Responsibilities

• QC Analyst: Perform the sampling activity using validated tools and techniques as per the sampling plan.
• Warehouse Personnel: Present quarantined material in the correct sequence and assist during sampling.
• QA Officer: Review sampling records and ensure GMP and gowning practices are followed.

4. Accountability

The Head of Quality Control is accountable for ensuring proper implementation of sampling procedures and compliance with GMP requirements.

5. Procedure

5.1 Preparation for Sampling

1. Ensure sampling is performed in a dedicated, validated sampling booth with differential pressure and HEPA filtration.
2. Check environmental conditions and log temperature, humidity, and pressure differentials before starting.
3. Wear appropriate personal protective equipment (PPE) as per gowning SOP.
4. Verify cleanliness of sampling tools and containers; sterilize if required.

5.2 Sampling Plan and Strategy

1. Follow the sampling plan as per ICH Q7 or √n+1 approach:
   • √n+1, where n = total number of containers
   • Minimum of 10% of total containers must be sampled
2. Sample randomly from different positions – top, middle, bottom – using a thief sampler, scoop, or zone sampler.
3. Prepare both individual samples (if required) and a composite sample for routine analysis.
4. Use clean and inert sampling containers labeled with:
   • Material name
   • Batch number
   • Date of sampling
   • Sampled by (initials)

5.3 Sampling Procedure

1. Place containers on a designated platform and inspect physical condition before opening.
2. Use pre-sanitized tools and avoid contamination during sampling.
3. Open each selected container under LAF and take sample volume as specified in the material specification file.
4. Record the sample weight and seal containers properly after sampling.
5. Affix “Sampled” labels on all containers from which samples were drawn.

5.4 Sample Transfer and Documentation

1. Transfer samples to the QC lab with the “Sample Transfer Form” (Annexure-2).
2. Document all details in the “Raw Material Sampling Log” (Annexure-1), including number of containers sampled, tool used, sample quantity, and sampling personnel.
3. If a sample shows any unusual appearance or odor, notify QA and record it in the deviation register.

5.5 Cleaning and Closure

1. After sampling, clean the sampling booth and disinfect all used tools.
2. Update the cleaning log and leave the area ready for the next activity.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• LAF: Laminar Airflow
• PPE: Personal Protective Equipment

7. Documents

1. Raw Material Sampling Log (Annexure-1)
2. Sample Transfer Form (Annexure-2)
3. Sampling Plan Template (Annexure-3)

8. References

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• WHO TRS 986 Annex 2
• 21 CFR Part 211.84 – Testing and approval of components

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Rajesh Kumar	Sunita Reddy	Manoj Verma
Designation	QC Officer	QA Executive	QA Manager
Department	API Manufacturing	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Raw Material Sampling Log

Date	Material	Batch No.	No. of Containers	Qty Sampled	Sampled By
13/04/2025	Citric Acid	CA20250413	10	500g	Rajesh Kumar

Annexure-2: Sample Transfer Form

Date	Material	Batch No.	Transferred To	Transferred By
13/04/2025	Citric Acid	CA20250413	QC Laboratory	Sunita Reddy

Annexure-3: Sampling Plan Template

Total Containers	Sampling Plan Used	No. of Containers Sampled	Approach
10	√n+1	4	Random + Stratified

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2022	1.0	Initial Release	New SOP	QA Head
13/04/2025	2.0	Added Sample Plan and Transfer Protocol	Annual SOP Review	QA Head