On 1st of January 2017, revision 13 of the PIC/S Code of GMP for medicinal products (PIC/S PE 009-13) entered into force. Four Chapters of PIC/S PE 009-13 were revised to align with the current EU GMP code and …
Last week, Bob Tribe, who is an Executive Consultant with PharmOut spent the week in Riyadh, Saudi Arabia assisting the GMP Inspections Section of the Saudi FDA get ready to lodge an application for PIC/S membership. This involved a …
In July 2016, the MHRA released a draft document for consultation entitled MHRA GxP Data Integrity Definitions and Guidance for Industry. As the name suggests, it is a glossary of DI terms where the definitions are further explained with …
PIC/S have just released a new, responsive website that allows for easy viewing on both desktop and mobile devices. The website reflects the change from the black and white PIC/S logo to the red, blue and white tones. The …
In its first major revision since the original release in 1999, ISO 14644-1 was updated and approved as an International Standard in October 2015 and published in December 2015. This blog aims to provide a brief overview of the …
In its first major revision since the original release in 2000, ISO 14644-2 was updated and approved as an International Standard in October 2015 and published in December 2015. This blog aims to provide a brief overview of the …
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 …
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 …
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 …
