Standard Operating Procedure for Record Keeping for Cell Line Development in Biosimilars
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/038/2025 |
| Supersedes | SOP/BS/038/2022 |
| Page No. | Page 1 of 13 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To establish a standardized procedure for record keeping and documentation during cell line development (CLD) for biosimilars to ensure traceability, reproducibility, and regulatory compliance in line with GMP and data integrity principles.
2. Scope
This SOP applies to all laboratory notebooks, digital records, clone tracking systems, and associated documents generated during the development and qualification of biosimilar-producing cell lines.
3. Responsibilities
- Cell Line Development Scientist: Maintains detailed records of experiments, observations, and results.
- Document Controller: Archives physical and electronic records, assigns document numbers, and tracks revisions.
- QA Officer: Ensures all records are reviewed, verified, and maintained in compliance with ALCOA+ principles.
4. Accountability
The Head of Quality Assurance is accountable for ensuring that all records associated with cell line development are properly maintained, secured, and available for audits and regulatory inspections.
5. Procedure
5.1 Documentation Standards
- Use bound laboratory notebooks or validated electronic systems.
- All entries must be:
- Made in indelible ink (for paper records)
- Dated and signed by the originator
- Not corrected using erasers or white-out
5.2 Required Records During CLD
- Gene Construct Documentation: Vector maps, gene sequence files, restriction enzyme sites
- Transfection/Transformation Logs: Date, method used, cell line, media, antibiotics
- Clone Screening Records: ELISA/SDS-PAGE results, viability, productivity (Annexure-1)
- Stability Studies: Passage tracking, copy number, titer results
- GMO Handling Records: Risk category, biosafety log
- Cell Bank Creation Reports: MCB/WCB preparation, storage temperature, vials, location
5.3 Data Integrity Requirements (ALCOA+)
- Ensure all data is:
- Attributable: Identifiable by originator
- Legible: Clear and readable
- Contemporaneous: Recorded at the time of activity
- Original: First generation record
- Accurate: Free from error
- + Complete, Consistent, Enduring, and Available
5.4 Version Control
- All templates and logs must have version numbers and revision dates.
- Previous versions to be archived and marked as “Obsolete.”
5.5 Archival and Retention
- Records must be stored in a secure, access-controlled facility or server.
- Retention period: Minimum of 10 years from the end of CLD project or product discontinuation, whichever is longer.
5.6 Audit Preparedness
- Conduct quarterly internal audits of documentation practices.
- Maintain the CLD Documentation Audit Log (Annexure-2).
6. Abbreviations
- CLD: Cell Line Development
- ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate, +Complete, Consistent, Enduring, Available
- QA: Quality Assurance
- MCB/WCB: Master/Working Cell Bank
7. Documents
- Clone Screening Summary Log (Annexure-1)
- CLD Documentation Audit Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- FDA Data Integrity Guidance (2018)
- WHO Annex 5 – Guidelines on 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: Clone Screening Summary Log
| Date | Clone ID | Method | Viability (%) | Titer (g/L) | Remarks | Scientist |
|---|---|---|---|---|---|---|
| 03/05/2025 | C-038-A1 | ELISA | 92 | 1.08 | Selected | Sunita Reddy |
Annexure-2: CLD Documentation Audit Log
| Date | Auditor | Audit Area | Observations | Corrective Action | Status |
|---|---|---|---|---|---|
| 01/05/2025 | Rajesh Kumar | Notebook Entries | One entry without signature | Training refresher | Closed |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Included ALCOA+ principles and electronic record compliance | Audit and regulatory alignment |