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eQMS para Ciências da Vida 20 itens

Media Fill / Aseptic Process Simulation (APS) Checklist

Este checklist está em inglês.

Verifies that an aseptic process simulation is designed, executed, and evaluated to demonstrate the capability of the aseptic process. Use to plan and assess media fill runs.

EU GMP Annex 1FDA Aseptic Processing Guidance 2004PDA TR22

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Design and Protocol

  • Is the media fill designed to simulate the routine aseptic process including duration and line speed? *
  • Does the protocol define the number of units to be filled to represent the process? *
  • Is a growth-promotion-capable microbiological medium (or suitable placebo) selected and justified? *
  • Record the target number of filled units for the run.

Worst-Case Conditions and Interventions

  • Are inherent and corrective interventions included to represent worst-case aseptic activity? *
  • Are the maximum number of personnel and shift/campaign durations simulated? *
  • Are interventions documented contemporaneously during the fill? *
  • Are container/closure and line configurations representative of production? *

Incubation and Environmental Monitoring

  • Are filled units incubated at the defined temperatures and durations? *
  • Is a growth promotion test performed on the media used? *
  • Is environmental and personnel monitoring performed during the media fill? *
  • Are all integral units accounted for and reconciled? *

Acceptance Criteria and Results

  • Is the run evaluated against the target of zero contaminated units for typical batch sizes? *
  • Record the number of contaminated (positive) units observed.
  • Are all reject/discarded units reconciled and their exclusion justified? *
  • Is the run read by a qualified microbiologist and documented? *

Investigation and Requalification

  • Is any positive unit investigated for root cause including organism identification? *
  • Is the impact on released product and line status assessed for a failed media fill? *
  • Is periodic requalification (typically semi-annual per line/operator) scheduled? *
  • Quality unit approval of the media fill result. *

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