What is GMP?

GMP (Good Manufacturing Practice) is the part of quality assurance that ensures consistent quality standards in the production and testing of medicinal products or active ingredients (APIs).

Human health is the primary concern. In everyday life, patients must feel they can rely on the high quality of a medicinal product, as they cannot check this themselves. The quality of a medicinal product is determined above all by the following factors:

  • Identity (are the specified ingredients contained?)
  • Content (are the ingredients present in the specified quantity?)
  • Purity (is the medicine free of ingredients that do not belong in it?)

The quality, efficacy and safety of a medicinal product must be ensured. These must be proven to the competent authority, which grants approval for the drug, because: without marketing authorisation, a medicinal product may not be marketed to patients. How can these requirements be met? And: how can consistent quality be ensured if it is not possible to individually test each tablet that is pressed? This is the purpose of good manufacturing practice. The principles of good manufacturing practice apply to almost all areas of a company, from research and development to production, quality control, storage and distribution. Anyone who manufactures, tests, stores or markets medicinal products or APIs on a commercial basis must therefore implement a series of defined requirements. The basic principle is that companies must manufacture medicines in such a way that they are suitable for their intended use.

Where does GMP come from?

The basis for GMP requirements is the cGMP (Current Good Manufacturing Practice) Guide, which the U.S. Food & Drug Administration (FDA) published in the Federal Register in 1978. With this, the authority had created the world's first legally anchored GMP regulations. These made it possible for the manufacturing processes of pharmaceutical companies to be monitored by a regulatory authority.

However, the topic also gained importance internationally.

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