Batch Manufacturing Record and Master Formula Record

1. Guided by: Dr. Sanjeevani. R. Desai. Presented by: Mr. Akshay. S. Dhole M. Pharm- I Year (Associate Professor) Department of Quality Assurance Vasantidevi Patil Institute of Pharmacy, Kodoli

2. • What is document? •Types of documentation. • BMR • MFR

3. Document is a paper that provides information especially of an official or legal nature, written report or record Documentation: It is method of preparing written material which describes the process in terms of specification

4. BMR (Batch Manufacturing Record) MFR (Master Formula Record)

5.  The "Batch Manufacturing Record" is the necessary quality and GMP documentation for tracing the complete cycle of manufacturing batch or lot.  The batch manufacturing record should be checked before issuance to assure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction.

6.  Before any processing begins, a check should be performed and recorded to ensure that the equipment and workstation are clear of previous products, documents, or materials not required for the planned equipment is clean and suitable for use.  These records should be numbered with a unique batch or identification number and dated and signed when issued.

7. BMR CONTENT :-  Name of the product  Strength  MFR no:-master formula record  BMR no:  Signed & issued by QA  Signed for completion by production  Bill of materials: It is a list of all raw material ingredients that are required involving more materials which do not appear in the final product.

8. A good BMR format should contain following parts: 1. Batch record: First page of the BMR has all records about the batch as batch no. , batch size, composition MFR , weight of drug shelf life, storage condition, manufacturing date, expiry date.

9. 2. General instruction for mfg: Health and safety instruction to the operation and be followed during the mfg process regarding equipment used during mfg. the material and

10. 3. Equipment cleaning record: cleaning of all equipment is prepared. Those are used in manufacturing of the batch including the previous product batch and date of cleaning. Check list of the

11. 4. Bills of materials: list of the raw materials should have the quantity of the material with that AR number. Weight of the material should be verified by QA.

12. 5. Manufacturing Process:- Should be written step by step in easy language. Milling, Shifting, Drying, Compression, Coating instruction with process time should be written. and Packing having all

14. 6. Yield: Yield of batch should be calculated at the end of every stage to calculate the process loss. Final yield should be calculated at the end of manufacturing that should not be less than 99 %.

15. 7. Abbreviations: list of used in document should be made to understand the BMR easily. 8. History of changes: At the end of document should have a list of the changes in the document including the revision no. and date of change.

16. Documentation of completion of each significant step in the BMR should include:  Specific weights, materials, intermediates, or any reprocessed materials used during manufacturing.  Signatures of the persons performing and directly supervising or checking each critical step in the operation.  In-process and laboratory test results.  Actual yield at appropriate phases or times.  Any deviation noted, its evaluation, and investigation conducted (if appropriate) investigation (if stored separately). identification measures, of each batch batch, numbers including of and raw or reference to that

17.  Results of release testing.  Production and quality control records should be reviewed as part of the approval process of batch release.  Any divergence or failure of a batch to meet its specifications should be thoroughly investigated.

18. BATCH MANUFACTURING ATTACHMENTS Responsibility:-  Primary:- Production Chemist  Secondary:- Production Officer

19. FOLLOWING ATTACHMENTS REQUIRED TO BE ATTACHED TO BMR BE COMPLETED BMR TO QUALITY ASSURANCE:- ✓ Equipment clean record status label. ✓ Equipment clean record. ✓ Raw materials dispensed weighing slip. ✓ Intermediate raw material sealed. ✓ Transfer note for finished goods to F.G. store. ✓ Raw material issue order (P.R). ✓ IPQC-In Process Test Request Cum Report. ✓ Excess material requisition (S.R.). ✓ Deviation note if any. ✓ Certificate of Analysis (COA). ✓ Finish product dispatch data.

20. MFR (Master Formula Record ). It should be available for each product, batch and pack size. 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. • • • • • •

21. MFR is also called Master Manufacturing Record. MFR plays an important in consistency for each batch manufacturing. • •

22. Content of MFR 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. Shelf life. Storage conditions.

23. MFR number and date. Supersede MFR number and date Effective batch number. Authorization by the production and quality assurance head.

24. MFR Packaging details:-  There have to be authorized packaging instructions:  Name.  Description of dosage form.  Pack sizes- Number, dose volume.  A total list of all Packaging materials required for standard batch size specifications of the packaging material  Specimens of all packaging material.  Line clearance instructions.  Description of packaging operations.  In process controls. with reference to the