Standard Operating Procedure for Sampling During Night Shifts in Biosimilar Upstream Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/110/2025 |
| Supersedes | SOP/BS/110/2022 |
| 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 aseptic, accurate, and timely sampling during night shifts from upstream bioreactor systems in biosimilar manufacturing, ensuring sample integrity and traceability.
2. Scope
This SOP applies to all biosimilar upstream processing units where samples are collected between 18:00 and 06:00 hours from bioreactors, seed flasks, or media tanks for in-process testing.
3. Responsibilities
- Night Shift Operator: Perform aseptic sampling, labeling, and documentation.
- Night Shift Supervisor: Review sampling logs and approve any deviations.
- QC: Receive and analyze samples upon arrival, report any anomalies.
4. Accountability
The Production Manager is accountable for ensuring that night shift sampling complies with cGMP, data integrity, and in-process control requirements.
5. Procedure
5.1 Preparation Before Sampling
- Confirm sampling schedule in the approved Batch Manufacturing Record (BMR).
- Sanitize gloves, sampling port, and containers with 70% IPA before sampling.
- Verify ID and calibration status of pH probe, DO probe, and temperature sensors.
5.2 Sampling Execution
- Wear appropriate PPE and enter the classified area according to gowning procedures.
- Label sterile sample containers with:
- Batch number
- Date and time of sampling
- Sample type and volume
- Operator initials
- Use aseptic sampling valve or septum to collect:
- 10–50 mL depending on test
- Avoid drawing air into the line
- Immediately cap and store samples at 2–8°C in designated transfer box.
5.3 Sample Transport and Handover
- Transfer samples to the QC sample drop-off refrigerator by 06:30 hrs.
- Fill Annexure-2: Night Sampling Transfer Log and obtain security sign-off.
5.4 Documentation and Traceability
- Log all sampling activities in Annexure-1: Night Sampling Log Sheet.
- Note any delays, abnormalities, or sample rejections and escalate to QA if required.
5.5 Deviation Handling
- If sampling time deviates by more than ±30 minutes from scheduled time, raise a deviation record as per deviation SOP.
6. Abbreviations
- BMR: Batch Manufacturing Record
- QC: Quality Control
- PPE: Personal Protective Equipment
- IPA: Isopropyl Alcohol
7. Documents
- Night Sampling Log Sheet – Annexure-1
- Night Sampling Transfer Log – Annexure-2
8. References
- EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
- ICH Q9 – Quality Risk Management
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Night Sampling Log Sheet
| Date | Time | Sample Type | Volume | Bioreactor ID | Initials | Remarks |
|---|---|---|---|---|---|---|
| 04/05/2025 | 03:00 | In-process | 20 mL | BR-12 | Sunita Reddy | NA |
Annexure-2: Night Sampling Transfer Log
| Date | Time | No. of Samples | Delivered By | Received By (Security) | Remarks |
|---|---|---|---|---|---|
| 04/05/2025 | 06:20 | 3 | Ajay Verma | Security-02 | QC Notified |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Added sample transport log and deviation handling clause | Audit recommendation |