Standard Operating Procedure for Batch Documentation Approval in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/129/2025
Supersedes	SOP/BS/129/2022
Page No.	Page 1 of 11
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To establish a consistent and GMP-compliant procedure for reviewing, verifying, and approving batch production and control records prior to batch release in biosimilar manufacturing.

2. Scope

This SOP applies to all manufacturing, packaging, in-process, and quality control records associated with a biosimilar batch from raw material dispensing through product release.

3. Responsibilities

• Production: Complete batch records in real-time, ensuring legibility and accuracy.
• QC: Attach all supporting analytical records and results.
• QA: Review, verify, and approve all entries and calculations prior to batch disposition.

4. Accountability

The Head of Quality Assurance is accountable for ensuring that no batch is released without thorough documentation review and compliance with regulatory standards.

5. Procedure

5.1 Collection of Batch Records

1. At the end of each manufacturing step, production shall collect and compile all filled documents, including:
   • Batch Manufacturing Record (BMR)
   • Equipment Cleaning and Usage Logs
   • Material Issuance Records
   • Deviations, if any

5.2 Quality Control Attachments

1. QC will provide:
   • In-process testing results
   • Final product CoA
   • Environmental monitoring data
2. QC shall ensure results are traceable to raw data and equipment IDs.

5.3 QA Review Checklist

1. QA shall verify:
   • Each entry is filled, signed, and dated
   • Corrections are justified and signed
   • Yields are within specified range
   • All critical process parameters are within range
   • Deviations and CAPAs are closed (if applicable)
2. Record review remarks in Annexure-1: QA Batch Review Form.

5.4 Final Approval and Archiving

1. QA Manager or designee shall sign the final page of BMR with “Approved” status.
2. Approved batch records shall be archived for a minimum of 5 years in a controlled documentation room.
3. Record archiving in Annexure-2: Batch Archival Register.

5.5 Handling of Errors or Omissions

1. QA shall issue a Documentation Error Note (DEN) if missing entries are found.
2. Operator and supervisor shall correct the record with dated signature and justification.
3. DENs shall be recorded in Annexure-3.

6. Abbreviations

• BMR: Batch Manufacturing Record
• CoA: Certificate of Analysis
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance

7. Documents

1. QA Batch Review Form – Annexure-1
2. Batch Archival Register – Annexure-2
3. Documentation Error Note Log – Annexure-3

8. References

• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals
• ICH Q10 – Pharmaceutical Quality System
• WHO TRS 986 – Annex 2: GMP for Biologics

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: QA Batch Review Form

Batch No.	Review Date	Reviewed By	Observations	Status
BS-MFG-017	04/05/2025	Sunita Reddy	Complete	Approved

Annexure-2: Batch Archival Register

Batch No.	Approval Date	Archive Location	Archived By
BS-MFG-017	04/05/2025	Cabinet 2, Shelf B	Ajay Verma

Annexure-3: Documentation Error Note Log

DEN No.	Batch No.	Description	Corrected By	Date
DEN/2025/004	BS-MFG-017	Missing signature on yield calculation	Rajesh Kumar	03/05/2025

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Added documentation error handling section and QA checklist	Internal Audit Observation