Blogs

pics tablets

PIC/S GMP version 14 major changes

Finally that minor typo in Chapter 9 has been fixed; its been a frustrating 10 years! Now that’s off my chest, we can look at the main changes between PIC/S GMP PE 009 version …

medicinal cannabis greenhouse

Medicinal Cannabis Manufacturing Training Course

After helping multiple clients to successfully navigate through the Office of Drug Control (ODC) licence application process, as well as assisting a client to obtain the first successful TGA GMP manufacturing license for Medicinal Cannabis, …

Medicinal cannabis

Export of Medicinal Cannabis from Australia

In January 2018 the federal health minister announced that, after industry consultation, the export of Medicinal Cannabis from Australia would now be permitted.
Subsequently, the export of Medicinal Cannabis products was legalised in February 2018 …

FDA Metrics tracker

Updated FDA 483 citations analytics tool

As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a supply and just in time, QikSolve have …

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 …