The practice of making true copies of thermal paper. Last week I was asked an interesting question relating to making true copies of thermal paper. We all copy thermal paper but the question was: ‘Where does it say that in the regulations that this needs to be done?’ One of the challenges when training new…
On the 30th of March, the EU released its updated version of Annex 15 Qualification and Validation which will be effective on 01 October 2015. In this article, I will discuss the changes between the draft version and the revised Annex 15 version.
GMP Annex 1 – sterile manufacture In January PIC/S and the GMP/GDP Inspectors Working Group (on behalf of the EMA) agreed on a concept paper regarding the long awaited update to Annex 1, the primary GMP guidance on sterile manufacturing for Europe and PIC/S member countries. The current version of Annex 1 dates from 2007,…
Only a brave person would try to guess where the EU GMP regulations are going for medicinal products produced in shared manufacturing facilities. At the moment, it is a little like gazing into a crystal ball, trying to understand the consensus of the many participating authorities involved, with their often strongly differing views based on their in-country experiences (disasters). Existing facilities really only have “Organisational Measures” to control the potential risks of cross-contamination, as often it is impractical to retrofit the “Technical Measures” as referred to in Chapter 3 and 5 in the EU GMP guidance.
A number of very important changes are taking place within the EU GMP guideline, with key chapters in the Eudralex Volume 4, Part 1 under revision.
From July 21 2014, clinical trial Sponsors must post results from their trials in the European Clinical trials Database (EudraCT) managed by the European Medicines Agency (EMA) for any interventional trials registered in EudraCT and for clinical trials that have ended within a certain period of time. Voluntary reporting had been encouraged from October last…
This White Paper explores the methods of preventing contamination and cross-contamination in manufacturing facilities. Purpose To identify potential contributors of contamination and cross contamination. To offer ideas on how to minimise and prevent contamination and cross contamination occurring within a manufacturing facility. Audience Project Managers Validation professionals QA professionals Prerequisites Familiarity with Annex 15 Qualification…
Purpose This White Paper reviews the proposed changes to Annex 15 of the EU GMP guide in detail. The draft of the revised Annex 15 was released in February 2014 by the European Commission. The draft version is based on an EMA Concept Paper that was published in November 2012. A review of the Concept…
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