GMP NEWS 2018

In October 2017, the ICMRA adopted recommendations on the implementation of Track and Trace (T&T) Systems to emphasise the importance of the complexity of these systems. This is relevant for regulatory authorities as well as for the pharmaceutical industry. Find out more about the ICMRA T&T recommendations.

The UK Government recently confirmed that it is committed to implementing the EU CTR into UK law to the extent possible after Brexit.

The EU Data Protection Regulation will apply from May 25, 2018. It will introduce new data protection requirements in the EU as well as substantial fines for breaches of the data protection rules. Read more about impact of the new EU Data Protection Regulations on clinical trial and pharmacovigilance activities.

The European Medicines Agency (EMA) has updated its Questions and Answers Section with an amendment to further clarify the role of the QP in the context of handling unexpected deviations.

The PIC/S and the US FDA have set up a seminar to show inspectors how to assess Quality Risk Management implementation in industry.

Despite the currently discussed "transition period", the European Medicines Agency (EMA) has emphasised that industry should be well prepared even for a so-called "hard Brexit.

The "How to do" document is one of APIC's many Best Practices Documents and has been upgraded to the current state of the art. Read here which practical recommendations in the implementation of GMP for APIs are included in the most recent version of the How-to-do document.

In March 2018, the FDA has issued a Warning Letter to a manufacturer of medicinal products in the Dominican Republic due to various GMP violations. One of these violations was cross contamination.

Ph. Eur. chapter 2.9.20 on the visual control of parenterals is currently being revised. There are no major changes expected. What is much more interesting is the announcement of a new advising chapter. Read more about the new chapter 5.17.2 on visual inspection.