Documentation in Pharmaceutical Industry.pptx

Documentation maintained in Pharmaceutical Industry

1. Dr. Prakash Goudanavar DEPARTMENT OF PHARMACEUTICS Sri Adichunchanagiri College of Pharmacy. Documentation in Pharmaceutical Industry

2. DOCUMENTS Quality can not be assured in a regulated industry without good documents and good documentation practices. A document system is an interdependent, interrelated set of documents, each with a defined purpose and a consistent format. Documentation is a process that involves the systematic interaction of people, events and documents to create the records of the organization / corporation. 2

3. Documentation for QMS. Documents -procedural or instructional documentation. Records -evidence of compliance. 21CFR part 211subpart J EU GMP Chapter 4. ICH Q7 section 6. Drugs and Cosmetics Act schedule M & U . 7/15/2022 3

4. Documentation for QMS Records. Data – Documents and Records. Batch Manufacturing Record, Analytical Report, Validation Report etc. Invaluable communication tool for Business. Provides background history. Preserves learning and knowledge. Protects intellectual property. Provides legally valid evidence. Ensures the quality and consistency of processes/activities/manufacturing. 4

5. Documentation and Records. Documentation System Quality Policy. Quality Manual. Site Master File. Standard Operating Procedures(SOPs). Qualification : Protocols and Records. Validation: Protocols and Records. Process Development Reports. Technology Transfer Reports. Training Records . 5

6. Good Documentation Practices. General Requirements. Deliberately amending and destroying GMP records to hide or falsify data is fraud. Do not discard a GMP record just because you might have made mistake, it is still required for traceability. It is not acceptable to discard GMP records for any reason unless the retention period expiry is reached. Loose unofficial papers notes and uncontrolled documents that can easily be lost or changed without appropriate approval do not meet GDP requirements. Do not use note books/legal pads with easily removed pages, scrap paper or post-it-notes to record GMP information. 7/15/2022 6

7. Master Formula Records A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.” 7/15/2022 7

8. There shall be Master Formula records relating to all manufacturing procedures for each product and batch size to be manufactured. These shall be prepared and endorsed by the competent technical staff i.e. head of production and quality control. 7/15/2022 8

9. The master Formula shall include (a) the name of the product together with product reference code relating to its specifications;   (b) the patent or proprietary name of the product along with the generic name, description of the dosage form, strength, composition of the product and batch size; 7/15/2022 9

10. (c) a statement of the processing location and the principal equipment to be used. (d) name, quantity, and reference number of all the starting materials to be used. Mention shall be made of any substance that may .disappear. in the courts of processing.   (e) a statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable. 10

11. (f) The methods, or reference to the methods, to be used for preparing the critical equipment's including cleaning, assembling, calibrating, sterilizing.   (g) detailed stepwise processing instructions and the time taken for each step;   (h) the instructions for in-process control with their limits; 7/15/2022 ARCP, V.V.NAGAR 11

12. (i) the requirements for storage conditions of the products, including the container, labelling and special storage conditions where applicable;   (j) any special precautions to be observed; and   (k) packing details and specimen labels. 12

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17. DRUG MASTER FILE A Drug master File ( DMF ) is a submission to the Food and Drug Administration ( FDA ) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Objective: To support regulatory requirements and to prove the Quality, Safety and Efficacy of the medicinal product. 17

18. REMEMBER There is no legal or regulatory requirement to file a DMF. The information contained in DMF may be used to support an - Investigational New Drug Application (IND), - New Drug Application (NDA), - Abbreviated New Drug Application (ANDA) - An Export Application DMF is NOT a substitute for IND / NDA / ANDA or export application . 18

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20. TYPES OF DRUG MASTER FILES 20

21. SUBMISSIONS TO DRUG MASTER FILES Each DMF submission should contain a transmittal letter, administrative information about the submission, and other specific information. The DMF must be in the English language . Whenever a submission contains information in another language, an accurate certified English translation must also be included. Each page of each copy of the DMF should be dated and consecutively numbered. An updated table of contents should be included with each submission. 7/15/2022 ARCP, V.V.NAGAR 21

22. PROCEDURE FOR ACTIVE SUBSTANCES An Active Substance Manufacturer (ASM) RESTRICTED PART OF DMF APPLICANT’S PART OF DMF OPEN PART CLOSED PART Content of Drug Master File 7/15/2022 ARCP, V.V.NAGAR 22

23. APPLICANT’S PART OF DMF OPEN PART ( AVAILABLE TO APPLICANT) Active substance manufacturer Supplies information to the applicant This information includes: outline of the manufacturing method impurities originating from the manufacturing method, isolation procedure and degradation information on the toxicity of specific impurities 7/15/2022 ARCP, V.V.NAGAR 23

24. The applicant’s part of a DMF is provided by the ASM to the applicant directly and becomes part of the application for marketing authorization. The applicant’s part of the DMF is still a confidential document which cannot be submitted to third parties without the written agreement of the ASM. 7/15/2022 ARCP, V.V.NAGAR 24

25. ASM RESTRICTED PART OF DMF CLOSED PART ( NOT AVAILABLE TO THE APPLICANT) IT INCLUDES: Detailed information about… Individual steps of the manufacturing method such as reaction conditions, temperature , etc. Validation and evaluation data for certain critical steps of the manufacturing method, etc 7/15/2022 ARCP, V.V.NAGAR 25

26. Distribution of records Maintainence of records of finished product is essential to facilitate complete recall of batch if necessary. Distribution records are written data related to distribution of drug products from the manufacturer to the distributors. The complete data regarding all batches of drug products should be maintained. 26

27. Distribution records should contain Name Strength of product Description Name & address of consignee Date Control number of drug product Information regarding drug products should be readily available so that product recall is efficient. 27

28. An inventory card may be maintained to find out stock position quickly. Distribution register should be maintained. Inventory card format Inventory card M/S (Name & address of company) Name of product: 28

29. Distribution register format 29 Distribution records includes documentation such as invoices,bills of loading,customer receipts,internal warehousing storage & inventory records

30. References:- www.fda.gov www.fda.gov/cder/guidance/dmf.html www.emea.eu.int/htms/vet http://www.fda.gov/cder/Offices/ONDQA/presentations/shaw.pdf 30

31. 31 ARCP, V.V.NAGAR