European Pharmaceutical Industry presents its Expectations to the EU Note for Guidance on Process Validation

Last year, the European Medicines Agency (EMA) announced in a "Concept Paper" that they would revise their Note for Guidance on Process Validation from 2001 and focus on the product lifecycle.

The European Compliance Academy together with Concept Heidelberg conducted a survey in September 2011 to find out what the European pharma industry thinks about this approach. In total 509 professionals from industry and authorities provided their input to the survey. It is the most comprehensive survey ever performed on this topic.

In the following, you will find excerpts from the results. The complete evaluation has been published in the latest issue of the GMP Journal1 and has been mailed to the EU Commission and the EMA.

The current version of the Process Validation Guidance is mainly based on the 3 batch model. For the revision, the EMA had announced that they would implement modern aspects and concentrate more on a scientific approach and process understanding. Almost 87% of the respondents think that it would be necessary to modify the current validation requirements. A clear "No" was expressed by approximately 6%.

Although the majority is for a change of the approach of the current guidance, only half of the respondents (54.2%) think that the necessity has to do with the data quantity provdided by the 3 batch validation. For them, the data generated are not sufficient to show the process'/product's validity. However, a little more than a quarter of those questioned consider the data quantity to be enough to confirm validity. Noticeable is the group of undecided respondents (20% "not clear").

Asked for their estimation of the new FDA Guidance for Process Validation as a basis for a modern approach, almost 57% believe that the Guidance of the US authority would provide a good foundation. Little 3.4% thinks that the FDA Guidance would rather not be a good basis. Almost 40% of those answering have not decided yet. Only a few from the sceptics' group specified their opinion: "No clear / Too broad expectations" probably summarizes the single comments the best. Only two participants mentioned "growing expenses" as main reasons for their criticism.

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

1 The GMP Journal (english version) is published 2 times a year. This service is free service for ECA Members

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