Why eLearning Solves the Manufacturing Training Dilemma.

Why eLearning should be part of your regulatory compliance training programs — including during a pandemic.
The GMP eLearning Business Case
When we consider why eLearning is a valuable addition to GMP training programs, the following concepts come to mind: accessibility, …

TGA Regulatory Affairs Consultants

PIC/S GMPs vs WHO GMPs – what’s the difference?

As many are aware, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) develops and provides standards and guidelines for the harmonisation of Good Manufacturing Practice(GMP) in the global pharmaceutical industry.
Those who fall under the umbrella of participating countries, often take for …


Form Use – the right way to fill in a form

Following on from the previous blog Form Design – it’s all about the white space, comes the exciting part deux: Form Use – the right way to fill in a form.
There is a general misconception that data integrity failures …


Form Design – It’s all about the white space


That sent a shiver down your spine, didn’t it?

Because it’s longwinded, boring, complicated, sometimes unintelligible, and usually frustrating. Plus, there’s that added frisson from the fear of imprisonment due to unintentional tax fraud.

Form design might seem like a banal …


GMP Documentation – Top Tips for Writing User-friendly GMP Documents

Good documentation (and well-written procedures) is key to achieving compliance with GMP requirements. GMP documentation should include enough ‘instructional detail’ to ensure that processes are well understood and user friendly, and should be ‘…designed, prepared, reviewed, and distributed with …


Circular Project Management – The Right Management Spin

Circular Project Management sounds like it could very well reflect the real-life processes that take place during the life cycle of a new venture. Sometimes, designing and building manufacturing facilities can feel a bit like you’re on a merry-go-round.

“Round, …


Pre-use Post Sterilisation Integrity Testing – PUPSIT

What is Pre-use Post Sterilisation Integrity Testing (PUPSIT)?
PUPSIT stands for pre-use post sterilisation integrity testing. PUPSIT is performed once your sterilising filter is installed to ensure that the sterilisation and installation process has not damaged your sterilisation filter prior …


5 Things to Know About MDSAP in 2020

What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements of the pilot program in …

good distribution practice (GDP) pharmaceuticals

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 the good distribution practice for …