Control strategy ICHQ11- Post-approval CMC changes across the product lifecycle ICHQ12

To achieve consistent product quality, having a control strategy in place is non-negotiable.
Along the process development of the product:

  • How to establish the quality target product profile with related critical quality attributes?
  • How to identify the critical process parameters and quality attributes?
  • How to maintain the process under control?

Afterwards when the product is approved and, on the market :

  • How to deal with the implementation of post-approval CMC changes across the product lifecycle?

Here are the topics that will be discussed at the next A3P Switzerland forum to be held on May 10 in Lausanne.

10 May 2022
2:40 pm

Link to the conference