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Life-Sciences-eQMS 15 Punkte

Sterility and Bioburden Testing Checklist (USP <71> / <61>)

Diese Checkliste ist auf Englisch.

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? *

Vollständige Checkliste Sterility and Bioburden Testing Checklist (USP <71> / <61>) herunterladen

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