GMP NEWS 2020

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the first revision of the common document "Questions And Answers On Regulatory Expectations For Medicinal Products For Human Use During The Covid-19 Pandemic". The update includes a question on GDP certificates and wholesale authorisations.

In the middle of 2019, the WHO published the draft of the guideline entitled "Production of water for injection by means other than distillation" for the production of WFI by non-distillative methods. This finalised guideline has now been published as Annex 3 in the WHO Technical Report Series (TRS) 1025.

With its new Regulation 2020/561, the EU has postponed the beginning of application of the Medical Devices Regulation 2017/745 for one year to May 26, 2021. The Regulation will only be effective after this date. The European Association of Notified Bodies in the Medical Devices sector (Team NB) has now issued a statement on the new regulation.

An FDA draft guideline describes (non-binding) feedback after an FDA inspection of a Medical Device manufacturer. This guideline has now been finalized and was released in April 2020. What changes have been made?

The USP Cannabis Expert Panel has published an article on the quality requirements for medical cannabis in the Journal of Natural Products. The article describes the appropriate use of USP General Chapters related to chromatographic methods and controls for contaminants.

The modification and deletion of electronic data must be documented by an audit trail. A missing audit trail led to a Warning Letter to the Indian company Shriram Institute for Industrial Research.

The general Ph. Eur. monograph on Essential Oils has been published for comment in the recent issue of Pharmeuropa together with a proposed new Ph. Eur. chapter 5.30. Monographs on essential oils.

During the current Sars-CoV-2 outbreak, there are sometimes delivery problems with medicines, medical devices and protective equipment. Unfortunately, this also brings up many fraudsters, as a case revealed by Interpol shows.

A Warning Letter was inevitable when FDA inspectors found that even basic GMP requirements were not being met at a Chinese production site.