On 20 February, the European Commission published the long-awaited revision of Annex 1 Sterile Manufacturing of the EU GMP Guideline. The document is now entering a timely limited commentary phase.
The Finnish Medicines Agency (Fimea) recently stated that Cannabidiol (CBD) is controlled as a medicine in Finland.
Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections, as a recent FDA Warning Letter shows.
The nickel plating of surfaces is a good and high-quality method to protect components or surfaces from corrosion. At the same time, the question is repeatedly asked whether components treated in this way may be used in the GMP area. Read more here.
We regularly analyse the deficiencies identified in FDA Warning Letters relating to medical products. The title for the analysis of the last fiscal year 2018 was: "Medical Device Warning Letters - Fiscal Year 2018 - CAPA no longer in 1st Place". Now, what is the situation for Fiscal Year 2019 (1 October 2018 - 30 September 2019)?
The introduction of alternative methods as, e.g., the Monocyte Activation Test, is a challenge for many laboratories.
The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.
A document on the topic of comparability in the context of Changes and Variations at ATMP, published in December by the EMA, respectively the CAT, completes the series of guidelines and assistance around ATMP.
The European Commission (EC) published an updated Version 2.3 of the Questions & Answers relating to the Clinical Trials Regulation.
The FDA published a new guideline on Adaptive Design Clinical Trials for Drugs and Biologics.