3.2.S.2.6 - Manufacturing Process Development

For new chemical entities, a description and discussion regarding significant changes made to the manufacturing process or manufacturing site of the API should be provided, including:

  1. Non-clinical batches;
  2. Clinical batches;
  3. Scale-up batches;;
  4. Pilot batches; and
  5. Commercial scale batches, if available.
  • For APIs not classified as new chemical entities, the DIFA holder may include data from the manufacturing process development to support the control strategy.

For APIs developed by quality by design, the studies that support the design space should be provided.

  • For APIs developed by quality by design, the DIFA holder should comply with ICH Q8(R2) (Pharmaceutical Development), Q9 (Quality Risk Management) e Q10 (Pharmaceutical Quality System).