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 …
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 …
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 …
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 …
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 …
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 …
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 …
This chapter contains information which was previously covered under the headings “Clean Room and Clean Air Device Monitoring”, and also clauses 66-69 on Aseptic Process Simulation (APS) which was under the old heading “Processing”. …
As noted in Part 5 of the blog series on the draft revision of Annex 1, Parts 5 & 6 look at Chapter 8 (Production & Specific Technologies).
Part 5 focussed on terminal sterilisation of products …
Parts 5 & 6 of the blog series on the draft revision of Annex 1 looks at Chapter 8 (Production & Specific Technologies). The chapter has been separated into two blog posts due to …
