FDA light touch on medical devices for patient self monitoring

PIC/S PE 009-16 update, Part 1 – changes to Annex 13

Historically, the PIC/S GMP Guide has chapters and annexes revised, aligned and corrected to close the gap between the international GMP guidelines and to further develop and harmonise GMP standards. PIC/S PE 009-16 (or version 16) of the Guide, …


Passive Packaging – Lessons Learned

“We’ve got a new project for you. We’re going to replace our cold-chain account with passive packaging.”

It’s a notion I’ve heard many times before, but I will admit to having to abandon more passive packaging projects than I’ve completed …


TGA Medicinal Cannabis

I’m often asked to clarify the difference between TGA Medicinal Cannabis and EU GMP Medicinal Cannabis, i.e. who is that has the highest “Gold Standard” for Medicinal Cannabis? I suspect this has come about because many are trying to …


Benefits of PIC/S Membership for Regulators and Industry

On 1 January 2021, ANVISA, Brazil became the 54th member of PIC/S. Like all other PIC/S members, both ANVISA and Brazil’s pharmaceutical industry will realize a wide range of benefits of PIC/S membership, particularly at this time of the …

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 …


Serialisation Requirements in the Pharmaceutical Industry

Supply chains for pharmaceutical manufacturing and medical device production are becoming increasingly complex. Medications, from source to shelf, now involve numerous networks and cross the borders of many different countries around the globe. Serialisation requirements in the pharmaceutical industry …


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 …


Good Documentation Practices (GDocP) | GMP Basics

GMP Basics of Good Documentation Practices (GDocP)
Good documentation practice (GDocP) is a crucial component of GMP compliance.

More frequently referred to as Good Recordkeeping Practice, good documentation practices are not only helpful during a regulatory inspection (GMP audit), non-conformance/deviation investigation, …