Drug Master File and Master Formula Record.pptx

Drug Master File and Master Formula Record

1. DOCUMENTATION IN PHARMACEUTICAL INDUSTRY By GOKULRAJ S M.Pharm, Department of Pharmaceutics 1

2. Documentation plays a vital role in the pharmaceutical industry, serves for compliance, quality assurance, and overall operational efficiency. This type of documentations facilitates the maintenance of high quality standards throughout the product lifecycle. Pharmaceutical industry has shifted from paper based to digital documentation for emphasizing the need for long term permanent record keeping 2

3. The development of user friendly computerized system has been identified as a solution to challenges of manual documentation. Good documentation practices GDP is a vital data integrity in the pharmaceutical industry ensuring that documentation is attributable, legible, traceable, permanent and accurate reflecting the true image of the industry. 3

4. Types of documentations : Specifications Manufacturing and packaging instructions Standard operating procedures SOP Records 4

5. 5

6. MASTER FORMULA RECORD 6

7. A document or set of documents specifying the starting material with their packaging materials, together with a description of the procedure and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in process controls. 7

8. MFR is a crucial document, that ensures consistency in each batch of production. Every manufacturing procedures and batch size requires a corresponding MFR, prepared and approved by the competent technical personnel like head of production and head of quality control . 8

9. The MFR contains, Production info - company name, logo, dosage form, brand name, generic name, product code, label claim Batch and pack details - batch size, packing style, shelf life, storage condition Authorization - should be signed by the head of production and quality control List of equipment and calculation for active materials ensuring 100% potency Manufacturing process Packaging process 9

10. Steps for preparing MFR: Production department prepares the MFR, divided into manufacturing and packaging section Detailed instructions includes process to be monitored, equipment used and special precautions In-process checks like yield statements, quality checks, storage conditions and documentations at critical stages 10

11. DRUG MASTER FILE 11

12. Drug master file is a confidential submission to the FDA that contains detailed information about the facilities, process and materials used in the manufacturing, packaging and storage of drugs. DMF provides an accurate and thorough details about a drug product’s chemistry, manufacturing, stability, purity, impurity, packaging and cGmp status for any drug product. 12

13. Types: Types I: Manufacturing site, facilities, procedures and personnel Type II: Drug substance, intermediate, drug product, materials used in manufacturing Type III: Packaging materials Type IV : Excipients, colorants and other additives Type V: FDA accepted reference information 13

14. DMF content: Types of DMF General guidance Environmental assessment Stability Format, Assembly and Delivery: Submit format- submit both original and duplicate for each DMF submission. Copies should be fully assembled, collated and individually jacketed Preferred paper size: 8.5 by 11 inches Margins- left margins is at least three quarters of an inch wide 14

15. DMF FILLING SYSTEM 15

16. DMF Reviewing System 16

17. Reference Nilam D. Chingale , Sushil D. Walunj , Mrunal S. Kiklale et al, Documentation essentials in the pharmaceutical industry: A regulatory Perspective, World Journal Of Pharmaceutical Research,2024;13(11),116-130 Veera Kota Lakshmi Sravantu , Ruchitha Bandha, et al, Filling of DMF in the US, EU and India, and tis comparative review. Interantional Journal of drug regulatory affairs, 2021;9(1),22-32 Pankaj Kumar, Bharti Mangla , Satbir singh , et al, Drug Master File: Global Regulatory Issues and Challenges, European Journal Of Biomedical and Pharmaceutical Science,2018;5(1), 623-626 17

18. THANKS FOR LISTENING 18