GMP NEWS 2017

In his talk on "Detection of Falsified Medicines and how the QP can support this", Paul Hargreaves (MHRA), explored some facts that a QP should know when it comes to the falsification of medicines.

After the second public consultation for the EMA Guideline on GMP for Advanced Therapy Medicinal Products there are still uncertainties and a persisting need for discussion of the current regulatory requirements.

Yes, it is! As you can see in a recent case from Denmark, where the Danish Medicines Agency requires that the CEO of a repackaging facility needs to be replaced.

A Stimuli article on the proposed new USP General Chapter <1220> has been published in Pharmacopeial Forum 43(1) [Jan.-Feb. 2017]. Read more about the "The Analytical Procedure Lifecycle".

The EMA published a refelection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs. It is part of the EU strategy that principles of Replacement, Reduction and Refinement must be considered systematically at all times when animals are used for scientific purposes in the EU.

In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the differences between the draft and the final version of the FDA Guideline for Combination Products?

The manufacturer of APIs and medicinal products Wockhardt in India received an FDA Warning Letter at the end of December 2016. During the inspection, it had been observed that both in GC and HPLC analytics OOS results were excluded from the official records. Get more information about the current Wockhardt FDA Warning Letter.

The IMDRF (International Medical Devices Regulator Forum) is the successor organisation of the Global Harmonisation Task Force (GHTF). Recently, the IMDRF has published a guidance draft entitled "Software as a medical Device (SAMD): Clinical Evaulation".

In irregular intervals, the ECA publishes overviews over new guidances or draft guidances, webinars, general strategy papers and inspection outcomes of the FDA with regard to medical devices. Find out more in the selection of FDA publications of the last months.