Blogs

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, PharmOut has earned the enviable …

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 through the Narcotic Drugs Amendment …

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 the good distribution practice for …

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 2017 versions of Annex 1.

Readers …

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”. In addition to the 21 …

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 and related sterilising processes. “PIC/S – …

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 size, as it is by …

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, steam and compressed gas systems. …

Quality Risk Assessment

PIC/S – New Draft Annex 1 – Part 3 of 8

In Part 3 of the blog series on the draft revision of Annex 1, we look at chapters 5 and 6, on the subjects of Premises and Equipment respectively.

Readers may also wish to view the Initial Blog, Part 1 and …

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 beyond), we will use categorization …