Procedure for Preparing Batch Manufacturing Records

Department	Production/Quality Assurance (QA)
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

This Standard Operating Procedure (SOP) defines the process for preparing Batch Manufacturing Records (BMR) to ensure accurate, compliant, and traceable documentation of pharmaceutical manufacturing activities. BMRs serve as a legal and regulatory document to verify adherence to Good Manufacturing Practices (GMP), ensure consistency in production, and facilitate traceability in case of deviations or recalls.

2. Scope

This SOP applies to personnel responsible for the preparation, verification, and approval of Batch Manufacturing Records (BMR) in the Production and Quality Assurance (QA) departments.

3. Responsibilities

• Production Officer: Prepares batch documentation as per standard procedures.
• Production Supervisor: Reviews completed BMRs for accuracy and completeness.
• QA Officer: Cross-verifies data entries for compliance.
• QA Manager: Reviews and approves BMRs before final archiving.

4. Accountability

The QA and Production Managers are accountable for ensuring all BMRs are correctly prepared and maintained in compliance with GMP, FDA, ICH, and WHO standards.

5. Procedure

5.1 Components of a Batch Manufacturing Record

Each BMR must contain the following sections:

• Batch Identification: Product name, batch number, manufacturing and expiry date.
• Raw Materials: List of ingredients, lot numbers, supplier details, and material specifications.
• Manufacturing Process: Stepwise procedures, process parameters, and mixing times.
• Equipment Used: Identification numbers, calibration details, and cleaning records.
• In-Process Control (IPC) Checks: Parameters like temperature, viscosity, and pH.
• Yield Calculation: Theoretical vs. actual yield with justification for deviations.
• Cleaning and Line Clearance: Documentation of area and equipment cleaning before processing.
• Final Product Analysis: Laboratory test results, specification compliance, and QA approval.

5.2 Preparation of the BMR

• The Production Officer must obtain the approved BMR template from QA.
• Batch-specific details must be accurately recorded, including:
  • Batch number, product name, and batch size.
  • Raw materials, supplier details, and lot numbers.
  • Manufacturing conditions, including temperature, pressure, and processing times.
• All details must be recorded **contemporaneously** in **indelible ink**.
• Cross-check each entry against the Master Manufacturing Formula (MMF).
• Ensure proper **documentation of deviations** with approved justifications.

5.3 Data Entry and Documentation Standards

• Follow ALCOA+ principles for data integrity:
  • Attributable: Each entry must be signed and dated.
  • Legible: Ensure all handwriting is clear and readable.
  • Contemporaneous: Record entries in real-time.
  • Original: Use official BMR templates and avoid photocopies.
  • Accurate: Ensure data correctness and avoid alterations.
• Corrections should be handled by:
  • Striking through errors with a single line.
  • Writing the correct information next to the incorrect entry.
  • Initialing and dating corrections.
  • Providing justification if necessary.

5.4 Verification and Approval Process

• The Production Supervisor must verify all recorded details.
• QA must conduct a cross-check for:
  • Completeness and accuracy of batch details.
  • Consistency with the Master Manufacturing Formula (MMF).
  • Proper documentation of any deviations.
• The final BMR must be signed by:
  • Production Officer
  • QA Officer
  • Authorized Signatory

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)
• BMR Verification Log (Annexure-2)

8. References

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

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

12. Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/02/2025	2.0	Updated Format	Improved Documentation Practices	QA Head