SOP Guide for Pharma

Elixir Department: SOP for Sampling for Microbial Analysis – V 2.0

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Elixir Department: SOP for Sampling for Microbial Analysis – V 2.0

Standard Operating Procedure for Sampling for Microbial Analysis in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/064/2025
Supersedes SOP/ELX/064/2022
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 a standard procedure for sampling elixir formulations for microbial analysis during manufacturing, ensuring the microbial quality of the batch is within specified limits.

2. Scope

This SOP applies to in-process and finished product sampling for microbial analysis of all elixir formulations manufactured in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Collect samples aseptically using sterile sampling tools.
    • Ensure timely transfer to the microbiology lab.
  • QA Officer:
    • Monitor the sampling process and ensure proper documentation.
  • Microbiologist:
    • Perform microbial limit testing and report results to QA.

4. Accountability

The Quality Assurance Manager is accountable for ensuring that microbial sampling and testing are conducted as per cGMP and pharmacopoeial standards.

See also  Elixir Department: SOP for Use of Barcode Systems During Dispensing - V 2.0

5. Procedure

5.1 Sampling Time Points

  1. After final mixing and before filtration or filling.
  2. From the bulk storage tank (if applicable).
  3. Post-filtration (for finished product
testing, as per validation protocol).

5.2 Sampling Method

  1. Use sterile stainless steel or single-use sterile plastic containers.
  2. Wear complete sterile PPE before entering the sampling area.
  3. Open the tank sampling valve or manhole using sterile gloves and collect the sample aseptically.
  4. Label the container with:
    • Product name
    • Batch number
    • Date & time
    • Sampling point
    • Collected by

5.3 Sample Quantity

  1. Collect a minimum of 50 mL or as specified in the sampling plan.
  2. In case of duplicate testing or retention, collect additional quantity accordingly.

5.4 Transportation and Submission

  1. Place the labeled container in a secondary sterile container with a lid.
  2. Transport to microbiology laboratory within 1 hour of sampling.
  3. Submit the sample along with the Microbial Sample Submission Form (Annexure-1).

5.5 Testing and Results

  1. The microbiology department shall test the sample as per pharmacopoeial limits (e.g., USP/NF, IP).
  2. Typical tests include:
    • Total aerobic microbial count (TAMC)
    • Total yeast and mold count (TYMC)
    • Specified pathogens (e.g., E. coli, Salmonella, Pseudomonas aeruginosa)
  3. Test results shall be reported in the Microbial Test Report (Annexure-2).

5.6 Documentation

  1. Record sampling details in the Microbial Sampling Log (Annexure-3).
  2. Attach the approved microbial test report to the batch record.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • TAMC: Total Aerobic Microbial Count
  • TYMC: Total Yeast and Mold Count

7. Documents

  1. Microbial Sample Submission Form (Annexure-1)
  2. Microbial Test Report (Annexure-2)
  3. Microbial Sampling Log (Annexure-3)

8. References

  • USP <61> and <62> – Microbiological Examination of Non-Sterile Products
  • WHO GMP Guidelines for Liquid Dosage Forms

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Microbial Sample Submission Form

Date Batch No. Product Name Sampling Point Collected By Time
11/04/2025 ELX-1010 Paracetamol Elixir Post Mixing Rajesh Kumar 10:30 AM

Annexure-2: Microbial Test Report

Parameter Specification Result Status
TAMC Not more than 100 CFU/mL 30 CFU/mL Pass
TYMC Not more than 10 CFU/mL 2 CFU/mL Pass
E. coli Absent in 1 mL Absent Pass

Annexure-3: Microbial Sampling Log

Date Batch No. Sample Point Collected By Verified By
11/04/2025 ELX-1010 Post Mixing Rajesh Kumar Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP QA Head
11/04/2025 2.0 Included Multiple Sampling Points and Submission Form Regulatory Alignment QA Head
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