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.