Analyst: Perform the sampling as per procedure and ensure sample integrity.

Warehouse Personnel: Assist in identification and retrieval of required units for sampling.

Quality Assurance: Verify sampling records and ensure samples are appropriately labeled and stored.

4. Accountability

The Head – Quality Control is accountable for ensuring proper and compliant sampling of gel products.

5. Procedure

5.1 Sampling Plan and Approval

1. Prepare a batch-specific sampling plan based on the packaging configuration (tubes, jars, sachets, etc.).
2. Sampling should be statistically representative (e.g., ANSI/ASQ Z1.4 or ISO 2859 standard).
3. QA must approve the sampling plan before execution.

5.2 Sample Withdrawal

1. QC analyst shall wear clean protective clothing and gloves before entering the storage area.
2. Locate the batch in the quarantine storage area using the batch transfer records and inventory log.
3. Randomly select units from different shipper boxes/pallets as per approved sampling plan.
4. Withdraw additional units as control samples, reserve samples, and for stability testing if applicable.

5.3 Labeling and Documentation

1. Each sampled unit must be labeled with:
   • Sample Type (QC/Control/Reserve)
   • Batch Number
   • Date of Sampling
   • Sampler’s Initials
2. Enter sample details in the Sampling Logbook (Annexure-1).
3. Update the Batch Sampling Record (Annexure-2) and affix it on the batch shipper or pallet.

5.4 Sample Storage and Transfer

1. Transport samples in clean, labeled containers or ziplock bags to the QC lab.
2. Store reserve and control samples in designated controlled storage areas.

5.5 Precautions

• Use sterile forceps or gloved hands for handling if the product is sensitive to microbial contamination.
• Avoid any damage or contamination to the packaging during withdrawal.
• Do not sample units with defective packaging or unclear labeling—report such issues to QA.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance

7. Documents

1. Sampling Logbook – Annexure-1
2. Batch Sampling Record – Annexure-2
3. Batch Manufacturing Record
4. Product Labeling SOP

8. References

• WHO TRS 986 – Annex 2: GMP Guidelines
• Schedule M – Quality Control Section
• FDA CFR 21 Part 211.110 – Sampling and Testing

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: Sampling Logbook

Date	Batch No.	Product Name	Sample Type	Sampler Name	Remarks

Annexure-2: Batch Sampling Record

Batch No.	Product Name	Date of Sampling	Units Sampled	QA Signature	Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
03/06/2022	1.0	Initial SOP release	New Documentation	QA Head
02/06/2025	2.0	Updated sampling procedures and annexure formats	Annual Review	QA Head