SOP On Issuance and Submission of Batch Manufacturing Record (BMR)

SOP On Issuance and Submission of Batch Manufacturing Record (BMR)

Objective: To lay down the procedure for the issuance and submission of batch manufacturing records (BMR).

Scope: This SOP shall apply for the issuance and submission of batch manufacturing records (BMR) to Production in the Formulation plant.

Responsibility

Production personnel shall be responsible for giving requisition for issuance of BMR as per production plan. After batch completion completed BMR shall be submitted to QA.

QA personnel shall be responsible for issuance and receiving of BMR. 

Accountability

Head – Production & Head – QA shall be accountable for implementation of this SOP.

Abbreviations and Definitions

  • BMR : Batch Manufacturing Record
  • No.   : Number
  • Mfg. :  Manufacturing
  • Exp. :  Expiry

Procedure

Issuance

It is based on production planning, Head-Production shall decide the number of batches of a product to be produced in the month.

Production personnel shall raise the requisition for the issuance of BMRs for the batches to be taken & forward it to QA.

On receipt of requisition, QA person shall verify the details entered in the requisition form.

Production supervisor shall enter the batch details like Department Code, S. No. , BMR issue date, Name of Product, Batch No., Batch Size, Mfg. Date, Exp. Date, M.R.P. Supply and Requisition No. details in the BMR Issuance and Submission Record .

A photocopy of the required master batch manufacturing record shall be taken and issued to Production. All pages of the photocopied sheet of BMR shall be signed and dated by QA.

Insert the signed BMR in a file and enter the details such as BMR No., Product Name, Unit Size, Batch No., Batch Size, Mfg. Date, Exp. Date & Supply on front of the file.

Before issuance each BMR shall be numbered.

BMR numbering system shall consist of 13 alphanumeric characters i.e. D-NNN/XXXX-YY.

Where, D denotes department code (e.g. OL for Oral Liquid and so on). For details of department codes refer SOP : SOP on SOP.

‘-’ denotes dash.

NNN denotes serial number viz. 001, 002, 003 and so on.

‘/’ denotes forward slash.

XXXX-YY denotes financial year viz. 2022-23 for the financial year 2022 to 2023.

The complete file shall be issued to production by QA and details shall be recorded in BMR Issuance & Submission Record.

Submission

After batch completion the completely reviewed BMR shall be submitted to QA.

In case of cancellation due to change in production planning or by any other reasons, the issued BMR shall be returned to QA  and the same shall be recorded in Remark column of BMR Issuance and Submission Record.

Forms and Records (Annexures)

Not Applicable

Distribution

Master copy  –  Quality Assurance

Controlled copies – Quality Assurance, Production

History:

Date Revision Number
               Reason for Revision
00
               New SOP

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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