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.