GMP NEWS 2013

The Brazilian monitoring authority ANVISA has integrated an inspection check list to the GMP guideline for medical devices. As these GMP requirements are very similar to the US American ones (21 CFR 820, Quality System Regulations, QSR), this inspection check list may also be useful for companies who want to export in the USA. Read more here.

Have you also always wondered how the FDA gets its guidelines? As concerns GMP documents on the regulation of medical devices the "Device Good Manufacturing Practice Advisory Committee" (DGMPAC) plays an important role. It is the ... read more.

From a regulatory point of view, essential oils used as APIs in herbal products raise a broad range of questions. Currently, there is no EMA/HMPC Guideline on the topic. A "Reflection Paper" from 15 January 2013 invites interested stakeholders to express their opinion. Further details can be found here in the News.

Submitting an application for a centrally authorised product is a complex procedure. Now the EMA has simplified this procedure through new regulations and presented them in an updated guide. Read more here.

Guest Blog: Uday Shetty, Executive Director of Drug Regulations, sees some challenges with India's move to issue Written Confirmations. Read more.

All EU countries are obliged to transpose the requirements of the so-called Counterfeit Directive 2011/62EU in their national legislation. Read more here about the implementation.

In February, the Paul-Ehrlich-Institut published a  notification on "Imposition of conditions pursuant to Section 28 (3) c AMG (Arzneimittelgesetz, German Medicines Act) for the purpose of risk prevention to assure the safety of blood components for transfusion and of stem cell products for haematopoetic reconstitution: Testing for HIV, HBV and HCV". Read more.

The FDA updated the ongoing Chapter 42 - Blood and Blood Products Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001 of the Compliance Program Guidance Manual. Get more details.

One often wonders which differences do exist between the US American cGMP regulations (21 CFR 211) and the EU GMP Guide - and which parallels they have. What's the place for ISO 9001 in these phama specific regulations? In order to support answering the questions, the ECA developed a Good Practice Guide "GMP Matrix" a few years ago. Now, this matrix has been completely revised. Read more.