Procedure for Preparing Batch Manufacturing Records

Department	Quality Assurance (QA)/Production
SOP No.	SOP/Ointment/151
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for preparing Batch Manufacturing Records (BMR) in pharmaceutical manufacturing. Proper documentation ensures compliance with Good Manufacturing Practices (GMP), facilitates traceability, and maintains consistency in manufacturing processes.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA) and Production departments involved in preparing, reviewing, and maintaining Batch Manufacturing Records (BMR) for ointment production.

3. Responsibilities

• Production Officer: Ensures accurate data entry in the BMR.
• Production Supervisor: Reviews BMR entries for completeness and compliance.
• QA Officer: Cross-verifies records and approves BMR documentation.
• QA Manager: Ensures BMR meets regulatory standards before archiving.

4. Accountability

The QA and Production Managers are accountable for ensuring that BMR preparation complies with GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Components of a Batch Manufacturing Record

A BMR must include the following sections:

• Batch Details: Batch number, manufacturing date, expiry date.
• Manufacturing Instructions: Stepwise process details.
• Raw Material and Component List: Weighed quantities and supplier details.
• In-Process Control Data: Critical process parameters (e.g., temperature, pressure).
• Equipment and Cleaning Records: Details of equipment used and cleaning verification.
• Yield Calculation: Theoretical vs. actual yield analysis.
• Final Product Testing: Analytical data and quality approval.

5.2 Preparation of the BMR

• Obtain an approved BMR template from the QA department.
• Ensure all details are filled in as per the Master Manufacturing Formula (MMF).
• Record batch-specific information such as:
  • Batch size and formulation components.
  • Manufacturing start and completion dates.
  • Lot numbers of raw materials used.

5.3 Documentation Standards

• All entries must be made in indelible ink.
• Corrections should be signed, dated, and justified.
• Ensure all data entries follow ALCOA+ principles:
  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate

5.4 Verification and Approval Process

• The production supervisor must verify BMR details for accuracy.
• QA must review and cross-check all recorded data.
• The BMR must be signed by:
  • Production Officer
  • QA Officer
  • Authorized Signatory

5.5 Archiving of BMR

• Once approved, the BMR should be archived securely.
• Retention period must comply with regulatory guidelines (minimum of 5 years).
• Ensure easy retrieval for audits and inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• BMR – Batch Manufacturing Record
• MMF – Master Manufacturing Formula
• FDA – Food and Drug Administration
• ICH – International Council for Harmonisation

7. Documents

• Batch Manufacturing Record Template (Annexure-1)
• Batch Manufacturing Record Review Log (Annexure-2)

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines for Pharmaceutical Documentation
• US FDA Guidance on Batch Documentation

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Batch Manufacturing Record Template

Batch No.	Manufacturing Date	Expiry Date	Product Name	Batch Size
OINT-1001	01/02/2025	01/02/2027	Ointment A	100 kg
OINT-1002	02/02/2025	02/02/2027	Ointment B	200 kg

Annexure-2: Batch Manufacturing Record Review Log

Date	Batch No.	Reviewed By	Approval Status	Remarks
01/02/2025	OINT-1001	QA Manager	Approved	N/A
02/02/2025	OINT-1002	QA Manager	Approved	N/A