MANUFACTURE OF AND CONTROL OF DOSAGE FORM

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MANUFACTURE OF AND CONTROL OF DOSAGE FORMS: MANUFACTURING DOCUMENTS-MFR,BMR,BPR,SOPs QUALITY AUDITS OF MANUFACTURING PROCESSES AND FACILITIES:

MANUFACTURE OF AND CONTROL OF DOSAGE FORMS: MANUFACTURING DOCUMENTS-MFR,BMR,BPR,SOPs QUALITY AUDITS OF MANUFACTURING PROCESSES AND FACILITIES Guided BY: Mrs. Ridhdhi Madhu Mr. Vijendra chauhan Presented BY: Radadiya Rakesh M.pharm-1 (Q.A.) Mts. V. B. Manvar College of Pharmacy, Dumiyani

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Content Master formulae record Batch manufacturing record Batch Packaging record Standard Operating Procedure Quality Audit of Manufacturing Process & Facilities

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In all industry all the record like BMR,BPR,MFR,SOP of all process nad equipment are maintained. Its structure varies from company to company with accordance with established procedure. Benefits of Manufacturing Documents Reduce costs labour expense Improve Productivity by accomplishing tasks more accurately and efficiently Reduce storage costs Decreasing time and cost with managing compliance program 2. Reduce cycle time Shorten time to market Improve order fulfillment Supply chain collaboration Support lean manufacturing Streamline any business process by converting to a paperless, rules based and workflow.

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3.Increase service level Improve issue resolution methods Documents customer requirement Share knowledge assets Strengthen customer/partner relation Increase sales proficiency 4.compliance-Regulatory, corporate policies, and certification assistance ISO Compliance FDA Compliance OSHA Compliance Corrective and Preventive Action (CAPA) Compliance Sarbanes-Oxley (SOX) Compliance Manage adherence to company and governmental policies Disaster Recovery practices

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Application for Manufacturing Documents Accounting – Account receivables/payables processing Customer Service – Order processing, complete customer profiling, resolution handling Engineering – Change Process Management, archival Human Resources – Sensitive employee document control and management, hiring processing Operations - Continuous Improvement Planning (CIP) initiatives and project management Quality Assurance – Issue resolution, documented standards processes, safety compliance Regulatory Compliance – Complete document security and audit trail capabilities Risk Aversion – Complete disaster recovery; modular/ scaleable in design Sales – Catalog management, vendor contracts

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PURPOSE To provide a procedure for document control. SCOPE To ensure a complete control over all the authorized documents. RESPONSIBILITY : QA Personnel Document Control SOP

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PROCEDURE : All documents should be identified by a unique title and document number. Document should be designed, prepared, received, approved, signed and dated by authorized persons and distributed to concerned departments. Approved documents should not be corrected manually with a pen / pencil for any reason Master formula record to be prepared by QA in consultation with Formulation development, Production and Quality Control. Master formula record includes : Preparation of Documents Master Formula Record

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Batch Manufacturing record (BMR). Batch Packing record (BPR). Intermediate/ Packing Material / Finished product specification. Specimen of Printed packaging material. All documents of “ Master Formula Record” should be stamped as “Master Copy” in Green at the non- text side (back side). Batch Manufacturing Records consists of following. Manufacturing Work Order. Coating Work Order Stage wise processing details In-process checks Compression and coating (Tablets) Deviation (if any) Batch Packing Records consists of following. Packing work order. Over printing details Packing details In-process checks Over printing Bottle washing and filling (liquid orals) Bottle cleaning and filling (Dry Syrup) Packing

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Shipper weight profile Deviation record (if any) Document Issuing During the issue of a document the necessary entries have to be made in the respective document control register with details of Document name, Document number, Issued by, received by, Retrieved document No., (if any) Number of copies retrieved, destroyed by, Date, Checked by details. BMR / BPR - photo copies of master copy are issued for regular production. All sheets of photo copies should be signed and dated by QA Personnel. Completed batch record should come back to QA for review. After review of the records and QC analytical results, QA will release the batch (Product) for sale. All the completed batch records should be controlled by QA.4.13 All batch record should be retained atleast for five year after the shelf life of the product.

