Officer: Responsible for coordinating and facilitating sampling activity.

QC Analyst: Responsible for collecting, labeling, and documenting samples as per sampling plan.

QA Executive: Oversight to ensure sampling activities comply with cGMP and documentation requirements.

4. Accountability

The Head of Quality Control is accountable for ensuring compliance with the sampling procedure.

5. Procedure

5.1 Types of Samples

1. Raw Material Samples: Collected before manufacturing starts, based on predefined sampling plan.
2. In-Process Samples: Collected at defined stages to monitor consistency, pH, viscosity, and homogeneity.
3. Semi-Finished Product Samples: Taken before filling to confirm compliance with bulk specifications.

5.2 Sampling Points and Frequency

• Sampling shall be performed at:
  • After initial gel base preparation
  • Post API addition
  • Post homogenization
  • Before bulk transfer for filling
• Sampling frequency must follow batch manufacturing record (BMR) and product-specific SOPs.

5.3 Sampling Tools and Containers

• Use clean and sterile sampling spatulas or pipettes.
• Sampling containers must be:
  • Amber or white high-density polyethylene jars
  • Sterilized and appropriately labeled

5.4 Sample Collection

1. Ensure proper gowning before entering the sampling area.
2. Label each sampling container with:
   • Product name
   • Batch number
   • Date and time of sampling
   • Sample type and point
3. Collect the required volume (usually 10–50g for gels) using sanitized equipment.
4. Seal and transfer the samples to the QC lab immediately.

5.5 Documentation

• Record sampling details in the Sample Collection Logbook (Annexure-1).
• QC to maintain sample receipt records and initiate testing as per internal timelines.

5.6 Precautions

• Avoid contamination by using gloves and sterile sampling equipment.
• Do not reuse containers or tools without proper cleaning and sterilization.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record

7. Documents

1. Sample Collection Logbook – Annexure-1
2. Sample Label Template – Annexure-2

8. References

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• WHO Technical Report Series No. 986, Annex 2 – GMP for Pharmaceuticals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Sample Collection Logbook Format

Date	Batch No.	Sample Type	Sampling Point	Container No.	Collected By	Remarks

Annexure-2: Sample Label Template

Sample Type:
Batch Number:
Product Name:
Sampling Point:
Date:
Time:
Collected By:

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
30/05/2022	1.0	Initial issue	New SOP release	QA Head
02/06/2025	2.0	Added Annexures and detailed sampling plan	GMP Compliance Update	QA Head