ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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GxP Regulation

Refers to the underlying international life science requirements such as those set forth in the US FD&C Act, US PHS Act, FDA regulations, EU Directives, Japanese MHLW regulations, or other applicable national legislation or regulations under which a company operates.

Publication Source: GAMP® Good Practice Guide: IT Infrastructure Control and Compliance

Publication Date: 2005

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