quality assurance organisations and personal responsibilities

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QA and QC personal responsibilities in the pharma industry which includes manufacturing unit lay outs drug store and packing .

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Organization and personal responsibilities in pharmaceutical industry:

Organization and personal responsibilities in pharmaceutical industry Sharathchandra.s Dept of ph analysis Klr pharmacy college

Contents:

Contents Introduction Organization lay outs types Responsibilities conclusion references

Introduction::

Introduction: Pharmaceutical companies have the responsibility to society to provide pharmaceutical drugs safely and cost effectively . Drug companies are responsible for providing safe pharmaceutical drugs to anyone anywhere in the world and for as long as the drug is prescribed .

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Manufacturing units: It includes both the sterile and non sterile preparations Sterile Unit: It includes the manufacturing of parental large and small volumes along with the manufacturing of some antibiotics. Non Sterile Unit: It includes the manufacturing of the tablets and capsules and powders Organization lay outs

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Responsibilities of the persons working in manufacturing unit: The persons working in the manufacturing unit has the following responsibilities Clothing Gloves Hair covers Had an awareness about the handling of instruments and chemicals Maintenance of hygiene conditions Personal care Persons has to follow the GLP These has to be maintain strictly in the sterile manufacturing unit and in antibiotics

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quality control unit: The section on quality control emphasizes the increased importance of end-product testing in the absence of validated processes. Such that the quality control unit plays the key role in pharma industry There is a brief section on product release, covering the fact that there should be a two stage release process : 1. release of the bulk product prior to packaging; and 2.release of the packaged product, including labelling . This is called the ‘technical green light’ release. introduction

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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. RESPONSIBILITIES OF QUALITY CONTROL UNIT: Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in process materials, and drug products shall be available to the quality control unit

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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 . The CGMPs focus all responsibility for quality onto the QC unit . T he 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. 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.

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QC is also responsible for approving or rejecting labeling. This responsibility lies in two areas Raw materials 2. finished products. 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 QC should be a resource that plays a positive role in improving profitability.

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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. < < < OVER VIEW > > > PERSONNEL RESPONSIBILITIES: 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.

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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. 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 The use of plant uniforms is generally a more satisfactory way of maintaining adequate standards of dress and the following guidelines may be applied:

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f. Masks g. Safety glasses or goggles h. Appropriate clean-room suits for sterile areas 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. Testing facility management’s (TFM’s) responsibility: 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. Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled. 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.

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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. Test systems are as specified in the protocol. All applicable GLP regulations are followed. All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study. Study director’s responsibility: Responsibility of Quality Assurance unit: 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.

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Determine that no deviations from approved protocols or SOPs were made without proper authorization and add 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. The responsibilities and procedures applicable to the QA unit and the method of indexing such records shall be in writing and shall be maintained. 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.

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Statutory bodies WHO USFDA ISO Authorization before final transfer of information to QA and production. 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.

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Drug store management and resp onsibilities: Maintenance of records Storage of bulk, raw materials Personal hygiene Design and lay out Packing: Design lay out Personal hygiene Selection of packing material Records Storage of packed material Shipping Storage of packing materials

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CONCLUSION: Here I conclude that the good organization and lay out in the pharmaceutical industry will give the better results in the quality production

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1] 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 REFERENCES:

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