of the regulations is to protect the product from potential contamination from personnel—particulate matter including hair, fibers, and outside ‘‘dirt,’’ cross-contamination carried on clothing from other processes, microorganisms shed from skin and from the mouth and nose.PowerPoint Presentation: 28 The head of production and quality control departments generally have some shared, or jointly exercised , responsibilities relating to quality. (2) which include, The authorization of written procedures and other document including amendments. The monitoring and control of manufacturing environment. Plant hygiene Process validation and calibration of analytical apparatus. The approval and monitoring of suppliers of materials.PowerPoint Presentation: 29 The approval and monitoring of contract manufacturers. The designation and monitoring of storage conditions for materials and products. The retention of records. Monitoring of compliance with GMP requirements. The inspection, investigation and taking of samples, in order to monitor the factors that may affect product quality.PowerPoint Presentation: 30 The head of the production department generally has the following responsibilities. (2) To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. To approve the instruction relating to production operations, including the in-process controls, and to ensure their strict implementation. To ensure that the product records are evaluated and signed by a designated person before they are made available to the QC-department.PowerPoint Presentation: 31 To check the maintenance of the department, premises, and equipment. To ensure that the appropriate process validations and calibrations of control equipments are performed and recorded and the records are made available. To ensure that the required initial and continuing training of production personnel is carried out and adapted according o need.PowerPoint Presentation: 32 The head of quality control department generally has the following responsibilities , (2) To approve pr reject the starting materials, packaging materials and intermediate, bulk and finished products. To evaluate batch records. To ensure that all necessary testing is carried out. To approve sampling instructions, specifications, test methods and other quality control procedures.PowerPoint Presentation: 33 To approve and monitor analyses carried out under contract. To check the maintenance of the department, premises and equipments. To ensure that the appropriate validation including those of analytical procedures, and calibrations of control equipments are done. To ensure that the required initial and continuing training of quality control personnel is carried out and adapted according to need.PowerPoint Presentation: 34 Testing facility management’s (TFM’s) responsibility: (according to GLP) (3) Designate a study director before study is initiated. Replace the study director promptly if it becomes necessary to do so during the conduct of the study. Assure that there is a quality assurance unit. Assure that the test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.PowerPoint Presentation: 35 Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled. Assure that personnel clearly understand the functions they are to perform. Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.PowerPoint Presentation: 36 Study director’s responsibility: (according to GLP) (3) The protocol, including any change, is approved as provided and is followed. The study director does not approve the protocol but only makes certain that approval is obtained from sponsor management. All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.PowerPoint Presentation: 37 d) Test systems are as specified in the protocol. e) All applicable GLP regulations are followed. f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.PowerPoint Presentation: 38 Responsibility of Quality Assurance unit: (according to GLP) (3) A testing facility shall have a QA unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, and controls are in conformance with the regulations in this part. The QA unit shall: Maintain a copy of master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test articles and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.PowerPoint Presentation: 39 Maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible. Inspect all nonclinical laboratory study at interval adequate to assure the integrity o study and maintain written and properly signed records of each periodic inspection. Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.PowerPoint Presentation: 40 Determine that no deviations from approved protocols or SOPs were made without proper authorization ad documentation. Review the final study report to assure that such report accurately describes the methods and SOPs. Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.PowerPoint Presentation: 41 The responsibilities and procedures applicable to the QA unit and the method of indexing such records shall be in writing and shall be maintained. A designated representative of the FDA shall have access to the written procedures established for the inspections and may request testing facility management to certify that inspections are being implemented, performed, documented and followed-up accordingly.PowerPoint Presentation: 42 Responsibility of Quality Assurance unit: (2) Ensure feasibility of new projects or products for customer specifications. Availability of specifications based on customer requirements. Approval of procedures/methods, processes, specifications and other relevant documents. Availability of adequate resources and facilities and procedures for scale up studies, stability of new products. Authorization before final transfer of information to QA and production. To ensure that all personnel are adequately trained and arrange for continuing training whenever necessaryPowerPoint Presentation: 43 Functions of Personnel Management : (4) Recruitment of personnel Placement of labour force Providing training tro those who need such a training for improving their efficiency and skill Improving the job performance Soliciting creative cooperation from the labour force Developing better coordination and good cordial industrial relations Providing explanation and interpretation of the policies and procedure of the organization h) Controlling labour cost creating soothing work atmosphere.PowerPoint Presentation: 44 PERSONNEL HYGIENE: (2) All personnel, prior and or during employment should undergo health examinations. Personnel conducting visual inspection should also undergo periodic eye examinations. All personnel should be trained in the practices of personnel hygiene. A high level of personnel hygiene should be observed by all those concerned with manufacturing process. In particular, personnel should be instructed to wash their hands before entering the manufacturing areas.PowerPoint Presentation: 45 Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study