As the gap between current EU/PIC/S GMPs and Australian GMPs widens, is the TGA losing relevance? Last week, I was speaking with a respected Senior Quality Executive from a leading Australian pharmaceutical manufacturer, I was surprised when they stated that they no longer prioritised TGA inspections or findings. This is in stark contrast with my…
1. Over 70% of world drugs are produced in PIC/S GMP facilities (member countries or companies) With the US FDA joining PIC/S in 2011 and many other agencies in the queue, compliance with the PIC/S GMP regulations should be a priority for any pharmaceutical manufacturer exporting to multiple countries. I heard recently that countries where…
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.
Dedicated Facilities Last week, I published a blog titled “Dedicated facilities or not?” and I surmised that trying to guess where regulations on cross-contamination were going, it was like gazing into a crystal ball. Well, the crystal ball was in Paris two weeks ago where 156 participants from 56 countries met on the topic of…
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.
To answer the question, we looked at the fact, on average, as much as 80% of the total energy used by a cleanroom is consumed by the heating, ventilation, and air conditioning (HVAC) system. Up to 50% of this energy is consumed by the fans that provide the high air change rates needed to keep…
A new GDP guide has been published this month by PIC/S – the PIC/S Guide to Good Distribution Practice for Medicinal Products. The PIC/S GDP Guide is based on the 2013 EU Guidelines on Good Distribution Practice.
There are substantial differences between the current Australian requirements and those of the PIC/S Guide to GDP.
Japan and Korea join PIC/S PharmOut congratulates the MHLW and the PMDA of Japan’s Prefectures and Korea’s MFDS on being invited to join PIC/S as of the 1st of July. This will mean we have 46 participating authorities, not sure how these fits with the recent Dr Margaret Hamburg talk in London to the MHRA…
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