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MFR should include following information. Name of product, description of dosage form, its strength 2. Complete list of ingredient, designated by whole name and code sufficient specific to indicate any special characteristic. 3. Quantity by wt/volume of each ingredient. 4. Std/specification of each ingredient used in the product. Appropriate statement concerning any calculated excess of an ingredient. Appropriate statement of the yield at various stage and remination of processing. Mfg and control instruction ,specification, precaution ,and special notation to be followed. 8. Detail description of closure, container, labeling,packaging and other finishing material

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Batch Manufacturing Record Structure of BMR varies from company to company, it is possible to highlight their common element. BMR may be prepared in local language. Content and layout of BMR should be as follow…. starting material it should be identified with by their standard names and codes. Issue formula The quantity of the specific batch size with sufficient precision. Title of material All ingredient with complete description with procedure to be followed. Precaution to be followed Equipment to be used Suitable quality control to be taken Appropriate label with container Manufacturing worksheet bearing identification number.

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Material ticket for each raw material are written and issued by production dept to the dept. of material store ,where orders are filled and verified. After material send to the production dept. and checked. Addition of raw material to batch is verified and countersigned by qualified personal. Appropriate label is attached to each container or piece of equipment in use to identify its contents and to ensure that in process stage is properly designated. Any deviation from standard operating condition ,should be reported to both production and control personnel responsible for product. In process checking during manufacturing plays an important role in auditing of quality of product at various stage of production Duties of auditor/control inspector consist of checking, enforcing ,reviewing procedure and suggesting change for upgrading procedure when necessary Primary objective of IPQC system is to monitor all the feature of product that may affect its quality and to prevent errors during processing At completion of manufacturing process as well as in process stage ,actual yield are checked against theoretical value. Representative sample are withdrawn for lab testing by control inspector BMR and other needed document are then delivered to QC office together with withdrawn sample of production. this record and test results are reviewed for conformance to specification and cGMP.

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BATCH PACKING RECORD –BPR This record specify packing material to be to be used, operation to be performed and packaged. Requisition are issued for products to be packed and for packaging and printed material, such as labels, container, insets, brochures, carton and shipping cases. Bulk product and each of the packaging component should be checked ,endorsed and dated by qualified packaging personnel with co operation of control inspector. Proper on line inspection should be made during packaging operation to ensure absence of foreign drugs and labels ,adequacy of container and closure and accuracy of labeling. Yield must be justified against theory represented by the batch size of starting material Suitable procedure should be provided when unexpected discrepancy exists

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Batch Packing Records consists of following . Packing work order. Over printing details Packing details In-process checks Over printing Bottle washing and filling (liquid orals) Bottle cleaning and filling (Dry Syrup) Packing Shipper weight profile Deviation record (if any )

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S O P Why have need SOP ? In January 2005 Government introduced a Requirement for all pharmacist to have SOPs in place, covering dispense process operation in pharmacy. The requirement has been introduced to comply with clinical governance in pharmacy. By having SOPs in place pharmacist are able to show that they operate system of practice which are safe and which encourage continues improvement. Written SOP defines how things are to be done and provided a basis for training of new or located personnel. SOP are the fundamental aspects of the GMPs – the letter should be ideally define what to be achieve SOP provided specific approaches on how to meet the requirement. There should be master sop which described the overall procedure how to initiate/ revise a sop, format who should review and approve

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An authorized written procedure giving instruction for performing the operation not necessarily specific to a given product or material but of more general (e.g. equipment, operation, maintenance, cleaning, validation, cleaning of premises, environmental control of sampling and inspection Definition Objective SOPs help to assure the quality and consistency of the service; SOPs help to ensure that good practice is achieved at all times; SOPs provide an opportunity to fully utilize the expertise of all members of the pharmacy team; SOPs enable pharmacists to delegate and may free up time for other activities; SOPs help to avoid confusion over who does what (role clarification); SOPs provide advice and guidance to locums and part-time staff; SOPs are useful tools for training new members of staff;

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SOPs provide a contribution to the audit process. SOP improved planning and organization SOP reduce introduction of errors and variation in operation Control variation from store to store Improve training Promote safety Improve communication among collages SOPs Prepared BY : GMP expert General manager of production QC general manager QA general manager Nominee of management (technical director) When a test method or process has been developed in-house, the individual who has designed the process and its controls should write the procedure

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WHO GMPs guideline FDA guideline developed by Scale Up And Post Approval Change(SUPAC) SUPAC define procedure and required supporting data for Change in excipient quality and quantity Change in site of manufacturing. Scale up equipment and process changes Equipment and process change NDA/ANDA guideline to define the supporting data requirements for stability, validation, comparative analysis, dissolution profile and allow immediate implementation. Guideline For SOPs

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Format of SOPs and pagination Requirements for document identification and control, accountability and traceability, responsibilities, etc., must be included with every procedure. This can be accomplished by providing a consistent format and consistent document management requirements for every procedure There are no government regulatory agencies such as FDA-approved format for an SOP. There are, however, common expectations within the industry and from regulatory agencies that ensure the accountability, traceability, and consistency of these documents. The format and sample SOPs can be used,modified, or redesigned by each manufacturer according to their organizational structure and by the complexity of their manufacturing operations.

