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 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.
TGA has published a media release stating that they have started to undertake "remote and/or hybrid GMP domestic inspections" in place of on-site inspections.
Due to the effects of the corona pandemic, the European Commission is extending the comment period for the revision of Annex 1 of the GMP Guide.
The topic data integrity raises a multitude of questions. Current questions are addressed in a loose sequence of News. Question 8: Must there be regulations for remote access by service providers to GxP-critical systems and what data integrity requirements must they contain?
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.
The European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the COVID-19 pandemic.
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.
Despite the MRA, FDA is still coming to the EU to inspect. Now a company from Bulgaria received a Warning Letter and was placed on Import Alert.