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.
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.
U.S. Food and Drug Administration Agency (US FDA) is announcing the availability of a draft guidance for industry titled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.
The European Medicines Agency (EMA) will be updating its Guideline on active substances to incorporate strategies for controlling and preventing nitrosamines in drug products and active pharmaceutical ingredients
Compressed gases are used in a lot of different steps during pharmaceutical manufacturing
The definition of whistleblowing as per the Collins English dictionary is the act of telling the authorities or the public that the organization you are working for is doing something immoral or illegal."
As part of US FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug applicants.
The U.S. Food & Drug Administration (FDA) posted an article on the ways the FDA is regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food, and cosmetics (Is it Really “FDA Approved”).
USP Headquarters recently published the intend to revise the Description and relative solubility of USP and NF Articles reference table.
Proposed changes of biocidal products should be classified in different categories
