PharmOut is Australia’s largest specialist consultancy focusing exclusively on the pharmaceutical, medical device and life science sectors. Usually they are well known for their headquarters which is based in Melbourne, however, PharmOut’s Managing Director, Trevor Schoerie has announced today that the company had just opened a new office in Brisbane in order to meet the increasing demand…
A lighthearted look at the things that can go wrong with a clean room design, right in time for the holiday season. A Christmas gift Yah! Joe had finally gotten approval to build a new clean room as part of the building project he was responsible for. They desperately needed it to make the new…
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…
Data integrity might appear to be a “buzz” word for regulators and management, but as the Volkswagen scandal involving 90,000 cars and the Qantas “tailstrike” incident indicate, it is of paramount importance in all industries. In the pharmaceutical and medical device industries we constantly see similar failings which could have devastating consequences on patients. David…
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,…
Medical Device Data Systems On the 9th February the FDA released the Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (MDDS),’ Guidance for Industry and Food and Drug Administration Staff. The guidance document continues to reflect the FDA’s risk management approach around medical devices developed for patient self-monitoring. In June…
PharmOut is delighted to welcome Grant South to the role of Senior Consultant. Grant is an experienced Project Engineer with over 10 years experience in computer system validation (CSV) and protocol development and execution (FAT, SAT, IQ, OQ, PQ). Grant has implemented a variety of IT systems within regulated environments in accordance with industry compliance…
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