GMP NEWS 2016

On May 18, 2016, the US Food and Drug Administration (FDA) released a new policy document on applying ICH Q8, Q9, and Q10 principles to chemistry, manufacturing, and controls review. Read more on how agency staff in the Office of Pharmaceutical Quality (OPQ) should apply the recommendations in the ICH Q8, Q9 and Q 10 guidelines to CMC reviews.

Some time ago three Non-Compliance Reports have been published in quick succession in the EudraGMDP database. Those reports deal with inspections performed at pharmaceutical APIs production sites located in India. Read more about the fundamental violations of the requirements for GMP-compliant API manufacturing in those facilities.

Quality Metrics are a hotly-debated topic. At the end of July 2015, the U.S. FDA released a Draft Guide entitled "Request for Quality Metrics - Guidance for Industry". On the occasion of a keynote presentation at the Pharma Congress 2016, Dr Andreas König - Senior Vice President at Aenova - talked about the practical implementation and the challenges. Read more about Aenova's case study.

The MHRA Inspectorate has published a set of Question and Answers on the import of Investigational Medicinal Products (IMPs) in a blog.

In the aftermath of the PIP scandal (4957), the EU has been planning for a long time a tightening of the rules for medical devices. In future, two regulations for medical devices and in-vitro diagnostics (IVDs) will be created on the basis of the 3 existing guidelines for medical devices (plus a supplement). How does the agreement of the EU look like?

When is a medical device considered a medical device and when isn't it? The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) tries to answer this question in a 12-page guideline. Here you can find a summary of the MHRA guideline "Borderlines with medical devices".

Would the implementation of TTIP bring an end to FDA inspections in the EU? This is discussed in the EU proposal for a respective annex on medicinal products.

In May, the WHO published a draft guideline which describes the recommendations for ventilation systems used in the manufacture of non-sterile dosage forms. It also contains for the first time a definition for microbial requirements with regard to the zones E and F. Read more about the ventilation sytems recommendations.

The Delegated Regulation of the EU has set the deadline for the implementation of the safety features which will be binding as of 9th February 2019. The European Commission has published the summary of a workshop to inform all stakeholders of the recent publication of this Delegated Regulation. Read more about the Workshop on the Delegated Act on Safety Features.