New suggestions by the USP on chapter <659> have been published in the Pharmacopeial Forum (PF) 44 (4). It addresses plastic packaging as well as the regulations and requirements for child-resistant packaging. Read more about chapter <659> - Packaging and Storage Requirements in this article.
After five years and thorough revision, the FDA Guidance "Bioanalytical Method Validation" has been finalised. Read here what requirements the FDA lays down for a completely validated bioanalytical procedure.
ICH Q12, currently in draft form for public consultation, provides an opportunity to save time and money associated with regulatory submissions. Read more about "new" lifecycle tools and enablers for global post-approval change management provided in the proposed guideline on "Life Cycle Management".
Published in its 21st edition by now, the GMP Matrix has been a recognised standard for GMP auditors or QA units since 2005, and not only in multinational companies. The Matrix juxtaposes the US cGMP requirements as per CFR 210/211 with the EU GMP Guidelines. What has changed in recent years in particular?
Quite a few supervising authorities in the health care sector come for GMP inspections also to foreign countries. Read what the Brazilian ANVISA and the Mexican COFEPRIS will expect.
The FDA published two new draft guidelines on Risk Evaluation and Mitigation Strategy (REMS) for sponsors of clinical trials. Read more about the draft documents on developing a shared system REMS, and waivers associated with the single, shared system REMS requirement.
The US Food and Drug Administration (FDA) recently issued two warning letters to a contract manufacturers based in Australia and a Korea-based drugmaker.
The EDQM has announced the suppression of the Highly Purified Water (HPW) Monograph (1927) in 2019. This was justified with the revision of the European Pharmacopoeia which now allows non-distillation methods for the production of water for injection (WFI). As a consequence, the monograph became redundant.
EU inspectorates already accept inspections of the FDA at US sites. But there will still be auditors coming from the EU to the US.
The EMA has announced a new timeline for the application of the Clinical Trials Regulation due to EMA`s move to Amsterdam because of the Brexit.