GMP NEWS 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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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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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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