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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 …

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, …

Clean Room Designers

PharmOut is a multi-disciplinary team of expert pharmaceutical architects and engineers, we are Australia’s leading pharmaceutical clean room designers, working for cosmetics manufacturers, non sterile and sterile pharmaceutical manufacturers around the world to provide …

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 …