Ein GMP-Berater erkl?rt: The EU GMP Guide - Strongsuits and Pitfalls.

Introduction Proper: The EU GMP Guide - A Smart System - but a Text Prone to Misconceptions.

Applied with care and sience-based undestanding the EU GMP Guide is probably the most effective and also flexible product quality assurance standard out there. At the same time it is also susceptible to misunderstandings and misuse like no other GMP regulatory work I know - for a variety of reasons. The most common misconceptions I have encoutered in several years of GMP-related work - they range from simple misunderstandings of good documentation practices in small businesses with uncritical products, to extreme misinterpretations such as debating away entire media fill exercises.

The strengths this GMP Guide has - for example its degree of freedom to apply product and process subject matter expertise in hammering out the quality system and its degree of depth - those very same strengths force it in many places to be written in broad principles rather than in normative details.

Furthermore, what makes the EU GMP Guide quite tricky to read and to apply is not only that it is a consensus document rather than a clear cut lawful text, but also that many - and I mean really MANY are not aware any more of the context from which and into which the GMP Guide was given. The way the text is now has a history, a path it has come along until now, and this is part of the meaning and points to the way it must be read. The EU GMP Guide is well known for that fact that one cannot(!) simnply take it just literally and at face value. Admittingly the EU GMP Guide makers are trying quite hard to bend the Guide to international regulations and sometimes even claim that certain concepts were always intended for its current interpretation.

Where time alows it I will try and post a short series to cover the EU GMP Guide - at first Part I - chapter by chapter - and elaborate briefly on what its about and on some of the tricky points each chapter contains. So if this is of any interest for You - feel welcome to follow this. So if You are one for academics: consider this the introduction proper - although it is not an academic thesis as is obvious.