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eQMS para ciencias de la vida 15 elementos

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

Esta lista de verificación está en inglés.

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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