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.
U.S. Food and Drug Administration Agency (US FDA) is announcing the availability of a draft guidance for industry titled Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.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
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”).
The current Q3D(R2) Guideline reached Step 4 on 26th of April 2022, and included a correction of PDE’s for gold, silver and nickel, Gold and Silver monographs and an addition of limits for elemental impurities by the cutaneous and transcutaneous route.
Commission Regulation (EU) 2022/63 of 14 January 2022 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the food additive titanium dioxide (the Regulation) entered into force following its publication in the Official Journal of the European Union on 18th January 2022.
US Food and Drug Administration Agency (US FDA) has announced the availability of a proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs).
Transition period for the use of the In Vitro Diagnostic Regulation 2017/746 (IVDR) came to an end, hence as of 26th of May its provisions are mandatory to be followed by all in vitro diagnostic medical device sector.
Parallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing authorisation holder.
The purpose of this consultation is to collect relevant information from stakeholders to help the GMP/GDP Inspectors Working Group to finalise this Question and Answers guidance on remote batch certification / confirmation by the QP on a routine basis.
European Commission (EC) is reporting progress in implementing strategic approach to pharmaceuticals in the environment. This approach involves all phases of lifecycle of pharmaceuticals, from development, manufacture, use and disposal.
A regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123).
Medical device manufacturers should
be aware of obligations laid down in
Article 15 of the MDR where there is
requirement for person responsible
for regulatory compliance (PRRC)
which also checks conf…