Standard Operating Procedure for Harmonizing MCB/WCB Data with QA System in Biosimilar Development

Department	Biosimilars
SOP No.	SOP/BS/052/2025
Supersedes	SOP/BS/052/2022
Page No.	Page 1 of 10
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define the procedure for harmonizing Master Cell Bank (MCB) and Working Cell Bank (WCB) data with Quality Assurance (QA) systems in biosimilar development, ensuring consistent documentation, traceability, and GMP compliance.

2. Scope

This SOP applies to all data related to the creation, characterization, testing, and archival of MCB and WCB records, and the processes for integration with QA-managed documentation systems.

3. Responsibilities

• CLD Team: Generates, maintains, and updates MCB/WCB documentation in alignment with lab records.
• QA Department: Verifies completeness and accuracy of MCB/WCB data; integrates into official QA-controlled systems.
• Head of Biosimilars: Ensures procedural adherence and final approval of harmonized records.

4. Accountability

The Head of QA is accountable for ensuring that all MCB and WCB records are harmonized, traceable, and ready for internal or external audits as per regulatory standards.

5. Procedure

5.1 Creation of MCB/WCB Documentation Set

1. Ensure the following documents are compiled post-banking:
   • Cell Bank Production Report
   • Analytical Test Results (e.g., sterility, mycoplasma, identity)
   • Cryopreservation Protocol
   • Storage Location Map

5.2 Internal Record Verification

1. Cross-verify:
   • Banking date and passage number
   • Freezer ID and vial labeling
   • Test results and equipment calibration logs
2. Document verification outcomes in the Record Reconciliation Sheet (Annexure-1).

5.3 QA Review and Integration

1. Submit verified records to QA for master file integration.
2. QA to assign QA Document ID and enter into QA Register (Annexure-2).
3. Files to be indexed with electronic and physical folder names clearly labeled.

5.4 Discrepancy Resolution

1. Any mismatch between lab data and QA entries must trigger a controlled deviation.
2. Deviation must be closed prior to final approval by QA.

5.5 Archival and Audit Readiness

1. Store harmonized documentation in QA-controlled archives.
2. Backup electronic files on secure QA server with restricted access.
3. Review completeness during annual GMP internal audit.

6. Abbreviations

• MCB: Master Cell Bank
• WCB: Working Cell Bank
• CLD: Cell Line Development
• QA: Quality Assurance
• GMP: Good Manufacturing Practice

7. Documents

1. Record Reconciliation Sheet (Annexure-1)
2. QA Cell Bank Integration Register (Annexure-2)

8. References

• ICH Q5D – Derivation and Characterization of Cell Substrates
• WHO Technical Report Series 978 – Annex 3
• 21 CFR Part 211 – Subpart J: Records and Reports

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Record Reconciliation Sheet

Record Type	CLD Entry	QA Entry	Verified By	Date
Banking Date	28/04/2025	28/04/2025	Ajay Verma	01/05/2025

Annexure-2: QA Cell Bank Integration Register

QA Doc ID	Cell Bank ID	CLD File Ref	Entry Date	Integrated By
QA-MCB-042	MCB-CHO-017	CLD-MCB-017	01/05/2025	Sunita Reddy

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Integrated QA documentation workflow and reconciliation protocol	Process Standardization