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LATEST NEWS
11
August
2022
GAMP®5, a Risk-Based Approach to Compliant GxP Computerized Systems Guidelines, is a globally accepted standard for the validation of computerised systems that has been recently revised. In the end of July 2002, a new 2nd edition has been published.
09
August
2022
European Commission published the Implementing Regulation (EU) 2022/1107 to establish common specifications for certain class D in vitro diagnostic medical devices (IVD’s) considered to be high-risk.
09
August
2022
U.S. Food and Drug Administration Agency (US FDA) is announcing the availability of a draft guidance for industry titled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.
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