GMPs

vial-inspection

5 Things to Know About MDSAP in 2019

What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements …

good distribution practice (GDP) pharmaceuticals

Good Distribution Practice (GDP) – can we do more?

When good drugs turn bad and how Good Distribution Practice can help
I’m currently involved in the implementation of the regulatory controls around medicinal cannabis in Australia and eventually we will need to work out …

Quality Risk Assessment

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 …

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 …

Quality Risk Assessment

New draft PIC/S Annex 1 – Part 5 of 8

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 …

Quality Risk Assessment

New Draft PIC/S Annex 1 – Part 4 of 8

In Part 4 of the blog series on the draft revision of Annex 1. We look at Annex 1 Chapter 7 (Utilities), which provides guidance unique to supporting process services, such as water, vacuum, …

Quality Risk Assessment

New Draft PIC/S Annex 1 – Part 2 of 8

Continuing our blog series into the new draft PIC/S Annex 1 revision, (see part 1 here), part 2 looks at Chapters 3 & 4. As we move into the detailed chapters (chapter 4 and …

Quality Risk Assessment

New draft PIC/S Annex 1 – Part 1 of 8

This is part 1 of a series of blogs which will address the draft annex 1 in full. This series will be presented over the next few weeks, with a focus on individual chapters. …