GMP NEWS 2008

26.11.2008

FDA`s New Process Validation Guidance - A detailed analysis

The industry has been waiting for the American Food & Drug Administration (FDA) to publish its revision of the Process Validation Guideline. Now the Agency has made its current thinking regarding process validation public. A summary of the new draft can be found here.

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08.10.2008

FDA Changes CGMP Rules (21 CFR 210/211)

In early September, the American Food & Drug Administration (FDA) published changes to the CGMP rules in the Federal Register. Apart from the background and a summary, the document also includes comments on the Agency's original draft as well as its answers to them. Details can be found here.

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10.09.2008

FDA Submission Requirements on Parametric Release for End-Sterilised Products

For products terminally sterilised by means of moist heat processes, parametric release is available as an alternative to sterility testing. In a new draft, the FDA defines the requirements on parametric release within the framework of an application for a marketing authorisation. More can be read here.

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04.03.2008

10th APIC Conference on Active Pharmaceutical Ingredients

On 24 to 26 October 2007 APIC held its 10th European Conference on Active Pharmaceutical Ingredients. More than 200 participants from 25 countries met in Warsaw in order to discuss current and future regulatory requirements.

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