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According to ICH Q7, at what point in the manufacturing process should GMP be applied to the production of an API?

Knowledge QAIch Q7easy
Question

According to ICH Q7, at what point in the manufacturing process should GMP be applied to the production of an API?

Choices

  1. A. GMP applies only to the final isolation and purification steps
  2. B. GMP applies from the step where the API starting material is introduced into the process
  3. C. GMP applies from the synthesis of the first intermediate
  4. D. GMP only applies during packaging and labelling

Cross-Model Comparison

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Tags

starting_materialsgmp_application_point