Standard Operating Procedure for Microbial Limits Testing for Gels

1) Purpose

The purpose of this SOP is to establish procedures for conducting microbial limits testing on gels to ensure compliance with microbiological safety standards.

2) Scope

This SOP applies to the Quality Control (QC) department responsible for performing microbial limits testing on gels manufactured at the pharmaceutical manufacturing facility.

3) Responsibilities

Quality Control (QC): Perform microbial limits testing according to defined procedures and standards.
Quality Assurance (QA): Oversee the implementation of microbial limits testing procedures and ensure compliance with SOPs and regulatory guidelines.
Microbiology Laboratory: Provide expertise and support for microbial testing methodologies.

4) Procedure

4.1 Sample Collection and Preparation
4.1.1 Collect representative samples from finished gel batches with documented batch/lot numbers and production records.
4.1.2 Prepare samples aseptically to avoid contamination during testing.

4.2 Microbial Limits Testing
4.2.1 Perform tests for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) using suitable agar media and incubation conditions.
4.2.2 Follow pharmacopoeial methods or company-specific validated methods for microbial testing.

4.3 Method Validation
4.3.1 Validate microbial testing methods to ensure accuracy, precision, and sensitivity.
4.3.2 Document validation protocols and results for each method used.

4.4 Interpretation of Results
4.4.1 Evaluate test results against pharmacopoeial limits or company specifications.
4.4.2 Record and document microbial counts for each tested sample.

4.5 Compliance Assessment
4.5.1 Compare microbial test results with acceptance criteria and specifications.
4.5.2 Document compliance or non-compliance with microbial limits.

4.6 Reporting and Documentation
4.6.1 Prepare detailed test reports documenting test results, compliance status, and any deviations.
4.6.2 Maintain accurate records of all microbial limits testing activities, including protocols, data sheets, and reports.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
TAMC: Total Aerobic Microbial Count
TYMC: Total Yeast and Mold Count

6) Documents, if any

– Microbial Limits Testing Protocols and Procedures
– Test Reports and Data Sheets
– Method Validation Reports

7) Reference, if any

– Pharmacopoeial monographs (e.g., USP, Ph. Eur.) on microbial limits testing requirements
– Company-specific microbiological testing standards and guidelines

8) SOP Version

Version 1.0