CMC Guidelines Updated
The updated guideline is structured in the CTD format applied to Module 3 section 3.2.P.3 Manufacture. The guideline was updated to provide clarification on the type and level of information that should be included in section 3.2.P.3 taking into consideration the ICH Q8 (R2) guidelines. The description of the manufacturing process should;- Include information on the critical steps
- Include information on the intermediates
- Demonstrate how pharmaceutical development, proposed control strategy and process validation are linked
- Consider the emergence of complex supply chains
- Consider issues with prolonged holding times
- Consider transportation conditions