On 23 November, EMEA updated an interesting question-and-answer document.
It gives the answers to 4 questions dealing among others with PAT, Design Space
and process validation.
What is interesting about this document is that the EMEA argues in a
similar way as the FDA. The answers show that the EMEA generally shares
the ideas of FDA's Initiative "cGMP for the 21st Century". EMEA
supports, for example, the implementation of the PAT approach. However,
there is one crucial difference: The FDA sees more freedom in the process
changes on the part of the drug/API manufacturers if they have a
comprehensive and provable understanding of the manufacturing process. The
EMEA, on the other hand, considers the registration authorities to play
the more important part, since they have to approve of these changes. Yet,
both agencies are of the opinion that changes can be made without
variation application if they are carried out within a defined
"Design Space".
The updated version of the Q-and-A document shows that EMEA has
subscribed to FDA's view. In the 4th question, EMEA picks up the FDA's
interpretation of "continuous validation". According to this,
the 3 PQ validation batches are not necessary any more in case
detailed knowledge was generated within the framework of product
development.
If you want to read the Q-and-A document, please click here.
|
|
Especially on the topic of PAT in microbiological quality control, we
are organising the Masterclass Course:
PAT in Microbial QC
- Unit 1: Rapid Methods
- Unit 2: Identification Techniques
in Berlin, Germany, from 25-27 January 2006
|