shall be excluded from direct contact with test systems and any other operation or function that may adversely affect the study until the condition is corrected. All employees should be instructed and encouraged to report to their immediate supervisor any conditions (relating to plant, equipment or personnel) that may adversely affect the products. Direct contact should be avoided between the operator’s hand and staring materials, primary packaging materials, and intermediate or bulk product.PowerPoint Presentation: 46 To ensure protection of the product from contamination, personnel should wear clean body covering appropriate to the duties they perform, including appropriate hair covering. Used clothes should be stored in separate closed containers until properly laundered and, if necessary, disinfected or sterilized. Smoking, eating, drinking, chewing and keeping plants, food, drink, smoking material, and personnel medicines should not be permitted in production, laboratory and storage areas or in any other areas were they might adversely influence product quality. Personnel hygiene procedures including the use of protective clothings should apply to all persons entering production areas, where they are temporary or fulltime employees or non-employees. E.g., containers’ employees, visitors, senior manager and inspectors.PowerPoint Presentation: 47 PERSONNEL RECORDS : (5) All the records must be maintained and kept current; FDA inspectors may ask for it anytime. They must be in proper format. They must be retained for a specific time period.PowerPoint Presentation: 48 Record Statutory retention period Statutory authority accident books, accident records/reports 3 years after the date of the last entry The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) Manufacturing records At least 5 years from date of manufacture Drug and cosmetic act-1940 accounting records 3 years for private & 6 years for public limited companies Section 221 of the Companies Act 1985PowerPoint Presentation: 49 income tax and NI returns, income tax records not less than 3 years after the end of the financial year to which they relate The Income Tax (Employments) Regulations 1993 medical records 40 years from the date of the last entry The Control of Lead at Work Regulations 1998 medical records under the Ionising Radiations Regulations 1999 until the person reaches 75 years of age, but in any event for at least 50 years The Ionising Radiations Regulations 1999PowerPoint Presentation: 50 records of tests and examinations of control systems and protective 5 years from the date on which the tests were carried out The Control of Substances Hazardous to Health Regulations 1999 (COSHH) records relating to children until the child reaches the age of 21 Limitation Act 1980 wage/salary records (also overtime, bonuses, expenses) 6 years Taxes Management Act 1970PowerPoint Presentation: 51 Comparison of FDA, EPA, OECD-GLP principles with respect to Organization & Personnel:PowerPoint Presentation: 52 Topic FDA EPA OECD-GLP Training & Experience of Personnel (a) Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions. (a) Each individual engaged in the conduct of or responsible for the supervision of a study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions. (a)All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good Laboratory Practice which are applicable to their involvement in the study.PowerPoint Presentation: 53 Summary of Training & Job Descriptions (b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a nonclinical laboratory study. (b) Each testing facility shall maintain a current summary of training and experience and job description for each individual engaged in or supervising the conduct of a study. (b) ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;PowerPoint Presentation: 54 Sufficient Personnel (c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol. (c) There shall be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol. (c) ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study;PowerPoint Presentation: 55 Personnel Health Precautions (d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test and control articles and test systems. (d) Personnel shall take necessary personal sanitation and health precautions designed to avoid contamination of test, control, and reference substances and test systems. (d) Study personnel should exercise health precautions to minimize risk to themselves and to ensure the integrity of the study.PowerPoint Presentation: 56 Clothing for Personnel (e) Personnel engaged in a nonclinical laboratory study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test and control articles. (e) Personnel engaged in a study shall wear clothing appropriate for the duties they perform. Such clothing shall be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test, control, and reference substances.PowerPoint Presentation: 57 Personnel Illness Precautions (f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study shall be excluded from direct contact with test systems and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors. (f) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the study shall be excluded from direct contact with test systems, test, control, and reference substances and any other operation or function that may adversely affect the study until the condition is corrected. All personnel shall be instructed to report to their immediate supervisors any health or medical conditions that may reasonably be considered to have an adverse effect on a study. (f) They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.PowerPoint Presentation: 58 TFM - Assure Appropriate Testing (a) Assure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. (a) Assure that test, control, and reference substances or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable. (a) ensure that test and reference items are appropriately characterized;PowerPoint Presentation: 59 TFM- Assure Availability of Resources (b) Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled. (b) Assure that personnel, resources, facilities, equipment, materials and methodologies are available as scheduled. (b) ensure that test facility supplies meet requirements appropriate to their use in a study;PowerPoint Presentation: 60 TFM - Assure Corrective Actions (c) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented. (c) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.PowerPoint Presentation: 61 General Responsibilities of a Study Director (a) For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. (a) For each study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation, and reporting of results, and represents the single point of study control. (a) The Study Director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.PowerPoint Presentation: 62 Study Director - Recording & Verification of Data (b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. (b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified. (b) ensure that all raw data generated are fully documented and recorded;PowerPoint Presentation: 63 Study Director - GLP Compliance (c) All applicable good laboratory practice regulations are followed. (c) All applicable good laboratory practice regulations are followed. (c) sign and date the final report to indicate acceptance of responsibility for the validity of data and to indicate extent to which the study complies with these Principles of GLP;PowerPoint Presentation: 64 Study Director - Archiving (d) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study. (d) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study. (d) Ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.PowerPoint Presentation: 65 QAU General Responsibilities (a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. (a) A testing facility shall have a quality assurance unit which shall be responsible for monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations in this part. The quality assurance unit shall conduct inspections and maintain records appropriate to the study. 1) The test facility should have a documented Quality Assurance Programme to assure that studies performed are in compliance with these Principles of Good Laboratory Practice. 2) The Quality Assurance Programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.PowerPoint Presentation: 66 QAU Independence (a) For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. (a) For any given study, the quality assurance unit shall be entirely separate from and independent of the personnel engaged in the direction and conduct of that study. This individual(s) should not be involved in the conduct of the study being assured.PowerPoint Presentation: 67 QAU - Maintain Copy of Master Schedule (1) Maintain a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the testing facility indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director. (1) Maintain a copy of a master schedule sheet of all studies conducted at the testing facility indexed by test substance and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director. (a) have access to an up-to-date copy of the master schedule;PowerPoint Presentation: 68 QAU - Maintain Copies of Protocols (2) Maintain copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible. (2) Maintain copies of all protocols pertaining to all studies for which the unit is responsible. (a) maintain copies of all approved study plans and Standard Operating Procedures in use in the test facilityPowerPoint Presentation: 69 QAU - Inspections (3) Inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection. (3) Inspect each study at intervals adequate to ensure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for re-inspection. (c) Conduct inspections to determine if all studies are conducted in accordance with these Principles of Good Laboratory Practice. Inspections should also determine that study plans and Standard Operating Procedures have been made available to study personnel and are being followed. Inspections can be of three types as specified by Quality Assurance Programme Standard Operating Procedures: Study-based inspections, Facility-based inspections, Process-based inspections. Records of such inspections should be retained.PowerPoint Presentation: 70 QAU - Reporting 1) Any problems found during the course of an inspection which are likely to affect study integrity shall be brought to the attention of the study director and management immediately. 2) Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken. 1) Any problems which are likely to affect study integrity found during the course of an inspection shall be brought to the attention of the study director and management immediately. 2) Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken. 1) promptly report any inspection results in writing to management and to the Study Director, and to the Principal Investigator(s) and the respective management, when applicable;PowerPoint Presentation: 71 QAU - Assure Deviations are Authorized (3) Determine that no deviations from approved protocols or SOPs were made without proper authorization and documentation. (3) Determine that no deviations from approved protocols or SOPs were made without proper authorization and documentation.PowerPoint Presentation: 72 QAU - Review of Final Report (4) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study. (4) Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study. (4) inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies;PowerPoint Presentation: 73 QAU - Final Report Statement (5) Prepare and sign a statement to be included with the final study report which shall specify the date’s inspections were made and findings reported to management and to the study director. (5) Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director. (5) prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the Study Director and Principal Investigator(s), This statement would also serve to confirm that final report reflects the raw data.PowerPoint Presentation: 74 QAU - Responsibilities & Procedures (6) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees of the Food and Drug Administration. (6) The responsibilities and procedures applicable to the quality assurance unit, the records maintained by the quality assurance unit, and the method of indexing such records shall be in writing and shall be maintained. These items including inspection dates, the study inspected, the phase or segment of the study inspected, and the name of the individual performing the inspection shall be made available for inspection to authorized employees or duly designated representatives of EPA or FDA.PowerPoint Presentation: 75 QAU - Management Certification of QAU Inspections (7) A designated representative of the Food and Drug Administration shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed-up in accordance with this paragraph. (7) An authorized employee or a duly designated representative of EPA or FDA shall have access to the written procedures established for the inspection and may request testing facility management to certify that inspections are being implemented, performed, documented, and followed up in accordance with this paragraph.PowerPoint Presentation: 76 References: Good Manufacturing Practice for Pharmaceuticals; Sidney H. Willig, James R. Stoker; Marcell Dekker, Inc. New York; 4 th edition; Page: 30-42 2)Guidelines on cGMP and quality of pharmaceutical products; S. Iyer; D. K. Publications, Mumbai; 1 st edition-2003; Page: 9-13, 289-294 3)Good Laboratory practice Regulations; Sandy Weinberg; Marcell Dekker, Inc. New York; 2 nd edition-1995; Page: 41-53 4)Pharmaceutical Industrial management; G. Vidyasagar; Pharma book syndicate, Hydrabad-2005; Page: 88-92, 173-178 5) www.fda.gov/ora/compliance ref/bimo/comparision chart 6) www.cipd.co.uk/subject/hrpract/psnrcrd/retrrecords.htm