Quality Risk Assessment

New Draft PIC/S Annex 1 – Part 2 of 8

Continuing our blog series into the new draft PIC/S Annex 1 revision, (see part 1 here), part 2 looks at Chapters 3 & 4. As we move into the detailed chapters (chapter 4 and …

Quality Risk Assessment

New draft PIC/S Annex 1 – Part 1 of 8

This is part 1 of a series of blogs which will address the draft annex 1 in full. This series will be presented over the next few weeks, with a focus on individual chapters. …


Potent Pharmaceutical Drugs – Containment Control Strategy

 Containment Control Strategy
A robust containment control strategy is essentials as a growing number of pharmaceutical products contain highly potent active pharmaceutical ingredients (HPAPIs) that are capable of targeting disease selectively and more precisely than …

Fake news? Media claims the WHO has declared cannabis safe

As a participant in Australia’s medicinal cannabis “phenomenon” I have been very impressed with the rigorous, evidence-based approach the government and the industry have taken to regulating the product. I’ve also been astonished by …

GMP vs cGMP - what's the diffrence?

GMP vs cGMP – what’s the difference?

I’m often asked “What is the difference between GMP vs cGMP – are they the same? Is one a subset of the other?”

At the most basic level, GMP stands for Good Manufacturing Practice and …

overcoming regulatory hurdles

Entrepreneurs’ Programme Learning Event

Free Learning Event – Overcoming Regulatory Hurdles for Medical Devices
The Entrepreneurs’ Programme Learning Event on Medical Devices brings together two experts in the field that will be able to assist SMEs to understand from …

Sue MacLeman MTPConnect

Australian-first Manufacturing and Hands-on Training Facility

Australian-first manufacturing and hands on training facility to produce medical products for early stage human clinical trials receives funding from MTPConnect’s Project Fund Program
PharmOut is proud to partner with these prestigious Australian organisations and …

PIC/S GMP Documentation Tips

What you need to know about PIC/S GMP Documentation
The TGA’s announcement of its intention to adopt PIC/S GMP PE 009-13 as of 31 December this year means Australian GMP manufacturers need to review their …

New PIC/S GMP PE009-13

The New PIC/S GMP Version 13 is finally here and it’s all about the people!

I have a specific interest in what is in the new PIC/S GMP, for example, Chapter 2 (Personnel), it expands and …