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SOPs should be reviewed (that is, validated) by one or more individuals with appropriate training and experience with the process. It is especially helpful if draft SOPs are actually tested by individuals other than the original writer before the SOPs are finalized. SOPs should be written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised. SOPs should be written in a concise, step-by-step, easy-to-read format. The information presented should be clear and local language. The active voice and present verb tense should be used. The term “You” should not be used but implied. The document should not be wordy, lengthy. It will be short and simple. Also use of flow chart to describe the process In well manner.

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When choosing a format for a procedure, consider the following Company Name And Page number The company name and page number must appear on every page of Document . Title The title should be descriptive. Because a procedure describes how to do something, the title should use directive language to declare what is being done to what. Identification and control Procedures must be uniquely identified. This identification supports accountability and traceability of the document throughout the facility and over time as it changes. The accountability and traceability of procedures are based on assigning them identification numbers or codes and control numbers or codes (e.g., revision or edition numbers). Purpose The purpose or objective of a procedure should restate and expand a well-written title. Scope - The scope should provide limits to the use of the procedure

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Are there certain samples that are appropriate to test by this method? Do these operations apply only to certain equipment or to certain departments? Is there a limit to the capacity, volume, or throughput of the procedure? State to what areas this procedure does and does not apply. Responsibility - Who is responsible for performing the work described? -Who is responsible for reporting the work? -Are there special training or certification requirements Procedure - Describe the procedure in a step-by-step, chronological manner. Use active verbs and direct statements Calculations / data handling / documentation requirements – Describe how the raw data are managed and reported. Provide examples of calculations, when appropriate

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GOOD QUALITY PHARMACEUTICALS PVT. LTD. STANDARD OPERATING PROCEDURE Title:- Department- Procedure No.- Page No.-# of # Effective Date Supersedes Earlier Procedure Date Review Date Objective- Responsibility- Prepared By (GM Production) Checked By (QC Manager) Authorized By (Director Technical)

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OBJECTIVES What is the procedure trying to achieve ? SCOPE What areas of work are to be covered by the procedure? RESPONSIBILITY Who is responsible for carrying out each stage of the process? - Under normal operating conditions? - In different circumstances e.g. when staff is sick/on holiday. OUT LINE FOR PREPARING THE SOPS. THE STAGES OF THE PROCESS Description of how the task is to be carried out . OTHER USEFUL INFORMATION Is there any other information you think could usefully be included in the procedure? Does the SOP incorporate mechanisms for audit? REVIEW How are you going to ensure that the procedure continues to be useful, relevant and up to date?

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These parameters & activities require SOPs 1. Equipment and analytical apparatus: Assembly, validation Calibration Internal labelling, quarantine and storage of materials Operation Maintenance and cleaning 2. Personnel matters: Qualification Training Clothing Hygiene 3. Environmental monitoring 4. Pest control 5. Complaints 6. Recalls 7. Returned goods

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8. SOP and records for receiving materials Name of material as on delivery note Name and in-house code Date of receipt Supplier's and manufacturer's name Batch number Quantity and number of containers received State of container and other information 9. Other SOPs Internal labelling, quarantine and storage of materials Operation, maintenance, calibration and cleaning of all instruments and equipment – production and QC Sampling of materials Batch numbering systems Material testing at all stages of production Complaints, recalls Batch release or rejection Maintenance of distribution records

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Log Books Following Log books should be maintained . Production Department Equipment Operation Equipment Cleaning Planned Preventive Maintenance of Equipment Temperature and Humidity Pressure Differential Balance Calibra General House Keeping Pesto Flash Issue and control of stereos Issue and control of Punches and dies Intermediate log Overprinting of Packaging Materials pH meter log Transfer pump and Transfer line log

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Quality Control Department Instrument Operation and cleaning Volumetric Solutions Reference Standard Working Standards Reserve Sample Control Sample Glass ware calibration Calculation sheet pH meter Distilled water log Autoclave Calibration Sub culturing and destruction of sub culture Media Stock Register De-fumigation checks log Media Preparation Media destruction Growth Promotion test Plate exposure UV lamp log Raw materials analysis

