BMR (Batch Manufacturing Record) & BPR (Batch Packing Record)

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BMR (Batch Manufacturing Record) is one of the key document in pharmaceutical. It is a record or history for every batch manufactured in pharmaceuticals.

BMR is called as by followings too:

  • BPR-Batch processing record
  • BPCR -Batch processing & control record
  • BMR with BPR-Batch manufacturing & Batch packaging record e.t.c

Batch manufacturing & batch packaging record is itself a documentary for a particular product manufacturing in pharmaceutical plant which have a sequential data recording along with facility, utility and product parameters.

Preparation of Batch manufacturing & batch packaging record: 

  • Batch manufacturing & batch packaging record shall prepared for each product or by following suitability, in easy language we can say each product have their own BMR.
  • BMR & BPR is prepared by user, and user is production personnel. prepared by production personnel and than shall checked by production head and after that reviewed by QA. BMR & BPR shall prepared by following step of master formula record given by R&D (research & development) or PDD (Product development department).
  • After reviewed by QA final print of BMR shall taken out by QA, and all related signature shall be done .
  • Signed copy stamped by master copy stamp in a designated place in BMR and then kept in lock and key by QA.
  • Master copy shall photocopied after getting BMR & BPR requisition by production department. Photocopied BMR shall stamped by controlled copy and same shall be send to production.
  • Issuance of BMR & BPR shall maintain in a issuance register and receiving shall be taken by production personnel as a proof of issuance.

Usage of Batch manufacturing & batch packaging record: 

  • Production personnel shall start to write on the same from when they shall start dispensing of that particular product.
  • All stages recording from starting to end, dispensing to dispatch should cover in BMR & BPR.
  • All related personnel shall sign off after doing data recording including IPQA, each stage verification and line clearance shall denotes the product progress.
  • When a step completed practically in shop floor that should be also finished in BMR. Online filling of BMR & BPR is must.
  • One stage completing product and BMR shall transfer to next stage, before line clearance production personnel and IPQA shall ensure the completeness of previous step.
  • In case of discrepancy in last step of production, production shall stopped and should start after rectification of same.
  • At stage of packing product’s final analysis-Finished goods analysis shall completed by QC, and then complete BMR shall reviewed by QA before final release of product.
  • After final review if everything is clear and correct than QA shall release the finished product and BMR shall close for the same.
  • Closed BMR & BPR shall deposit in document cell in QA.
  • A log for deposition of all BMR & BPR shall maintained by Documentation cell in-charge in QA.
  • In case, review of previous batch to be done, issuance of previous BMR shall too log in Deposition register.
  • After completion of retention period i.e. 5 years or product expiry plus one whatever is greater (as per WHO), destruction of BMR & BPR shall be done by following destruction policy of organization and record shall maintained accordingly,
  • Destruction shall be done by QA.

 

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