The first references to the term “dedicated facility” appeared in GMP literature in the early 2010s in response to potential cross contamination risks of manufacturing toxicologically sensitive products in shared facilities. The WHO Technical Report Series, No. 957, 2010 …
Virtual Qualification, how can Pharma 4.0® thinking help during Covid-19 lockdown and what lessons can we apply to virtual qualification?
The events of Covid-19 have opened up a new world of vulnerability to all industries, and especially those highly regulated …
Quality Management System software providers have matured in recent years, with an increasing number entering the Pharmaceutical and Medical Device industries and marketing themselves as 21 CFR Part 11 and ISO 9001 compliant.
The fact is that QMS software providers …
Medical Device Consultants
Engineering related medical device consultants can come from a lot of different areas. These span from science degrees like microbiology and physics, innovation degrees such as product design and implant design and also a range of engineering …
GACP – GMP Cannabis Consultants in the Cannabis Industry
Great GACP – GMP cannabis consultants are hard to find in this high growth cannabis industry which seems to be expanding each month. There is an enormous amount of paper work …
This week we feature a guest addition by Jim Plamondon, VP of Marketing for Thai Cannabis Corporation in Chiang Mai.
As a driver for change, his focus is on turning Thailand into a ‘platform for innovation’ in the emerging legal …
After a number of years pondering and specifying desiccant dehumidification methods in traditional pharmaceutical facilities, we believe that desiccant dehumidification in marijuana greenhouses should be more favourably considered.
In our previous experiences designing large marijuana greenhouses, we have found that …
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 its costs for all activities …
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 …
Containment Control Strategy
A robust containment control strategy is essentials as a growing number of pharmaceutical products contain highly potent active pharmaceutical ingredients (HPAPIs) that are capable of targeting disease selectively and more precisely than other compounds. HPAPIs are more …
