Standard Operating Procedure for Storage of Purified Bulk Product in Biosimilar Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/191/2025 |
| Supersedes | SOP/BS/191/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To define a GMP-compliant procedure for the proper storage of biosimilar purified bulk drug substance (BDS) including labeling, temperature control, documentation, and transfer for further processing or fill-finish operations.
2. Scope
This SOP applies to all batches of biosimilar drug substance that have completed downstream purification and are ready for temporary storage in controlled environments pending release or filling.
3. Responsibilities
- Production: Label, transfer, and store purified bulk in designated areas under controlled conditions.
- Warehouse: Monitor temperature and maintain logbooks of storage units.
- QA: Verify labeling, quarantine status, and approve release from storage.
- QC: Perform hold-time stability sampling if applicable.
4. Accountability
The Head of Manufacturing and Head of Quality Assurance are jointly accountable for ensuring proper storage and traceability of purified bulk material prior to final drug product manufacturing.
5. Procedure
5.1 Transfer from DSP to Storage
- Ensure purified bulk has passed all in-process checks (e.g., pH, bioburden, conductivity).
- Transfer bulk in pre-cleaned and validated stainless steel or single-use containers as per batch record.
- Seal containers with tamper-evident ties and label as per Section 5.2.
5.2 Labeling of Bulk Containers
- Apply GMP-compliant label with following details:
- Product name
- Batch number
- Quantity/volume
- Storage temperature range
- Status: Quarantine / Released
- Date and time of storage
- Labels must be water-resistant, legible, and affixed securely.
5.3 Storage Conditions
- Store bulk in designated refrigerated chamber at 2–8°C or per product-specific conditions.
- Place on validated stainless steel racks or pallet systems avoiding direct contact with walls or floor.
- Environmental conditions must be monitored with calibrated sensors and auto-alarms.
- Log temperature every 30 minutes using electronic data logger (Annexure-1).
5.4 Quarantine and Hold Duration
- Place bulk under “QUARANTINE” status until QA batch release is completed.
- Do not use for filling or formulation until QA provides written release.
- If storage exceeds hold-time limit defined in the stability protocol, raise a deviation.
5.5 Transfer to Fill-Finish or Formulation
- Release transfer initiated only upon QA clearance.
- Transfer must follow cold-chain handling SOP (refer SOP/BS/192/2025).
- Document transfer time, personnel, and destination (Annexure-2).
5.6 Deviation Management
- Any deviation in storage conditions, labeling error, or temperature excursion must be recorded and investigated.
- Document deviation in Annexure-3 and report to QA within 2 hours.
6. Abbreviations
- BDS: Bulk Drug Substance
- QA: Quality Assurance
- QC: Quality Control
- GMP: Good Manufacturing Practice
7. Documents
- Bulk Storage Temperature Log – Annexure-1
- Bulk Transfer Record – Annexure-2
- Storage Deviation Form – Annexure-3
8. References
- ICH Q5C – Stability Testing of Biotechnological/Biological Products
- WHO GMP for Biotherapeutic Products
- FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Bulk Storage Temperature Log
| Date | Time | Chamber ID | Recorded Temp (°C) | Checked By |
|---|---|---|---|---|
| 04/05/2025 | 09:00 | RCH-02 | 5.2 | Ajay Verma |
Annexure-2: Bulk Transfer Record
| Date | Batch No. | Transfer From | To | Temp Maintained | Personnel |
|---|---|---|---|---|---|
| 04/05/2025 | BS-BULK-051 | Cold Room RCH-02 | Fill-Finish Area | 4°C | Sunita Reddy |
Annexure-3: Storage Deviation Form
| Date | Deviation Type | Description | Corrective Action | Reported By |
|---|---|---|---|---|
| 03/05/2025 | Temperature Excursion | 6°C for 1 hr | Reviewed by QA, no impact | Neha Rao |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Added electronic logger guidance and deviation form annexure | Regulatory Compliance Update |