One of the most important and useful documents issued by the European association of API manufacturers is the so-called "How to do" Document. This paper interprets the ICH Q7 Guide’s GMP requirements manufacturers of active ingredients have to fulfil.
It was not the authors’ intention to create a manual for accomplishing a 100% GMP compliance. Much rather it intends to support API producing sites with a guide comprising practical examples and recommendations for solving problems for which the ICH Q7 Guide does not provide concrete answers. This intention also shows in the "How to do" Document’s title – contrary to the "What to do" character of ICH Q7. This is also the reason why it has become a valued counsel in the API industry since it was first issued. Version 6, which will be published soon, considers current developments and stands out again due to the practical approach and its actuality.
The following changes are exemplary: In addition to others, chapter 2 provides recommendations for a GMP compliant Change Control und the control respectively monitoring of the quality management system (e.g. through key data).
Chapter 3 specifies the requirements for trainings of staff in sensitive areas (e.g. aseptic production) and also provides tips for implementing them. The authors explicitly mention that the "How to do" Document is a "living" paper. This is also supported by the fact that the last revision was issued only 8 months ago.
Note: The new "How to do" Document will be introduced at the13th European Conference on Active Pharmaceutical Ingredients in Barcelona, Spain, from 27-20 October. Every delegate will receive a brochure with the side by side comparison of the ICH Q7 Guide and the "How to do" Document free of charge.
Dr. Gerhard Becker
On behalf of the European Compliance Academy (ECA)