At the end of February 2010, the European Medicines Agency (EMA) published a draft paper revising their process validation guidelines
Elements from the guidelines ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality Systems) are to flow in, particularly in the process areas of Analytical Technology (PAT), Quality by Design (QbD) and Real Time Release Testing (RTRT).
It is planned that the final document will be ready in the 4th quarter of 2011.
The concept paper on this guideline can be downloaded here
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