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 changes, but more importantly, how the changes affect the current PIC/S Guide to GMP for Medicinal…
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…
A day in a PharmOut consultant’s life I’m often asked what a typical PharmOut day entails. After recently hearing from one of our consultant’s partners, that they were completely amazed when he told her what he did each day: “Surely you don’t do that?”, “I did not know that PharmOut does that!”, I decided to…
Today PharmOut’s Managing Director, Trevor Schoerie, announced that PharmOut has opened an Adelaide office at Level 3, 97 Pirie Street. PharmOut has a proud track record over the years of helping local South Australian manufacturers, pharmacies and hospitals in the GMP and validation area. “By having a local Adelaide presence, we are able to effectively meet our current…
Be the first in the know. Join our devices expert Seamus Orr in Melbourne and Sydney for ISO 13485 : 2016 Training Course Some regulatory and standard version updates are anticlimactic – years of review and then the key changes are semantics that leave manufactures still pondering intent. This is not the case for ISO…
Fast facts about the Australian Complementary Medicines Industry: Has grown from $2.3 billion to $4.2 billion in just 2 years.* 6,000 direct high value jobs.* Exports to more than 26 countries.* 75 licensed complementary medicines manufacturers. In a recent interview Mr Carl Gibson, Chief Executive Officer Complementary Medicines Australia, said “Over the last two years we have seen…
How familiar are you with the common concepts of GMP? If you feel you are up to the challenge, test your knowledge by taking the GMP Quiz Master challenge, if you are brave enough, login and leave your details, or you can do the test anonymously. Want to read “The story of Joe and his…
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…
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