Standard Operating Procedure for Use of Raw Materials in GMP Batches in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/146/2025
Supersedes	SOP/BS/146/2022
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 the qualification, handling, approval, and traceable usage of raw materials in GMP batches used in the biosimilar manufacturing process, ensuring regulatory compliance and product quality.

2. Scope

This SOP applies to all raw materials including media components, salts, buffers, and excipients used in GMP-grade biosimilar batches within the manufacturing facility.

3. Responsibilities

• Warehouse: Receive, store, and issue approved raw materials with appropriate labeling and documentation.
• QC: Sample and test each material against specifications.
• QA: Review COA, approve raw material release, and monitor traceability.
• Production: Use only released materials, verify lot numbers, and record usage in batch records.

4. Accountability

The QA Head is accountable for the approval and traceability of raw materials in GMP production batches and ensuring their use complies with approved procedures and specifications.

5. Procedure

5.1 Raw Material Receipt and Sampling

1. Receive raw materials with invoice, COA, and MSDS at warehouse receiving bay.
2. Assign internal material code and quarantine status label.
3. QC to sample material under controlled conditions and document in Annexure-1: Sampling Log.

5.2 Material Testing and Approval

1. QC to perform tests including:
   • Identity (IR, NMR, TLC)
   • Purity and assay
   • pH and appearance
   • Microbial limits (if applicable)
2. QA reviews results and releases the material with “Approved” status label and assigns release number.

5.3 Material Dispensing and Traceability

1. Materials for GMP batches to be dispensed in classified areas under LAF units.
2. Record each dispensation in Annexure-2: Material Dispensing Log, capturing:
   • Batch number
   • Material code and name
   • Quantity dispensed
   • Lot number
   • Person dispensing
3. Weighing equipment must be calibrated and cleaned before use.

5.4 Usage in Production

1. Production to verify the material label, status, lot number, and expiry before use.
2. Cross-check against the BMR (Batch Manufacturing Record).
3. Record actual quantity used and reconcile with dispensed quantity.

5.5 Material Rejection or Deviation Handling

1. Any material found out of specification shall be quarantined and investigated by QA.
2. Rejection must be documented in Annexure-3: Rejected Material Log.

5.6 Storage and Expiry Monitoring

1. All materials to be stored as per label conditions (e.g., RT, 2–8°C, desiccated).
2. Warehouse to maintain Annexure-4: Material Expiry Monitoring Log and alert QA 30 days before expiry.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record
• LAF: Laminar Air Flow

7. Documents

1. Sampling Log – Annexure-1
2. Material Dispensing Log – Annexure-2
3. Rejected Material Log – Annexure-3
4. Material Expiry Monitoring Log – Annexure-4

8. References

• EU GMP Part I – Chapter 5: Production
• WHO TRS 986 – Annex 2: GMP for Biologics
• ICH Q7 – GMP for Active Pharmaceutical Ingredients

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sampling Log

Date	Material Name	Code	Batch No.	Sampled By	Container Count
02/05/2025	Sodium Bicarbonate	RM-091	SB-50025	Ajay Verma	4

Annexure-2: Material Dispensing Log

Date	Batch No.	Material	Code	Qty	Lot No.	Dispensed By
03/05/2025	BS-UP-097	Glucose Monohydrate	RM-112	1.0 kg	GM-7782	Sunita Reddy

Annexure-3: Rejected Material Log

Date	Material	Code	Reason	Rejected By
01/05/2025	Sodium Chloride	RM-102	pH out of range	QA Officer

Annexure-4: Material Expiry Monitoring Log

Material	Lot No.	Expiry Date	Alert Sent	Action Taken
L-Glutamine	LG-2098	15/06/2025	15/05/2025	To be used by 10/06/2025

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Expanded traceability and expiry control procedures	GMP Compliance Enhancement