In 2011, FDA revised their process validation guidelines to transform validation into a lifecycle process as apposed to an activity. This approach is consistent with EU GMP Annex 15. It is therefore desirable to use a similar model for analytical procedures. Please read more here

Because cleaning and control are critical in the manufacture of (bio) pharmaceuticals and medical devices, a formal microbiological risk analysis (MRA) should provide scientific justification for why and how often a particular disinfectant was used and for how often and in which change further (sporicidal) agents may have been used. The second part of this article discusses the lifecycle approach for confirming the disinfectant rotation programme. Please read more here

Is the US FDA really much stricter, as you can frequently hear? To be able to answer this question, one has to take a look at the differences to the European GMP requirements - and the similarities. Because, after all, any company doing business with its products in the US market will need to be aware of the specifics. Please read more here

The Mutual Recognition Agreement (MRA) - the Agreement on the Mutual Recognition of GMP Inspections of manufacturers of medicinal products for human use - between the EU and the US FDA has been applying since 1 November 2017. The purpose of this agreement is to increase the authorities' efficiency and thus to re-allocate resources for inspections in higher-risk countries. Please read more here