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Quality audit Quality audit is defined as a “ A systemic and independent examination to determine whether quality activities and related result comply with planned arrangements and whether these arrangements are implemented effectively and are suitable achieve objectives. QUALITY AUDITS OF MANUFACTURING PROCESS AND FACILITIES: Manufacturing Process Manufacturing process audit is one of the many quality tools to assess the effectiveness of manufacturing process and quality performance. They are commonly used in the effort to diagnose, maintain and improve quality management system. It is made compulsory for the organization to maintain their quality management system based on ISO9001 standard to conduct an internal audit.

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Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed. Definition Manufacturing process audit can be defined as a process to evaluate the process and making and fabricating effectiveness and efficiency. Purpose The purpose of manufacturing process audit is to improve quality Performance. It is recommended to be conducted either by independently (ISO, 2002), internally (ISO, 2002) or self-assessment(2002) since the goal is to improve quality performance. Effectiveness of the process and opportunities for improvement in achieving organization goals. Compliance audit look for conformance to the audit criteria, while management audit look for conformance to the audit criteria.

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The areas covered in manufacturing audit included manufacturing strategy, new product introduction, process optimization, flexible manufacturing, production system, performance measurement system, technology audit. In pharmaceutical industry Adit of manufacturing procedure can not be performed but auditor must check the parameter of the validated analytical procedure.

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General Criteria for analytical procedure which can check by auditor At procedure Development at research & development stage. Identification of analyte from molecule or product like degradable, impurities &related substances. Preparation of pure reference standard compound to be used for anaytical method. Documentation of analytical method validation. Select a process to be audited Select a team to conduct the audit. Decide how often the process should be observed (the frequency of the audit). Announce the audit in advance so there are no surprises. Set up an audit schedule for the entire shift and follow the established audit schedule. Document any problems discovered and inform all those affected. Determine and perform corrective actions Monitor corrective-action results.

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Quality Audit of Facilities As an internal auditor, we should make sure to pay attention to such considerations as the actual facility itself. Take a look at the grounds and make sure that everything is being maintained properly. Ensuring safety is a key responsibility of an internal audit and this falls under the realm of facility control. Environmental controls, such as lighting and clean air, need to be inspected to assure proper functionality. Facility maintenance and housekeeping also includes any pest control programs. These need special consideration for industries that produce food or medicine.

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Check list for quality audit on facilities: The internal auditor should check the following facilities in manufacturing area for effective process and product as follow. Is there adequate space in the building for the orderly placement of equipment, materials and product? 2. Is the plant layout conductive to smooth product flow? (e.g. uni -directional flow, avoiding back and forth movements). 3. Are operations performed within separate or defined areas of adequate size? 4. Are there dedicated and self-contained facilities (building and equipment )for the manufacturer, processing and packaging of penicillin's? 5. Are there adequate sanitary facilities and designated eating, drinking and smoking areas separate from manufacturing areas? 6. Do the eating and smoking areas have drinking water?

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7. Do change rooms and lavatories: I. Have running water? II. Have soap or detergent? III. Have hard dryers or single-use towels? IV. Have ―wash hands‖ signs? V. Appear clean and sanitary? 8 . Are change rooms designed and used so as to minimize contamination of protective garments? 9. Are the tops of the employee lockers clean? (Check by touching with finger) 10. Is there a written sanitation procedures (sop) containing assignments of responsibility, schedules, methods, equipment and materials to be used to properly clean the building and facilities?

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11. Are records available for sanitation and housekeeping? 12. Is there a formal maintenance schedule for manufacturing equipment and list kept visible near each piece of equipment? 13. Are waste containers with lids located in appropriate areas? 14. Is there an adequate disposal collection system? 15. Are drains to sewers designed with an air or mechanical break to prevent back siphon age? By using these check lists, the internal auditor should maintain a document which is checked, dated and signed by him, super checked by second person.

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Reference Good manufacturing practice for pharmaceuticals second edition; by Sidney H. Willig A consise book of Q.A and Q.C. WHO guideline for SOP Guidance for preparing standard operating procedure EPA QA/G-6 www.worldviewltd.com/ manufacturing .html www.gmpsop.com/pdfmanualsamples/Manual_059_sample.pdf gmponblog.vinvarun.biz/2008/10/document-control-sop.html

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