Pharmaceutical Microbiological Contamination Testing Checklist
Microbiological testing is critical to pharmaceutical product safety, especially for sterile and parenteral products. This checklist reviews all elements of the pharmaceutical microbiology testing program per USP standards.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Monthly
- Estimated Time: 30-45 minutes
- Role: QA Manager / Microbiologist
- Total Items: 31
- Compliance: USP <71> Sterility Tests, USP <61> Microbiological Examination of Nonsterile Products - Microbial Enumeration Tests, USP <62> Microbiological Examination - Tests for Specified Microorganisms, USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments
Sterility Testing (USP <71>)
Review sterility testing program compliance.
- Sterility testing performed in Grade A/ISO 5 environment per USP <71>?
- Growth promotion test performed on each new lot of media?
- Membrane filtration method used where bacteriostasis/fungistasis validated?
- Positive and negative controls included with each sterility test run?
- 14-day incubation completed at required temperatures with documentation?
Bioburden Testing (USP <61>/<62>)
Review bioburden and specified microorganism testing.
- USP <61>/<62> methods validated with neutralization (bacteriostasis/fungistasis)?
- Alert and action limits established for bioburden with trending?
- Testing for specified/objectionable organisms per product requirements?
- Organism identification capability available for environmental isolates?
- Correct incubation media, temperatures, and times for organisms sought?
Endotoxin and Pyrogen Testing
Review endotoxin testing program.
- LAL test (gel clot, turbidimetric, or chromogenic) validated per USP <85>?
- Maximum Valid Dilution (MVD) and dilution series validated per product?
- Product interference (inhibition/enhancement) confirmed absent or corrected?
- Positive product control and negative controls included in each test?
- Control Standard Endotoxin (CSE) within expiration with current RSE comparison?
Pharmaceutical Water Microbiology
Review water system microbiological monitoring.
- Water system microbiological testing per validated sampling plan?
- Water system alert and action limits current and being followed?
- Water OOS/OOT results triggering investigation and corrective action?
- WFI endotoxin testing per USP frequency?
- Water microbiological trending reviewed monthly?
Environmental Monitoring Program
Review EM program effectiveness.
- EM sample collection per approved schedule with no missed points?
- All environmental monitoring isolates identified to species level?
- EM data trended by location, organism type, and classification level?
- All alert and action limit exceedances investigated and CAPA initiated?
- EM program reviewed annually and updated based on trend data?
Media and Culture Management
Verify media preparation and culture management.
- Growth promotion testing on all prepared or purchased media lots?
- Prepared media sterility tested before use?
- Reference culture strains from ATCC or DSMZ - documented passage history?
- Working cultures stored per requirements with passage limits documented?
- Microbiological waste disposed as biohazardous waste per regulations?
- Monthly microbiology program report prepared?
Related Pharmaceutical Life Sciences Checklists
- Pharmaceutical Water System Inspection Checklist
- Pharmaceutical QC Laboratory Inspection Checklist
- Pharmaceutical Water System Inspection Checklist
- Pharmaceutical Supplier Qualification Audit Checklist
- Pharmaceutical Cold Chain and Temperature-Sensitive Logistics Inspection Checklist
- Pharmaceutical Packaging Materials Audit and Inspection Checklist
- GxP Training Compliance and Competency Audit Checklist
Related Laboratory Checklists
- Pharmaceutical QC Laboratory Inspection Checklist - FREE Download
- Pharmaceutical Water System Inspection Checklist - FREE Download
Why Use This Pharmaceutical Microbiological Contamination Testing Checklist?
This pharmaceutical microbiological contamination testing checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / microbiologist professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: monthly.
Ensures compliance with USP <71> Sterility Tests, USP <61> Microbiological Examination of Nonsterile Products - Microbial Enumeration Tests, USP <62> Microbiological Examination - Tests for Specified Microorganisms, USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Microbiological Contamination Testing Checklist cover?
This checklist covers 31 inspection items across 6 sections: Sterility Testing (USP <71>), Bioburden Testing (USP <61>/<62>), Endotoxin and Pyrogen Testing, Pharmaceutical Water Microbiology, Environmental Monitoring Program, Media and Culture Management. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 30-45 minutes.
Who should use this Pharmaceutical Microbiological Contamination Testing Checklist?
This checklist is designed for QA Manager / Microbiologist professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.