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)?
FDA published the second revision of their Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs -Development, Analysis, and Presentation" to define the requirements on a overall microbiology development program for such products.
In the USA, combination products are regulated independantly. A draft document from the FDA entitled "Principles of Premarket Pathways for Combination Products" describes the ways in which marketing authorisations are granted in the USA and how the various Centers interact.
With the entry into force of the FDA Reauthorization Act (FDARA) in August 2017, sections on the inspection of medical device manufacturers in the USA and abroad also became effective. A draft document from the FDA on inspections of medical device manufacturers has been issued for some time now to further harmonize and interpret the changes.
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.
In October 2019, the FDA issued guidelines in a draft document regarding the use of a Type V Drug Master File (DMF). In this document, information can be made available to the CDER (if it is in charge of the (project) approval procedure) concerning the medical device proportion of a combination product.
Reaching step 5 of the harmonisation process, the European Medicines Agency (EMA) adopted the ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration.