GMP NEWS 2013

With this guidance, the FDA addresses blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture. Read on.

The United Kingdom has established a webpage about the Directive on the prevention from falsified medicines ("Falsified Medicines Directive"). Read more here about the information contained on this page and learn why it is important to visit it.

Since the nineties, cleaning validation has been one of the main validation topics discussed by the pharmaceutical industry and API manufacturers. Because of growing globalisation, countries in East Asia (Tiger States and Panther States) have also become interesting as consumer countries of APIs and/ or medicinal products. What about requirements on cleaning validation there? Read more here.

The EMA has published a Q&A document to clarify the questions still open with regard to the "detailed guidelines on procedure issues and the classification of variations" associated to the Variations Regulation. Read more here in the News.

In our News from 11 September 2013, we reported about FDA's initiative to identify production sites according to a  uniform system. The topic seems to be crucial for the FDA as it has now released the draft of a "Guidance for Industry" entitled ... Read on.

Ph. Eur. Chapter 5.20 on metallic impurities won't become legally binding until further notice. Read more about the background and the connection with the new ICH Q3D Guideline.

How to apply for a second or third additional Certificate of Suitability for the same API? The EDQM has released a guideline on the topic. Read more about how the so-called "Sister File" procedure works.

The FDA has published a document with 30 questions and answers to clarify some issues regarding the stability testing of generic products. Read more here about the stability data required for ANDAs.

In May, the Committee for Medicinal Products for Human Use (CHMP) adopted the Guideline on Quality of biological active substances produced by transgene expression in animals. Read more.