Life-Sciences eQMS 15 items
Sterility and Bioburden Testing Checklist (USP <71> / <61>)
Ensures sterility testing and microbial enumeration (bioburden) are validated and performed under conditions that prevent false results and support release of sterile and non-sterile products. Use to audit the QC microbiology program.
USP <71>USP <61>USP <62>21 CFR 211.167
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Method Suitability and Validation
- Has method suitability (bacteriostasis/fungistasis) been established for each product prior to routine sterility testing? *
- Is membrane filtration used in preference to direct inoculation where the product permits?
- Have the specified challenge organisms recovered within the validation acceptance criteria? *
- Is growth promotion of each media lot confirmed before use? *
Sterility Test Execution
- Is sterility testing performed under ISO 5 (Grade A) conditions with appropriate environmental monitoring? *
- Is the sample quantity and number of units tested compliant with the batch-size table? *
- Are negative controls incubated alongside test articles for the full incubation period? *
- Is the incubation period at least 14 days at the specified temperatures? *
Bioburden Enumeration
- Is the microbial enumeration method suitability (recovery) validated for each product? *
- Are Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) determined? *
- Are specified/objectionable organism tests performed where required by the monograph? *
- Record the bioburden alert and action limits for the product or intermediate.
Invalidation and Disposition
- Are sterility test failures investigated per a defined procedure before any invalidation? *
- Is a test invalidated only with documented evidence of an assignable laboratory cause? *
- Is quality unit approval required to release sterile product based on passing sterility results? *
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