The manufacturing and pharmaceuticals are regulated in Germany in the Medicines Act (AMG).
At the end of August 2005, the 14th Amendment to the AMG came into force, which produced some interesting innovations, in particular for biological products and active ingredients. The further implementation of the AMG can be found in the legally binding Drug and Active Ingredient Production Ordinance (AMWHV), which has been in force since 6 September 2006 and replaces the previous Operating Regulation for Pharmaceutical Entrepreneurs (PharmBetrV). At European level, Directive 91/356 / EEC derives the so-called EC GMP Guide, the EU's GMP Foundations. Additional guidelines in the form of annexes to the EU GMP Guide regulate various detailed topics. In Europe, the current EU Directive 2004/27 / EC, which is about creating a Community codex for manufacturers of medicinal products for human use, is of key importance. Moving outside the economic area of the EU, regulates an intergovernmental agreement of the former EFTA countries, the PIC / S (Pharmaceutical Inspection Convention Scheme), the issue of GMP. The PIC / S GMP Guide is, with few exceptions, identical to its European counterpart. The FDA, the US Food and Drug Administration, has been and still is the pioneer in most GMP pharmaceutical product regulations.
In the US, the Food Drug and Cosmetic Act is the legal basis. The GMP rules for pharmaceutical products are listed in the Code of Federal Regulations 21 CFR Part 210/211. In addition, the FDA publishes more extensive interpretations in the GMP environment, usually either as an industry guidance (Guidance for Industry) or as a guidebook for the inspectors (Guide to Inspection). The FDA is exemplary in communication. For example, there are plenty of other highly interesting and helpful pieces of information on the FDA's websites, such as warning letters, manuals, and presentations by FDA inspectors. Worldwide guidelines on GMP are made by the World Health Organization (WHO). The basic rules can be found in the so-called "Technical Report Series". The International Conference on Harmonization (ICH) seeks to harmonize GMP rules for the ICH's US, Japan and Europe. In the area of pharmaceutical active ingredients, this has already been largely achieved with the ICH Q7.