Glossary
Sterility Test
A test that checks by the pharmacopoeial method whether viable microorganisms are detected in a sample.
Details
The sterility test is a detection test on a limited, destructively taken sample, so it cannot substitute for process design, validation, and contamination control. Inspections concentrate on method suitability, negative and positive controls, growth promotion, incubation conditions, the investigation of an initial positive, and the justification for any retest. Look together at the test raw data and growth promotion testing, organism identification, environmental and process data, and the investigation of positives and the basis for the batch disposition.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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You have not further evaluated, or provided data to demonstrate, your firm’s rapid sterility test method is suitable for its intended purpose.
FDA · FDA Warning Letter · 2024-05-14 -
Your firm used (b)(4) media lot (b)(4) to release sterility testing of Sodium Acetate Injection (in vials).
FDA · FDA Warning Letter · 2025-07-03 -
Your firm performed sterility testing for over (b)(4) lots of finished drug products purported as sterile but failed to effectively establish a system for monitoring environmental conditions to ensure ISO 5 air quality within the testing equipment and in adjacent areas.
FDA · FDA Warning Letter · 2022-08-30
