In November 2008 the FDA published a draft to revise their old Guideline on Process Validation from 1987. The ECA analysed this draft (see GMP News from 26 November 2008) in details and evaluated a detailed survey about the content of this draft (see GMP News from 11 March 2009). The result of this survey was also sent to the FDA as a comment.
Now, on 25 January 2011 the FDA puplished the final version. What are the differences to the draft?
In summary, it is conspicuous that there are no big changes in the final version compared to the draft from November 2008. However, already slight differences could influence current industry practices. Nevertheless, there are some remarkable changes:
For detailed information please see the final guidance. A comprehensive analysis of the final guidance will be published on this webpage next week
At ECA´s 4th biannnual GMP Conference there will be as session which will highlight FDA´s new Process Validation Guidance but also the movement regarding Validation in Europe. Please see the conference website for more information.
The New FDA/EU Approach to Process Validation, 3-4 May 201, Vienna, Austria
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
PS: In the members area you find a comparision between the draft and the final guidance.