Standard Operating Procedure for Raw Data Archival and Review in Biosimilar Upstream Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/104/2025
Supersedes	SOP/BS/104/2022
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 procedure for the collection, archival, retrieval, and review of raw data generated during upstream biosimilar production activities, ensuring compliance with regulatory requirements and internal policies on data integrity.

2. Scope

This SOP covers all raw data generated in upstream operations including electronic data, handwritten logs, instrument printouts, and system-generated reports within the biosimilars manufacturing department.

3. Responsibilities

• Operator: Ensure proper recording, labeling, and timely submission of raw data to the designated archival authority.
• Supervisor: Review completeness and consistency of raw data entries prior to batch record submission.
• QA: Perform periodic audits of archived raw data and approve retention and retrieval practices.

4. Accountability

The Head of QA is accountable for ensuring proper governance, retention, and compliance of raw data handling and archival in accordance with cGMP and data integrity standards.

5. Procedure

5.1 Types of Raw Data

1. Raw data includes but is not limited to:
   • Bioreactor logs (pH, DO, temp, RPM)
   • Media and buffer preparation records
   • Electronic batch records (EBR)
   • Printouts from SCADA, sensors, balances
   • Analytical test records (e.g., osmolality, VCD)

5.2 Data Collection and Labeling

1. All raw data must be collected in real-time and labeled with:
   • Batch number
   • Date and time
   • Instrument ID (if applicable)
   • Operator initials
2. Use black or blue ink for manual records; no overwriting is permitted.

5.3 Review of Raw Data

1. Supervisors must review raw data for:
   • Completeness and legibility
   • Consistency with EBR entries
   • Any unexplained gaps or corrections
2. Review comments must be documented and dated.

5.4 Archival of Raw Data

1. Submit all reviewed raw data to QA within 2 working days after batch completion.
2. QA shall archive:
   • Paper records in labeled batch folders in secured fireproof cabinets
   • Electronic records on validated servers with version control
3. Annexure-1: Raw Data Archival Log must be updated accordingly.

5.5 Retrieval and Retention

1. All archived raw data must be retrievable within 24 hours upon request.
2. Minimum retention period:
   • Commercial batches: 7 years
   • Clinical batches: 15 years or as per protocol

5.6 Audit Trail and Data Integrity Compliance

1. For electronic records, ensure audit trails are enabled, secure, and reviewable.
2. All data must meet ALCOA+ principles:
   • Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available

6. Abbreviations

• ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, + Complete, Consistent, Enduring, Available
• QA: Quality Assurance
• EBR: Electronic Batch Record

7. Documents

1. Raw Data Archival Log – Annexure-1
2. Data Review Checklist – Annexure-2

8. References

• WHO TRS 1019 – Annex 1 (GMP for Biological Products)
• MHRA Guidance on GxP Data Integrity

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Data Archival Log

Date	Batch No.	Data Type	Format	Archived By	Location
04/05/2025	BS-BT-018	Bioreactor Printouts	Paper	Sunita Reddy	Cabinet 3B

Annexure-2: Data Review Checklist

Record Type	Reviewed By	Date	Gaps Observed	Corrective Action Required
Seed Train Log	Ajay Verma	04/05/2025	None	NA

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Added ALCOA+ principles and Annexure-2 for QA checklist	Data governance enhancement