Good Manufacturing Practice is the term used to refer to various national and international guidelines that apply to all pharmaceutical manufacturers, along with laws and regulations drawn up to ensure quality assurance of pharmaceutical manufacturing and packaging processes.
The methods used by an individual company to implement these rules must be fully documented in a comprehensive quality management system. Quality assurance relates to the following areas: staff, operating premises and facilities, documentation, manufacturing and testing. Other areas affected are labelling, storage and transport, hygiene standards and self-inspection of the system in order to achieve constant improvement of quality management. Compliance with these guidelines as well as legally binding certification is verified by the competent supervisory authority, the regional council.

The Food and Drug Administration is responsible for monitoring food standards and registration of pharmaceutical products in the United States. Its task is to protect public health in the USA. The quality standards relating to the production of pharmaceuticals which are set by the FDA are similar to those set by GMP certification.

The FDA monitors compliance with requirements relating to production and operating premises on the legal basis of the Code of Federal Regulation (CFR), which is a highly detailed and strict set of regulations. The FDA monitors pharmaceutical companies in Germany that import pharmaceutical products into the USA. This cannot be done without passing inspection.