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Entries by Trevor
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PIC/S GMP version 14 major changes

Finally that minor typo in Chapter 9 has been fixed; its been a frustrating 10 years! Now that’s off my chest, we can look at the main changes between PIC/S GMP PE 009 version …

medicinal cannabis greenhouse

Medicinal Cannabis Manufacturing Training Course

After helping multiple clients to successfully navigate through the Office of Drug Control (ODC) licence application process, as well as assisting a client to obtain the first successful TGA GMP manufacturing license for Medicinal Cannabis, …

Good Distribution Practice (GDP) – can we do more?

When good drugs turn bad and how Good Distribution Practice can help
I’m currently involved in the implementation of the regulatory controls around medicinal cannabis in Australia and eventually we will need to work out …

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 …

Pharma 4.0 – How Industry 4.0 Impacts in Pharma

A lot has been written on Big Data and the Industrial Internet of Things (IIot), also known as Industry 4.0, and how it’s changing the face of industries like transportation and logistics, manufacturing, aviation, …

Quality Risk Assessment

In Australia, a Quality Risk Assessment is now a regular GMP activity since we saw the introduction of PIC/S Version PE 009-08, in 2009 (read more here) and the massive impact, especially of the two …