This is the second of a two-part blog covering the changes to PIC/S version 16. Previously we discussed changes to Annex 13 – Manufacture of Investigative Medicinal Products, and today I am doing a comparison of the new Annex …
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, …
“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 …
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 …
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 …
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 …
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 …
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 …
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, …
It has been a big year for industry as organisations scramble to be in full compliance with PIC/S PE009-13. With the due date on January 1st 2019, this deadline is coming sooner than many of us would like!
On the …
