Procedure for Conducting On-the-Spot Microbial Testing
| Department | Quality Control (QC)/Microbiology |
|---|---|
| SOP No. | SOP/Ointment/079 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define a standardized method for conducting on-the-spot microbial testing in ointment manufacturing. This procedure ensures that the product remains free from microbial contamination at critical control points.
2. Scope
This SOP applies to Quality Control (QC) and Microbiology personnel responsible for performing on-the-spot microbial tests on raw materials, in-process samples, and finished ointments.
3. Responsibilities
- Microbiologist: Conducts microbial testing and records results.
- QC Analyst: Collects samples and ensures proper handling.
- Production Supervisor: Ensures adherence to microbial control measures.
- Quality Assurance (QA) Personnel: Reviews and approves microbial test reports.
4. Accountability
The QC and QA Managers are accountable for ensuring that microbial testing is performed accurately and documented as per GMP and regulatory guidelines.
5. Procedure
5.1 Equipment and Materials
- Sterile sampling swabs
- Agar plates (TSA, SDA, MacConkey)
- Petri dishes
- Incubator (30-35°C)
- Sterile forceps and gloves
- Laminar airflow hood
- Microbial testing logbook
5.2 Sampling for Microbial Testing
5.2.1 Raw Material Sampling
- Collect raw material samples using sterile containers.
- Test for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC).
5.2.2 In-Process Sampling
- Take samples at key process stages (e.g., mixing, filling).
- Use
swab sampling on equipment and work surfaces.
5.2.3 Finished Product Sampling
- Randomly select filled containers for microbial testing.
- Test for the presence of specific pathogens (Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa).
5.3 Microbial Testing Procedure
5.3.1 Total Aerobic Microbial Count (TAMC)
- Plate the sample on TSA (Tryptic Soy Agar).
- Incubate at 30-35°C for 48 hours.
- Count and record colony-forming units (CFU).
5.3.2 Total Yeast and Mold Count (TYMC)
- Plate the sample on SDA (Sabouraud Dextrose Agar).
- Incubate at 20-25°C for 5-7 days.
- Record fungal growth.
5.3.3 Pathogen Testing
- Use selective media for specific pathogens.
- Incubate at appropriate temperatures.
- Confirm results using biochemical tests.
5.4 Acceptance Criteria
- TAMC: Not more than 100 CFU/g.
- TYMC: Not more than 10 CFU/g.
- Pathogens: Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa must be absent.
5.5 Documentation
- Record all microbial test results in the Microbial Testing Log.
- Ensure that any deviations are documented and corrective actions taken.
- QA personnel must review and approve test results before batch release.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- TAMC – Total Aerobic Microbial Count
- TYMC – Total Yeast and Mold Count
7. Documents
- Microbial Testing Log (Annexure-1)
- Microbial Test Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- USP <1111> – Microbiological Examination of Nonsterile Products
- 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: Microbial Testing Log
| Date | Batch Number | Sample ID | TAMC (CFU/g) | TYMC (CFU/g) | Pathogens Detected | Result | Verified By |
|---|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | SMP-001 | 85 | 5 | None | Pass | QA Officer |
| 01/02/2025 | OINT-102 | SMP-002 | 92 | 8 | None | Pass | QA Officer |
Annexure-2: Microbial Test Report
| Date | Batch Number | Test Type | Acceptance Criteria | Result | Final Status | Approved By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | TAMC | ≤ 100 CFU/g | 85 CFU/g | Approved | QA Head |
| 01/02/2025 | OINT-102 | TYMC | ≤ 10 CFU/g | 8 CFU/g | Approved | QA Head |