after isolation.

3. Responsibilities

• Production Chemist: Ensure availability of clean, suitable sampling tools and containers.
• QC Analyst: Provide guidance on sample quantity and labeling requirements.
• QA Officer: Review sampling records and ensure compliance with sampling plan.

4. Accountability

The Production Head is accountable for ensuring samples are collected safely and in a representative manner. The QA Head is responsible for overall procedural compliance.

5. Procedure

5.1 Preparation for Sampling

1. Verify sampling requirement from the BMR or sampling plan.
2. Use tools such as:
   • PTFE or SS spatulas
   • Viscous material samplers (rod samplers or syringes with wide bore)
   • Pre-labeled HDPE or glass containers with wide mouths
3. Wear appropriate PPE: gloves, goggles, apron.
4. Ensure tools and containers are dry, clean, and inert to the material sampled.

5.2 Sampling Method

1. Stir the material if possible to obtain a uniform consistency before sampling.
2. Collect sample from at least three locations if material volume permits:
   • Top
   • Middle
   • Bottom
3. If the material is in a drum or wide vessel, insert rod sampler or scoop diagonally to capture layered sample.
4. For very sticky substances, lubricate sampler with small quantity of the same material to ease collection.
5. Transfer sample into labeled container using a spatula or low-friction scraper.
6. Seal the container immediately to avoid material sticking to lid threads.

5.3 Sample Labeling

1. Use IPC Sample Label (Annexure-1) indicating:
   • Sample Code
   • Batch Number
   • Date & Time of Sampling
   • Stage
   • Sampler Name
2. Attach label securely. Do not apply directly to wet or sticky surfaces.

5.4 Cleaning of Equipment

1. Clean sampling tools immediately using suitable solvent (e.g., IPA) or warm water if water-soluble.
2. Dry and inspect for residual material before next use.

5.5 Documentation

1. Record sampling in the IPC Sampling Logbook (Annexure-2) including:
   • Date and Time
   • Material Name and Batch No.
   • Quantity Sampled
   • Tool Used
   • Remarks
2. QC shall acknowledge receipt of sample and initiate testing within defined timeframe.

6. Abbreviations

• SOP: Standard Operating Procedure
• IPC: In-Process Control
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. IPC Sample Label (Annexure-1)
2. IPC Sampling Logbook (Annexure-2)

8. References

• ICH Q7 – GMP for APIs
• 21 CFR Part 211 – US FDA GMP
• WHO TRS 986 – GMP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: IPC Sample Label

Sample Code
Batch No.
Material
Date & Time
Stage
Sampler Name

Annexure-2: IPC Sampling Logbook

Date	Batch No.	Material	Sample Qty	Tool Used	Sampler	Remarks
13/04/2025	API-20250413	Sticky Intermediate A	20 g	SS Rod Sampler	Ravi Kumar	Uniform Sample

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	GMP Compliance	QA Head
13/04/2025	2.0	Added multi-point sampling method and improved cleaning instruction	Audit Update	QA Head