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Under the revised EU GMP Annex 1, what is the recommended maximum time limit for holding filtered bulk solution before filling in an aseptic process, unless otherwise justified?

Knowledge QAEu Annex1medium
Question

Under the revised EU GMP Annex 1, what is the recommended maximum time limit for holding filtered bulk solution before filling in an aseptic process, unless otherwise justified?

Choices

  1. A. No specific time limit is mentioned
  2. B. The holding time should be minimised and a time limit established during process validation
  3. C. 48 hours at controlled room temperature
  4. D. 24 hours under refrigerated conditions only

Cross-Model Comparison

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Tags

aseptic_processingholding_timeprocess_validation