New EMEA Document Questions the 3 Validation Batches for the First Time

GMP News No. 653

GMP News
20 December 2005
 

New EMEA Document Questions the 
3 Validation Batches for the First Time

 
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

 
Compiled by:
Oliver Schmidt
on behalf of ECA
 

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