Procedure for Antimicrobial Effectiveness Testing
1) Purpose
The purpose of this SOP is to outline the procedure for evaluating the effectiveness of antimicrobial preservatives in pharmaceutical products to ensure microbial control and product safety.
2) Scope
This SOP applies to all pharmaceutical formulations containing antimicrobial preservatives that require antimicrobial effectiveness testing as part of quality control.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting antimicrobial effectiveness testing and ensuring compliance with this SOP.
Microbiology Laboratory: Responsible for performing microbial challenge tests and interpreting results.
4) Procedure
4.1 Sample Preparation:
4.1.1 Obtain representative samples of pharmaceutical products containing antimicrobial preservatives.
4.1.2 Follow aseptic techniques during sample collection and handling.
4.1.3 Ensure samples are properly labeled and stored according to specified conditions.
4.2 Inoculum Preparation:
4.2.1 Prepare microbial challenge organisms suitable for the product type and antimicrobial preservatives.
4.2.2 Confirm the purity and viability of microbial cultures before inoculation.
4.2.3 Adjust the microbial inoculum to achieve desired concentrations for challenge testing.
4.3 Antimicrobial Challenge Testing:
4.3.1 Inoculate test product samples with prepared microbial challenge organisms at specified concentrations.
4.3.2 Incubate inoculated samples under controlled conditions to promote microbial growth.
4.3.3 Retrieve samples at designated intervals and assess microbial viability or growth inhibition.
4.4 Viability Assessment:
4.4.1 Plate aliquots
4.4.2 Incubate plates under appropriate conditions to allow for microbial colony formation.
4.4.3 Count microbial colonies and calculate viable counts or inhibition zones as applicable.
4.5 Interpretation of Results:
4.5.1 Compare microbial counts or growth inhibition zones against acceptance criteria specified in pharmacopeial standards or internal specifications.
4.5.2 Determine the effectiveness of antimicrobial preservatives based on test results and validate compliance with regulatory requirements.
4.5.3 Document and report test findings, including any deviations or out-of-specification results.
4.6 Acceptance Criteria:
4.6.1 Pharmaceutical products are considered acceptable if they demonstrate effective inhibition or reduction of microbial challenge organisms.
4.6.2 Ensure all antimicrobial effectiveness testing adheres to validated procedures and method validation parameters.
4.7 Documentation:
4.7.1 Record all antimicrobial effectiveness testing procedures, results, and observations in the Antimicrobial Effectiveness Testing Report.
4.7.2 Maintain detailed records of sample details, microbial challenge preparations, incubation conditions, and test interpretations.
4.7.3 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Antimicrobial Effectiveness Testing Report
Microbial Challenge Preparation Records
Incubation Log Sheets
7) Reference, if any
USP General Chapter <51> – Antimicrobial Effectiveness Testing
Pharmacopeial standards for Antimicrobial Effectiveness Testing
8) SOP Version
Version 1.0
