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

1. Confirm sampling schedule in the approved Batch Manufacturing Record (BMR).
2. Sanitize gloves, sampling port, and containers with 70% IPA before sampling.
3. Verify ID and calibration status of pH probe, DO probe, and temperature sensors.

5.2 Sampling Execution

1. Wear appropriate PPE and enter the classified area according to gowning procedures.
2. Label sterile sample containers with:
   • Batch number
   • Date and time of sampling
   • Sample type and volume
   • Operator initials
3. Use aseptic sampling valve or septum to collect:
   • 10–50 mL depending on test
   • Avoid drawing air into the line
4. Immediately cap and store samples at 2–8°C in designated transfer box.

5.3 Sample Transport and Handover

1. Transfer samples to the QC sample drop-off refrigerator by 06:30 hrs.
2. Fill Annexure-2: Night Sampling Transfer Log and obtain security sign-off.

5.4 Documentation and Traceability

1. Log all sampling activities in Annexure-1: Night Sampling Log Sheet.
2. Note any delays, abnormalities, or sample rejections and escalate to QA if required.

5.5 Deviation Handling

1. 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

1. Night Sampling Log Sheet – Annexure-1
2. 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