GMP = Good Manufacturing Practice

The term GMP has been used for around 45 years and stands for Good Manufacturing Practice. Translated, this means "good manufacturing practice" or better "recognized rules of good manufacturing practice". GMP is a comprehensive quality assurance system that must be followed when manufacturing certain products in order to maximize consumer protection. Originally, GMP rules were initially created for pharmaceuticals, since - in the case of inferior quality - these products pose the greatest risks to humans or animals. GMP rules have gradually been transferred to more and more industrial and manufacturing sectors, ultimately to all those areas where the products are used on humans or animals.

Unfortunately, there is not a specific GMP set of rules, rather there are various specifications. Which of these requirements should be applied concretely, which of them are binding and which present the state of science and technology depends on various factors. A first important aspect is the question of which products are manufactured, for example pharmaceuticals, active ingredients, foods, cosmetics or animal feed. Another important aspect: Where are the products manufactured or sold - in the US, Europe or Asia? If this is done exclusively in Europe, only the European requirements apply. However, if the products are imported to the US, the US regulations must be adhered to. In addition, it does matter how products are made, for example chemically or biologically, sterile or non-sterile, or how products are administered to humans or animals, such as orally, parenterally or topically. Regardless of the aforementioned factors and industry-independent, GMP rules always follow the same three core objectives:

  • Avoiding any kind of contamination,
  • Consistent, reproducible product quality as well
  • Traceability.
  • Regardless of which requirements are placed in detail on the products or their production, these can be traced back to one of these three core goals time and again.

FDA = US Food and Drug Administration

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.