BATCH MANUFACTURING RECORD

RELATED T DOCUMENTATION......WRITTEN DOCUMENT DURING THE WHOLE MFG PROCESS.

1. BATCH MANUFACTURING RECORD NAME- CHANDA MALVIYA BANSAL COLLEGE OF PHARMACY

2. RECORD

3. INTRODUCTION What is document Type of document

4. What is document Document is a paper that provide information especially of an official or legal nature ,written report or record. Documentation: It is a method of preparing written material which describe the process in terms of specification instruction.

5. Type of documentation Major two types : BATCH FORMULA RECORD MASTER FORMULA RECORD

6. BATCH MANUFACTURING RECORD The batch manufacturing record [BMR] is the necessary quality and GMP documentation for tracing the complete cycle of manufacturing of a batch or lot. BMR may be prepared in local language. BMR is a written document from the batch that is prepared during the p’ceutical manufacturing process. A good BMR format should contain following part: 1 . Batch record : First page of the BMR has all records about the batch as batch no. ,batch size ,composition MFR, wt of drug shelf life, storage condition ,mfg date ,expiry date date of starting and date of completion.

7. Conti… 2 . General instruction for mfg : Health and safety instruction to the operation and be followed during the mfg process regarding the material and equipment used during mfg. 3 . Equipment cleaning record : Check list of the cleaning of all equipment is prepared. Those are used in the mfg of the batch including the previous product batch and date of cleaning. 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.

8. Conti… 5 . Mfg process : should be written step by step in easy language. Milling ,sifting drying, lubrication, compression, coating and packing having all instruction with process time should be written. 6. Yield: Yield of the batch should be calculated at the end of the every stage to calculate the process loss.Final yield should be calculated at the end of the manufacturing that should not be less than 99.00%. 7 . Abbreviations: list of the abbreviation used in the document should be made to understand the BMR easily.

9. Conti… 8 . History of changes : At the end the document should have a list of the changes in the document including the revision no. and date of change.

10. BATCH MANUFACTURING RECO R D