What does the FDA actually mean by CGMP?

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7/8 May 2024

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In the EU, but also in almost all PIC/S countries and at the WHO, Good Manufacturing Practice is referred to as GMP. The US Food and Drug Administration (FDA), however, refers to it as CGMP (formerly also cGMP). But what exactly is behind this? The FDA published a paper entitled "Facts About the Current Good Manufacturing Practices (CGMPs)" on this some time ago.

CGMP refers to FDA regulations on current Good Manufacturing Practice. According to the FDA, the CGMP requirements have been designed so flexibly that each manufacturer can decide for himself how best to implement them. Accordingly, the "C" in CGMP stands for "current", which means that companies must use technologies and systems that are up-to-date to comply with the regulations. Systems and equipment that were "top-of-the-line" 10 or 20 years ago to prevent contamination, mix-ups and errors may be inadequate by today's standards.

The FDA publishes regulations and guidance documents in the Federal Register. The FDA's website also contains links to CGMP regulations, guidance documents and various resources to help drug companies comply with the regulations.

The FDA emphasises that CGMP describes minimum requirements. Modern, comprehensive quality systems and risk management concepts can also go beyond these requirements.