Standard Operating Procedure for Tracking Consumables in Bioreactor Runs in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/116/2025
Supersedes	SOP/BS/116/2022
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 the procedure for documenting, labeling, and verifying all consumables used during bioreactor runs in biosimilar upstream processing, ensuring traceability, quality control, and regulatory compliance.

2. Scope

This SOP applies to all single-use and reusable consumables such as filters, bags, tubing, gaskets, sensors, clamps, and sampling devices used during bioreactor preparation, inoculation, cultivation, and harvest operations in the upstream biosimilar facility.

3. Responsibilities

• Production Operator: Record lot numbers and quantities of all consumables used.
• Warehouse: Ensure only approved and released materials are issued.
• QA: Verify reconciliation and traceability of consumables in the batch record.

4. Accountability

The Head of Production is accountable for ensuring consumable usage is traceable and properly documented for every bioreactor batch.

5. Procedure

5.1 Consumable Issuance

1. Raise a requisition using internal request form (Annexure-1) specifying batch, bioreactor ID, and expected consumables.
2. Warehouse issues items from approved stock, noting:
   • Item name
   • Part number
   • Lot number
   • Quantity
3. Transfer issued materials to staging area in labeled transport containers.

5.2 Pre-Use Verification

1. Operators to inspect and verify:
   • Packaging integrity
   • Labeling and lot no. against request
   • Expiry date and status of approval
2. Record verifications in Annexure-2: Consumable Usage Log.

5.3 During Bioreactor Run

1. Affix a color-coded tag or barcode to tubing sets, filters, bags after assembly.
2. Record usage point (e.g., harvest line, feed port) in bioreactor checklist.
3. Mark partial use of any item and transfer balance to labeled return bin.

5.4 Post-Run Reconciliation

1. Cross-check used vs. issued quantity using Annexure-3.
2. Return unopened consumables to warehouse with “Return to Stock” label.
3. Dispose used consumables via bio-waste process; log in disposal section of Annexure-2.

5.5 Documentation and Review

1. Submit complete records with batch manufacturing file for QA review.
2. QA to verify consistency and completeness before batch release.

6. Abbreviations

• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• ID: Identification

7. Documents

1. Consumable Requisition Form – Annexure-1
2. Consumable Usage Log – Annexure-2
3. Reconciliation Report – Annexure-3

8. References

• WHO TRS 1003 – GMP for Biologics
• EU GMP Part I and II – Traceability and Documentation Requirements

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Consumable Requisition Form

Batch No.	Bioreactor ID	Item	Part No.	Qty	Requested By
BS-P001	BR-200L	pH Probe	PH4500	2	Sunita Reddy

Annexure-2: Consumable Usage Log

Date	Item	Lot No.	Used Qty	Remaining	Disposed	Operator
04/05/2025	0.2µm Filter	F3821	1	0	Yes	Ajay Verma

Annexure-3: Reconciliation Report

Item	Issued	Used	Returned	Disposed	Verified By
Sampling Bag	10	8	2	0	QA Officer

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Expanded to include barcoding and reconciliation log	System improvement