Procedure for Microbial Limits Testing in Non-Sterile Products
1) Purpose
The purpose of this SOP is to outline the procedure for conducting microbial limits testing on non-sterile pharmaceutical products to ensure compliance with microbiological quality standards.
2) Scope
This SOP applies to all non-sterile pharmaceutical products manufactured within the facility that require microbial limits testing as part of quality control.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting microbial limits testing and ensuring compliance with this SOP.
Microbiology Laboratory: Responsible for performing microbial enumeration and identification tests.
4) Procedure
4.1 Sample Preparation:
4.1.1 Obtain representative samples of non-sterile products from different batches.
4.1.2 Follow aseptic techniques during sample collection and handling.
4.1.3 Prepare sample dilutions as necessary to achieve viable microbial counts.
4.2 Incubation and Enumeration:
4.2.1 Inoculate appropriate culture media with sample dilutions according to specified incubation conditions.
4.2.2 Incubate plates or other culture vessels under controlled temperature and humidity for a predetermined period.
4.2.3 Count microbial colonies on culture plates using suitable enumeration techniques (e.g., colony counting, membrane filtration).
4.3 Identification (if applicable):
4.3.1 Perform microbial identification tests for isolates exceeding specified limits or as per product specifications.
4.3.2 Use biochemical tests, molecular techniques, or other validated methods for microbial identification.
4.3.3 Record and report microbial identification results accurately.
4.4 Data Analysis:
4.4.1 Calculate microbial counts per unit volume or weight of the non-sterile product.
4.4.2 Compare microbial counts against acceptance criteria specified in pharmacopeial standards or internal specifications.
4.4.3 Document test results, including any deviations or out-of-specification findings.
4.5 Acceptance Criteria:
4.5.1 Non-sterile products are considered acceptable if microbial counts are within specified limits.
4.5.2 Ensure all microbial limits testing adheres to validated procedures and method validation parameters.
4.6 Documentation:
4.6.1 Record all microbial limits testing procedures, results, and observations in the Microbial Limits Testing Report.
4.6.2 Maintain detailed records of sample details, testing conditions, media preparation, and incubation parameters.
4.6.3 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Microbial Limits Testing Report
Sampling Plan Document
Culture Media Preparation Records
7) Reference, if any
USP General Chapter <61> – Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests
Pharmacopeial standards for Microbial Limits Testing in Non-Sterile Products
8) SOP Version
Version 1.0