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

1. Ensure purified bulk has passed all in-process checks (e.g., pH, bioburden, conductivity).
2. Transfer bulk in pre-cleaned and validated stainless steel or single-use containers as per batch record.
3. Seal containers with tamper-evident ties and label as per Section 5.2.

5.2 Labeling of Bulk Containers

1. Apply GMP-compliant label with following details:
   • Product name
   • Batch number
   • Quantity/volume
   • Storage temperature range
   • Status: Quarantine / Released
   • Date and time of storage
2. Labels must be water-resistant, legible, and affixed securely.

5.3 Storage Conditions

1. Store bulk in designated refrigerated chamber at 2–8°C or per product-specific conditions.
2. Place on validated stainless steel racks or pallet systems avoiding direct contact with walls or floor.
3. Environmental conditions must be monitored with calibrated sensors and auto-alarms.
4. Log temperature every 30 minutes using electronic data logger (Annexure-1).

5.4 Quarantine and Hold Duration

1. Place bulk under “QUARANTINE” status until QA batch release is completed.
2. Do not use for filling or formulation until QA provides written release.
3. If storage exceeds hold-time limit defined in the stability protocol, raise a deviation.

5.5 Transfer to Fill-Finish or Formulation

1. Release transfer initiated only upon QA clearance.
2. Transfer must follow cold-chain handling SOP (refer SOP/BS/192/2025).
3. Document transfer time, personnel, and destination (Annexure-2).

5.6 Deviation Management

1. Any deviation in storage conditions, labeling error, or temperature excursion must be recorded and investigated.
2. 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

1. Bulk Storage Temperature Log – Annexure-1
2. Bulk Transfer Record – Annexure-2
3. 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