GMP manuals - GMP publications
The Good Manufacturing Practices (GMP) are defined in a multitude of laws, guidelines and guidance documents.
In our series of GMP manuals and publications you will find compilations of the most important regulations, checklists and analyses on the GMP-compliant manufacture of medicinal products and active pharmaceutical ingredients.
GMP Regulations in Europe and Germany
In Europe, the EU GMP Guide (Part 1 and Part 2) and its annexes form the basis for the surveillance by the competent supervisory authority. In Germany, these GMP requirements are implemented in the ordinance for the manufacture of medicinal products and active pharmaceutical ingredients (AMWHV). The AMWHV is the corresponding implementing regulation for the German Drug Law (AMG) with regard to the GMP-compliant manufacture and quality assurance.
All three regulations - the EU GMP Guide, the AMWHV and the AMG - are available as practical GMP reference books.
GMP Regulations by the Food and Drug Administration (FDA) in the US
The American health authority FDA has laid down the GMP requirements in the Code of Federal Regulations (CFR). 21 CFR 210/211 formulates the GMP requirements on medicinal products. Moreover, the FDA has published the interpretation of the cGMP Guide in a large number of guidance documents. Here, the FDA Guidance "Sterile Drugs Produced by Aseptic Processing" holds an exceptional position, since in the field of sterile manufacture the requirements are especially strict. On our ordering page you can find the FDA cGMP Guide as well as the German translation of the FDA Aseptic Guides as practical GMP paperbacks.
ICH Q7 "GMP for Active Pharmaceutical Ingredients"
The GMP requirements on the manufacture of active pharmaceutical ingredients (APIs) are harmonised worldwide by the International Conference on Harmonisation (ICH). The ICH Q7 (formerly ICH Q7A) defines the requirements in the most important pharmaceutical markets: the USA, Europe, and Japan. The ICH Q7 Guide with APIC's "How to Do" Guide can also be ordered as paperback.
With the GMP checklists on the basis of the EU GMP Guide and with the cGMP Guides by FDA, you can check your site's current state against the GMP regulations within the framework of an audit/inspection.
To order the paperbacks and checklists, please use the
GMP Publications Site.