Standard Operating Procedure for Material Traceability in Upstream Operations in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/134/2025
Supersedes	SOP/BS/134/2022
Page No.	Page 1 of 11
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define a standard procedure for ensuring complete traceability of all materials used in upstream processes during biosimilar manufacturing, from raw material receipt to final usage, in compliance with GMP guidelines.

2. Scope

This SOP applies to the warehouse, production, and quality assurance departments involved in the receipt, storage, issuance, and usage of materials such as media, buffers, supplements, and reagents in upstream biosimilar operations.

3. Responsibilities

• Warehouse: Ensure materials are received, labeled, and stored with unique codes.
• Production: Record issuance and usage of materials against specific batch numbers.
• QA: Audit material records and approve traceability documentation.

4. Accountability

The Head of QA is accountable for ensuring that material traceability is maintained, reviewed, and auditable for all upstream manufacturing activities.

5. Procedure

5.1 Receipt and Labeling

1. Upon receipt, warehouse staff shall:
   • Verify material name, quantity, supplier details, and CoA.
   • Assign a unique internal receipt number (e.g., RM-2025-045).
   • Affix material status label (Quarantine/Approved/Rejected).
2. Record details in Annexure-1: Material Receipt Log.

5.2 Storage and Dispensing

1. Store approved materials in designated temperature-controlled areas.
2. Issue materials to production only against approved batch manufacturing records (BMR).
3. Record quantity issued, lot number, and operator initials in Annexure-2: Material Issuance Log.

5.3 Usage Documentation

1. Production staff shall:
   • Record actual quantity used, time, and stage of process (e.g., media prep, feeding).
   • Use barcode/RFID system (if implemented) to log usage.
   • Cross-check with balance records to avoid duplication or omission.
2. QA to verify usage against planned requirements.

5.4 Traceability Verification

1. QA shall perform periodic traceability checks:
   • Backward: From usage back to receipt
   • Forward: From material receipt to all batches it was used in
2. Use Annexure-3: Traceability Mapping Sheet to capture review outcomes.

5.5 Deviations and Reconciliation

1. Any discrepancy in usage, excess consumption, or material swap must be reported using deviation management system.
2. Reconciliation must be completed post-batch and signed by Production and QA.

6. Abbreviations

• BMR: Batch Manufacturing Record
• CoA: Certificate of Analysis
• QA: Quality Assurance
• GMP: Good Manufacturing Practice

7. Documents

1. Material Receipt Log – Annexure-1
2. Material Issuance Log – Annexure-2
3. Traceability Mapping Sheet – Annexure-3

8. References

• 21 CFR Part 211 – Subpart E: Control of Components and Drug Product Containers and Closures
• EU GMP Chapter 5 – Production
• 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: Material Receipt Log

Date	Material Name	Vendor	Lot No.	Qty	Label No.
04/05/2025	CHO Feed A	Thermo Fisher	TF-4587	25 kg	RM-2025-045

Annexure-2: Material Issuance Log

Date	Batch No.	Material	Issued Qty	Used By
04/05/2025	BS-UP-078	CHO Feed A	12 kg	Ajay Verma

Annexure-3: Traceability Mapping Sheet

Material	Receipt ID	Batch Used In	Qty Used	Verified By
CHO Feed A	RM-2025-045	BS-UP-078	12 kg	Sunita Reddy

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Barcode and deviation handling added	Audit Compliance