PIC/S

Annex-2B-Biologicals

Annex 2B – Manufacture of Biologicals under GMP PE009-015

PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update splits Annex 2 into Annex 2A: Advanced Therapy Medicinal Products and Annex 2B: Biological Medicines separately:

Annex 2A: Manufacture …

annex-2a-manufacture-of-atmps-pics

Annex 2A – Manufacture of ATMPs under GMP PE009-015

PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update separates Annex 2 into advanced therapy medicinal products (ATMP) and biological medicines, as follows:

Annex 2A: Manufacture of …

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

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

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

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

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 …