People. Progressive. Principled

When is an IMP not an IMP? When it’s an AMP.

The definition of Investigational Medicinal Product (IMP) and the use of Auxiliary Medicinal Product (AMP) are the subject of a recent consultative document from the European Commission’s expert group on clinical trials for the implementation of regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. The consultative document was published on … Continued

Reflection on GMP/GDP Consultative Committee Minutes: 18th April 2016

The GMP/GDP consultative committee met recently on the 18 April 2016 at the MHRA offices in Buckingham Palace Road, London. The attending bodies consisted of quality associations, Industry associations and professional organisations. Among the many interesting topics discussed were the topical subjects of data integrity and harmonisation.

GXP data integrity culture and unity

If you turn to that font of all known knowledge, the internet and search the term “data integrity” you will find a common definition of “maintaining and assuring the accuracy and consistency of data over its entire life-cycle”. All in all this is not a bad definition.