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
- Receive raw materials with invoice, COA, and MSDS at warehouse receiving bay.
- Assign internal material code and quarantine status label.
- QC to sample material under controlled conditions and document in Annexure-1: Sampling Log.
5.2 Material Testing and Approval
- QC to perform tests including:
- Identity (IR, NMR, TLC)
- Purity and assay
- pH and appearance
- Microbial limits (if applicable)
- QA reviews results and releases the material with “Approved” status label and assigns release number.
5.3 Material Dispensing and Traceability
- Materials for GMP batches to be dispensed in classified areas under LAF units.
- Record each dispensation in Annexure-2: Material Dispensing Log, capturing:
- Batch number
- Material code and name
- Quantity dispensed
- Lot number
- Person dispensing
- Weighing equipment must be calibrated and cleaned before use.
5.4 Usage in Production
- Production to verify the material label, status, lot number, and expiry before use.
- Cross-check against the BMR (Batch Manufacturing Record).
- Record actual quantity used and reconcile with dispensed quantity.
5.5 Material Rejection or Deviation Handling
- Any material found out of specification shall be quarantined and investigated by QA.
- Rejection must be documented in Annexure-3: Rejected Material Log.
5.6 Storage and Expiry Monitoring
- All materials to be stored as per label conditions (e.g., RT, 2–8°C, desiccated).
- 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
- Sampling Log – Annexure-1
- Material Dispensing Log – Annexure-2
- Rejected Material Log – Annexure-3
- 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 |