microbial testing and recording results.

QA Officer: To verify, audit and ensure testing procedures are compliant with regulatory standards.

QC Head: Final reviewer and approver of the microbial testing reports.

4. Accountability

The Head – Quality Control shall be accountable for the implementation and compliance of this SOP.

5. Procedure

5.1 Sample Collection

1. Collect samples aseptically from finished gel batches as per sampling SOP.
2. Label samples properly with batch number, product name, date, and initials.

5.2 Preparation of Media

1. Prepare required media such as Soybean Casein Digest Agar (SCDA), MacConkey Agar, and Sabouraud Dextrose Agar (SDA) as per USP/BP guidelines.
2. Sterilize media using autoclave at 121°C for 15 minutes.

5.3 Test Procedure

• Total Aerobic Microbial Count (TAMC):
  1. Perform serial dilution of gel sample in sterile saline or peptone water.
  2. Inoculate plates with specified dilution, incubate at 30–35°C for 3–5 days.
  3. Count colonies and express results in CFU/g.
• Total Yeast and Mold Count (TYMC):
  1. Use SDA for inoculation and incubate at 20–25°C for 5–7 days.
  2. Count and report colonies.
• Specified Pathogens (e.g., E. coli, S. aureus, P. aeruginosa):
  1. Follow pharmacopeial methods for enrichment and identification.
  2. Use selective media and confirm with biochemical tests.

5.4 Acceptance Criteria

Acceptable microbial limits shall be as per the latest pharmacopeial monograph or product specification document.

5.5 Documentation

1. Record all test details in the Microbial Testing Logbook.
2. Attach raw data, photographs (if required), and chromatograms with test reports.
3. Submit for QA verification and release decision.

5.6 Handling Out-of-Specification Results

1. Inform QA and initiate investigation per OOS SOP.
2. Retest if necessary under controlled conditions.

6. Abbreviations

• CFU: Colony Forming Units
• TAMC: Total Aerobic Microbial Count
• TYMC: Total Yeast and Mold Count
• SCDA: Soybean Casein Digest Agar
• SDA: Sabouraud Dextrose Agar

7. Documents

1. Microbial Testing Logbook – Annexure-1
2. Test Report Format – Annexure-2
3. Media Preparation and Sterility Record – Annexure-3

8. References

• USP <61>, <62> – Microbial Limits Tests
• BP – Microbiological Examination of Non-sterile Products
• Internal Quality Manual

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: Microbial Testing Logbook Format

Date	Sample Name	Batch No.	TAMC (CFU/g)	TYMC (CFU/g)	Pathogens	Analyst	Remarks

Annexure-2: Microbial Test Report Format

Parameter	Specification	Result	Conclusion
TAMC	<100 CFU/g
TYMC	<10 CFU/g
E. coli	Absent
S. aureus	Absent
P. aeruginosa	Absent

Annexure-3: Media Preparation and Sterility Record

Date	Media Name	Lot No.	Sterilization Details	Sterility Check Passed	Prepared By	Checked By

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/06/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Format updated and references revised	Compliance Update	QA Head