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 …
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 …
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 …
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 …
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 …
Good Documentation Practices (GDocP) | GMP Basics
GMP Basics of Good Documentation Practices (GDocP)
Good documentation practices (GDocP) are key components of GMP compliance. Good record-keeping not only helps you during regulatory inspections (GMP audits), it is mandatory to ensure your documentation …
Putting the “Good” back in “Good Laboratory Practice”
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 …
PIC/S GMP version 14 major changes
Finally, that minor typo in Chapter 9 has been fixed; it has been a frustrating 10 years! Now that’s off my chest, we can look at the main changes between PIC/S GMP PE 009 …
PIC/S update to PE009 – version 14 on its way
In a recent press release, the PIC/S Committee recently announced the revision of the PIC/S GMP Guide (PE 009) to PIC/S version 14, with updates to:
Chapter 3 – Premises and Equipment
Chapter 5 …
PIC/S – New Draft Annex 1 – Part 8 of 8
The final part of the blog series looks at Chapter 10 (Quality Control) and the glossary. In addition, we say goodbye to small number of clauses which have been removed between the 2007 and …