The US Food & Drug Administration (FDA) published a deviation report for Biological Products and HCT/P for Fiscal Year 2016, comparing the results with the two years before.
The European Directory for the Quality of Medicines and Healthcare Products (EDQM) published a guidance document on the handling and root-cause alanysis of Non-Conformity results in quality assements.
The European Medicines Agency, EMA, announced a new timeline in its press release dated 6 October 2017. According to this, the EU GCP Regulation will be applied mid-2019 at the earliest.
The Federal Assembly has revised Art. 64a of the Therapeutic Products Act which regulates cross-border inspections. Read more about the changes in the Swiss Therapeutic Products Act.
More and more frequently, FDA inspectors find fundamental GMP deficits at facilities producing finished medicinal products. The following analysis of recent warning letters shows that the final testing of pharmaceutical products for compliance with the specifications can not always be taken for granted.
Despite Brexit, the British "Medicines and Healthcare products Regulatory Agency" (MHRA) informs about new EU regulations for medical devices.
In a recent news you could read about a question-and-answer document from the EMA, describing certain issues concerning the handling of changes after approval ("variations"). This document has been updated again. The topic of changes to medical devices after the approval of "combination products" has now been added.
How are OOE and OOT results in the pharmaceutical industry to be recorded and assessed nowadays? To answer this question, the ECA Quality Control Working Group and representatives from authorities and industry compiled a guidance document about the handling of Out-of-Expectation (OOE) and Out-of-Trend (OOT) results. Find out more about the 70 page OOS/OOT guidance document.
Once again, the FDA has issued a Warning Letter to an Indian pharmaceutical manufacturer. Failure to fully investigate the scope and root causes of reported complaints and to take appropriate action regarding recalls of defective products were the main points of criticism. Find out more about the deficiencies in complaint and recall handling that resulted in a Warning Letter.