PIC/S

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

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 …

pupsit

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-v-gdp-pharma

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 …

pics tablets

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 …

Quality Risk Assessment

PIC/S – New Draft Annex 1 – Part 7 of 8

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”. …

Quality Risk Assessment

PIC/S – New Draft Annex 1 – Part 6 of 8

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 …