Gmp Certification Service

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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).

This is a short excerpt from the eLearning course on GMP basics

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 product free of ingredients that do not belong in it?)

The EU Guidelines to Good Manufacturing Practice require that “The holder of a Marketing Authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation, as appropriate  and do not place patients at risk due to inadequate safety, quality of efficacy.”
This must be proven to the competent authority, which grants approval for the medicinal product, because: without marketing authorisation, a medicinal product may not be marketed to patients. How can these requirements therefore 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.

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: In Germany, for example, the German Medicines Act (AMG) was published in 1978 as a direct result of the thalidomide scandal. However, it did not yet contain any specific GMP requirements. It was not until 1985 that the “Pharma-Betriebsverordnung” was published. For the first time, this contained concrete GMP specifications for Germany, which formed the basis for GMP monitoring through inspections by the responsible authorities. It took another four years before the EC GMP Guidelines, which are binding for Europe, finally appeared in 1989. According to the German AMWHV §2, the guideline is now called the EU GMP Guideline and has been legally valid in Germany since 2005, which means that compliance with its specifications must be documented.

What are GMP rules?GMP rules are the requirements for quality assurance of the manufacturing processes and environment formulated by the European Commission in the principles and guidelines of Good Manufacturing Practice (GMP) for medicinal products for human use and active pharmaceutical ingredients. The EU GMP Guide describes how these rules are to be interpreted in Part I for medicinal products and in Part II for active substances, as well as in various annexes for specific product groups.