Congratulations Colin Byrne
PharmOut is delighted to announce that Colin Byrne has been promoted to the role of Senior Consultant.
Colin has over 12 years of experience in the pharmaceutical industry, including more than 4 with …
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 …
One of the four approved pathways to supply Medicinal Cannabis in Australia is via Medicinal Cannabis Clinical Trails under the CTN scheme. This blog discusses this route in greater detail.
The use of Medicinal Cannabis …
For large Medicinal Cannabis greenhouses, you typically need a large flat area with a fall of less than 1 in 400 (making all airports prime Medicinal Cannabis cultivation sites). Recently, there was an article …
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 …
Every year the TGA undertakes a comprehensive targeted consultation by engaging with peak therapeutic industry bodies in regard to the fees and charges proposal for the upcoming financial year.
The TGA is required to recover …
Medicinal Cannabis cultivation has been a hotly discussed topic in Australia ever since cultivation was made legal in October 2016. The industry has been buzzing with new ideas, initiatives and investment as well as …
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 …
New partnership offers cost-effective paperless validation to GMP – governed organisations in Australia.
PharmOut, the Asia Pacific’s leading Pharmaceutical consulting organization, has announced a strategic partnership with ValGenesis Inc, a pioneer in paperless validation software …
The time has come for us to talk about the Data Integrity elephant in the GMP room. Despite Data Integrity being a hot topic in industry for the past 5 years, it continues to …
