Quality Risk Assessment

PIC/S – New Draft Annex 1 – Part 6 of 8

As noted in Part 5 of the blog series on the draft revision of Annex 1, Parts 5 & 6 look at Chapter 8 (Production & Specific Technologies).
Part 5 focussed on terminal sterilisation of products …

Quality Risk Assessment

New draft PIC/S Annex 1 – Part 5 of 8

Parts 5 & 6 of the blog series on the draft revision of Annex 1 looks at Chapter 8 (Production & Specific Technologies). The chapter has been separated into two blog posts due to …

Quality Risk Assessment

New Draft PIC/S Annex 1 – Part 4 of 8

In Part 4 of the blog series on the draft revision of Annex 1. We look at Annex 1 Chapter 7 (Utilities), which provides guidance unique to supporting process services, such as water, vacuum, …


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 …

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 …

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 …