the Batch Manufacturing Record (BMR).

Production Supervisor: Verify sample labeling, integrity, and timely delivery to QA/QC.

QA Officer: Review sampling procedure and verify sample traceability during audits.

QC Analyst: Receive and test in-process samples and report deviations, if any.

4. Accountability

The Production Head is accountable for correct execution of sampling. QA Head is responsible for ensuring compliance and adequacy of sampling practices.

5. Procedure

5.1 Sampling Plan and Tools

1. Refer to the Master Batch Record (MBR) or Control Strategy for the stage-wise sampling points and quantity.
2. Use pre-cleaned stainless steel sampling scoops, thieves, syringes, or spatulas depending on material state (solid/liquid).
3. Use sterile or clean containers and label them before initiating sampling.

5.2 Personal Preparation

1. Wear appropriate PPE including gloves, mask, hairnet, and antistatic gown.
2. Disinfect hands and sampling tools before use.
3. Verify environmental conditions (e.g., area cleanliness, temperature/humidity) are within acceptable limits.

5.3 Sampling Technique

1. Open the vessel/container under LAF or in a controlled environment as per product requirement.
2. Withdraw the sample from designated locations (e.g., top, middle, bottom, or composite zones) to ensure representativeness.
3. Avoid contaminating the sample or container during transfer.
4. Immediately close the vessel/container after sampling and wipe external surface if any spillage occurred.
5. Transfer the sample to the designated container, close with secure lid, and apply label.

5.4 Sample Labeling

1. Ensure the following information is printed or written on the label:
   • Product Name
   • Batch Number
   • Stage of Sampling (e.g., Post-Drying, Pre-Milling)
   • Sample Type: In-Process
   • Sampled By (Name & Signature)
   • Sampling Date & Time

5.5 Sample Submission and Documentation

1. Submit the sample to the QC lab immediately upon collection.
2. Enter details in the “In-Process Sampling Logbook” (Annexure-1).
3. Attach the sample slip and BMR reference with the submitted sample.
4. QC shall acknowledge sample receipt and log it in the laboratory register.

5.6 Special Considerations

1. If material is hazardous, cytotoxic, or potent:
   • Follow containment procedures using isolators or dedicated enclosures.
   • Use closed loop sampling devices, if applicable.
   • Ensure sample containers are double-bagged before dispatch.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record
• PPE: Personal Protective Equipment

7. Documents

1. In-Process Sampling Logbook (Annexure-1)
2. Batch Manufacturing Record
3. Sample Submission Slip

8. References

• ICH Q8 – Pharmaceutical Development
• 21 CFR Part 211 – US FDA GMP Regulations
• WHO Technical Report Series 986 – GMP for APIs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: In-Process Sampling Logbook

Date	Batch No.	Sampling Stage	Sampled By	Time	Submitted To QC	Remarks
13/04/2025	API-20250413	Post-Drying		10:15	Yes	Sample sent for LOD

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New Sampling Process	QA Head
13/04/2025	2.0	Included special handling for potent materials	Regulatory Requirement	QA Head