kit: sampling rods, triers, thief samplers

Sample containers (clean, inert, airtight)

Sterile gloves, masks, PPE, and gowning items

Sampling labels and forms

Verify environmental conditions of the sampling area:

• Temperature and humidity should be within defined limits.
• Area should be clean and sanitized before each sampling session.

5.2 Review of Documents

1. Collect and verify the following prior to sampling:
   • Purchase Order (PO)
   • Certificate of Analysis (CoA)
   • Material Receiving Checklist
2. Ensure each container is labeled with a unique identification number and “UNDER TEST” label.

5.3 Sampling Procedure

1. Randomly select containers as per the sampling plan:
   • √n + 1 sampling plan for ≤100 containers
   • For critical materials, 100% sampling may be performed
2. Open containers aseptically and collect required quantity from:
   • Top, middle, and bottom layers (for powders and granules)
   • Center (for liquids using dip rod or pipette)
3. Transfer samples to clean containers and label with:
   • Material name
   • Batch number
   • Date of sampling
   • Sampler’s initials

5.4 Sample Types and Quantity

1. Collect the following sample types:
   • Analytical Sample
   • Retain Sample (as per regulatory requirement)
   • Microbiological Sample (if applicable)
2. Sample quantity depends on the testing protocol and nature of material:
   • Solvents: 500 mL to 1 L
   • Excipients: 250 g to 500 g
   • APIs: 100 g to 250 g

5.5 Post Sampling Activities

1. Seal the sampled containers with “Sampled” sticker and sign/date it.
2. Close and secure remaining containers with tamper-evident seals.
3. Complete the Raw Material Sampling Record (Annexure-1).
4. Deliver samples to QC with proper documentation and sample receipt log (Annexure-2).

5.6 Handling of Atypical Observations

1. Report observations like:
   • Discoloration
   • Foul odor
   • Container damage
2. Segregate suspected containers and inform QA for further investigation.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis
• PPE: Personal Protective Equipment

7. Documents

1. Raw Material Sampling Record (Annexure-1)
2. Sample Receipt Log (Annexure-2)
3. Environmental Monitoring Log (if applicable)

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• 21 CFR Part 211 – Current Good Manufacturing Practice
• WHO Technical Report Series 1010

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Raw Material Sampling Record

Material Name	Batch No.	Sampled From Containers	Sample Quantity	Date	Sampler
Citric Acid	CA/0425/003	5 of 20	250 g	12/04/2025	Sunita Reddy

Annexure-2: Sample Receipt Log

Sample ID	Material Name	Batch No.	Received By (QC)	Date	Remarks
QC-SMP-0425-013	Citric Acid	CA/0425/003	Rajeev Sharma	12/04/2025	Accepted

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial SOP Release	New SOP Creation	QA Head
12/04/2025	2.0	Updated sampling plan, annexures, and clarified responsibilities	Regulatory Alignment	QA Head