Elixir Department: SOP for Sampling of Final Product for QC – V 2.0

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Elixir Department: SOP for Sampling of Final Product for QC – V 2.0

Standard Operating Procedure for Sampling of Final Product for Quality Control Testing

Department Elixir Department
SOP No. SOP/ELX/211/2025
Supersedes SOP/ELX/211/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the standard procedure for sampling of final elixir product for quality control (QC) testing prior to batch release. This ensures representative, contamination-free sampling and compliance with regulatory and internal requirements.

2. Scope

This SOP applies to the sampling of finished elixir formulations from the final bulk container or filling tank prior to packing, performed by authorized personnel from Quality Control and Quality Assurance.

3. Responsibilities

  • QC Analyst:
    • Collect final samples as per sampling plan and test requirements.
    • Label, transport, and document samples appropriately.
  • Production Supervisor:
    • Ensure the product is ready for sampling and provide access to tank or containers.
  • QA Officer:
    • Verify that the sample collected is representative and procedure is followed.
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4. Accountability

The QC Head is accountable for correct and timely sampling. The QA Head is responsible for verifying compliance and authorizing sample testing and batch

review.

5. Procedure

5.1 Pre-Sampling Checks

  1. Ensure final blending, volume adjustment, and in-process checks are completed.
  2. Obtain line clearance from QA before sampling.
  3. Ensure the sampling area is clean, sanitized, and labeled appropriately.

5.2 Sampling Equipment and Containers

  1. Use clean and dry stainless steel or glass sampling apparatus.
  2. Use sterile and chemically inert sample containers (amber glass or HDPE bottles with screw caps).
  3. Label sample containers prior to use with:
    • Product Name
    • Batch Number
    • Date and Time of Sampling
    • Sampler Name
    • Test Purpose (e.g., Assay, Microbial, Stability)

5.3 Sampling Process

  1. Collect sample from the top, middle, and bottom layers using a zone sampler or through outlet valve depending on container design.
  2. Mix samples from different zones thoroughly to form a composite sample.
  3. Collect minimum quantity as per QC requirement:
    • Assay & Related Substances: 100 mL
    • Microbial Testing: 50 mL (sterile container)
    • pH, Viscosity, Other Routine Tests: 100 mL
    • Stability Sample (if applicable): 250 mL
  4. Do not allow sampling to interrupt batch integrity or introduce contamination.
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5.4 Post Sampling Activities

  1. Seal all containers securely and immediately.
  2. Transport samples to the QC lab in a clean secondary container.
  3. Record details in the Final Product Sampling Logbook (Annexure-1).
  4. Attach the sampling data sheet to the Batch Manufacturing Record (BMR).

5.5 Re-sampling Procedure

  1. If re-sampling is required due to breakage, spillage, or OOS investigation:
    • Obtain approval from QA.
    • Use a fresh sampling set and containers.
    • Label as “Re-sample – Investigation” and cross-reference original sample.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • QC: Quality Control
  • BMR: Batch Manufacturing Record
  • OOS: Out of Specification
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7. Documents

  1. Final Product Sampling Logbook (Annexure-1)
  2. Sampling Data Sheet
  3. Batch Manufacturing Record (BMR)

8. References

  • WHO TRS 1019 – Annex 3: GMP for Pharmaceutical Products
  • 21 CFR Part 211.160 – Sampling and Testing of Final Product
  • ICH Q6A – Specifications: Test Procedures and Acceptance Criteria

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Final Product Sampling Logbook

Date Batch No. Sampling Point Sample Type Quantity Sampled By QA Verified
11/04/2025 ELX-0425-029 Final Tank Outlet Composite Sample 250 mL Rajesh Kumar Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New SOP QA Head
11/04/2025 2.0 Updated sampling zones and re-sampling protocol Process Improvement QA Head
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