finished product, or stability testing programs.

3. Responsibilities

• Microbiology Analyst: Conducts microbial tests according to validated procedures.
• QC Manager: Reviews data and ensures adherence to pharmacopeial requirements.
• QA Officer: Verifies documentation and reviews OOS or abnormal results.

4. Accountability

The Head of Quality Control is accountable for ensuring proper execution and documentation of microbial testing activities.

5. Procedure

5.1 Sample Collection

1. Collect representative samples in sterile containers under aseptic conditions.
2. Ensure that sample volume and container type meet testing requirements.
3. Record details in the Sample Receipt Log (Annexure-1).

5.2 Sterility Testing

1. Perform testing as per USP <71>, IP, or EP monograph.
2. Use membrane filtration method or direct inoculation depending on product characteristics.
3. Incubate media:
   • Fluid Thioglycollate Medium (FTM): 30–35°C
   • Soybean Casein Digest Medium (SCDM): 20–25°C
4. Monitor for microbial growth for 14 days and document observations.

5.3 Bioburden Testing

1. Determine microbial load prior to sterilization using:
   • Membrane filtration
   • Pour plate or spread plate method
2. Calculate CFU/mL and compare with predefined acceptance criteria.

5.4 Microbial Limits Testing (MLT)

1. Conduct MLT for non-sterile intermediates or stability samples.
2. Perform Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC), and tests for specified pathogens.

5.5 Result Interpretation and Documentation

1. Document results in the Microbial Testing Report (Annexure-2).
2. Compare observations against specifications as per pharmacopeia.
3. Report OOS/OOT results to QA and initiate investigation.

5.6 Handling of Positive Results

1. In case of microbial growth in sterility tests:
   • Perform identification of organism.
   • Initiate a deviation report and risk assessment.
2. Repeat testing only upon justified approval by QA.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• CFU: Colony Forming Units
• USP: United States Pharmacopeia
• MLT: Microbial Limit Testing

7. Documents

1. Sample Receipt Log – Annexure-1
2. Microbial Testing Report – Annexure-2
3. Sterility Test Observation Log – Annexure-3

8. References

• USP <71> Sterility Tests
• Ph. Eur. 2.6.1, 2.6.12, 2.6.13
• WHO TRS 961 Annex 6

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QC Microbiologist	QA Executive	Head QA
Department	Quality Control	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Sample Receipt Log

Date	Batch No.	Product Name	Test Type	Received By
15/06/2025	INJ-2025-001	Amikacin Injection	Sterility	Sunita Reddy

Annexure-2: Microbial Testing Report

Batch No.	Test Type	Result	Specification	Remarks
INJ-2025-001	Sterility	No growth	No growth for 14 days	Pass

Annexure-3: Sterility Test Observation Log

Date	Batch No.	Medium	Incubation Temp.	Result	Tested By
16/06/2025	INJ-2025-001	FTM	30–35°C	No growth	Rajesh Kumar
16/06/2025	INJ-2025-001	SCDM	20–25°C	No growth	Rajesh Kumar

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial version	New SOP	QA Head
18/06/2025	2.0	Added microbial limits section	Periodic Review	QA Head