REGULATORY AFFAIRS & MASTER FORMULA RECORD

Detail inormation about MFR

1. REGULATORY AFFAIRS & Master Formula Record SACHIN SURYAWANSHI M. PHARM

2. Regulatory affairs a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. 2

3. Role of Regulatory Affairs R agistration Documents To Regulatory Agency To Keep Track On Every Change In Legislation To Give Strategic And Technical Advice to R&D Production And QC Department 3

4. Departments In DRA Drug Regulatory Authorities CDSCO – India USFDA – US MHRA – UK TGA – Australia EMEA – Europian country MCC – South Africa Internal Department Of Organization Product Development Clinical Trail & R eserch Licencing QA QC Mfg Marketing 4

5. MASTER FORMULA RECORD Master Formula Record (MFR) is a master document for any pharmaceutical product. MFR contains all information about the manufacturing process for the product. MFR is prepared by the research and development team of the company. MFR is used as reference standard for preparing batch manufacturing record (BMR) by manufacturing units. MFR is also called Master Manufacturing Record, Master Production Record. 5

6. Definition MFR “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 .” 6

7. MFR should include - Product Details : Name, logo and address of the manufacturing company. Dosage form name. Brand name. Generic name. Product code Label claim of all ingredients Product description Batch size Pack size and packing style 7

8. Procedure to prepare a Master Formula Record: A Master Formula Record is either prepared based upon experience of competent qualified staff like manufacturing chemist or analytical chemist or prepared based upon batch manufacturing record of a batch size. We can’t ignore Master formula record at any level. Once Master Formula Record is prepared, it is transferred to previous staff to new staff. It is followed as standard documents for processing a batch. Master Formula record is consider as standard for making a Batch Manufacturing Record. 8

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