GMP stands for “Good Manufacturing Practice” or German “Gute Herstellpraxis”. Thus, GMP contains policies and regulations that always have to be observed, if organizations deal with the production and handling of products which may affect humans’ quality of life. Among them are medicinal products and food but also cosmetics. Since quality deviations can have immediate effects on the human health, quality assurance plays a central role especially in pharmaceutical production. Thus, organizations in this sector are obliged to introduce a GMP-compliant quality management system to guarantee the required product quality and to comply with legal requirements for the marketing of their system.
A GMP-compliant quality management consist of several elements such as the document management for specification documents to name but one. Requirements include that the specification documents such as work instructions, process instructions, form sheets etc. must be version-controlled and subject to a defined lifecycle. Moreover, these documents must have an audit trail in which all actions, especially changes, are to be logged. Without compliance to the GMP regulations, no organization gets the approval to produce pharmaceutical products.