Under ICH Q7, what is the requirement for process validation of API manufacturing processes?

Choices

1. A. Process validation is only required for sterile APIs
2. B. Process validation should provide documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an API meeting specifications
3. C. Three consecutive validation batches are always mandatory regardless of the process type
4. D. Process validation may be replaced entirely by in-process testing