Standard Operating Procedure for Microbial Limits Testing for Creams
1) Purpose
The purpose of this SOP is to define procedures for conducting microbial limits testing on creams. This ensures that creams meet specified microbial quality standards and are safe for distribution and use.
2) Scope
This SOP applies to the Quality Control Department and personnel responsible for conducting microbial limits testing of creams. It covers testing methods, acceptance criteria, documentation, and reporting requirements.
3) Responsibilities
The Quality Control Manager is responsible for overseeing microbial limits testing activities. The Quality Control Team and Testing Technicians are responsible for executing and ensuring compliance with this SOP.
4) Procedure
4.1 Sampling
4.1.1 Select representative samples of creams from the batch for testing.
4.1.2 Ensure samples are taken aseptically and in accordance with sampling plans.
4.1.3 Label each sample with batch information and identification numbers.
4.2 Preparation of Test Samples
4.2.1 Prepare cream samples according to specified dilution or extraction methods suitable for microbial testing.
4.2.2 Ensure samples are handled under aseptic conditions to avoid contamination.
4.3 Testing Method
4.3.1 Perform microbial limits testing using validated methods such as membrane filtration or plate count methods.
4.3.2 Follow compendial or company-specific procedures for microbial testing.
4.4 Incubation
4.4.1 Incubate test samples under appropriate conditions and temperatures required for
4.4.2 Monitor samples periodically during incubation for microbial growth and contamination.
4.5 Enumeration and Calculation
4.5.1 Count microbial colonies on plates or membranes following incubation.
4.5.2 Calculate microbial counts per gram or per milliliter of cream sample.
4.6 Acceptance Criteria
4.6.1 Establish acceptance criteria for microbial limits based on regulatory requirements, pharmacopeial standards, and product specifications.
4.6.2 Compare test results against acceptance criteria to determine pass or fail status for each sample.
4.7 Documentation and Reporting
4.7.1 Document all microbial limits testing activities, including sample preparation, testing methods, procedures, results, and observations.
4.7.2 Prepare microbial limits testing reports summarizing test conditions, results, conclusions, and recommendations.
4.7.3 Obtain approval from Quality Control Management for microbial limits testing reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
USP: United States Pharmacopeia
6) Documents, if any
Microbial Limits Testing Protocols
Microbial Limits Testing Reports
Non-Conforming Material Reports
7) Reference, if any
USP : General chapters related to microbial limits testing of pharmaceutical products
Company-specific microbiological testing procedures
8) SOP Version
Version 1.0