GMP NEWS 2020

Supplier Qualification and the respective contracts in outsourcing activities are always hot topics in inspections, as a recent FDA Warning Letter shows.

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)?

With their new questions and answers paper, the FDA wants to provide further information on the implementation of pathogen reduction techniques for blood establishments.

The application of the Medical Devices Regulation (2017/745, MDR) as of 26 May 2020 is approaching. Find out more about the MDR environment.

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 ICH E9(R1) Addendum to defining the appropriate Estimand for a Clinical Trial / Sensitivity Analyses reached Step 4 of the ICH Process.

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.

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.