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According to EU GMP Annex 1 (2022 revision), when performing Aseptic Process Simulation (media fills) for conventional aseptic filling, what is the maximum acceptable number of contaminated units when filling fewer than 5,000 units?

Knowledge QAEu Annex1hard
Question

According to EU GMP Annex 1 (2022 revision), when performing Aseptic Process Simulation (media fills) for conventional aseptic filling, what is the maximum acceptable number of contaminated units when filling fewer than 5,000 units?

Choices

  1. A. Zero contaminated units
  2. B. One contaminated unit with an investigation
  3. C. One contaminated unit should result in a failed media fill; however any contaminated unit requires investigation
  4. D. Up to 0.1% of total units filled

Cross-Model Comparison

No models have been evaluated on this test case yet.

Tags

media_fillsaseptic_process_simulationcontamination