Data Integrity The Parenteral Drug Association (PDA) recently released a free “Points to Consider” document to members that outlines a number of key elements that would make up a “Code of Conduct” for Data Integrity (DI) within the pharmaceutical Industry. The document was created as a result of collaboration of PDA members as part of…
Another Major Milestone for Vaxxas’ Revolutionary Vaccine Delivery Platform. Queensland-based Biotech company Vaxxas certainly embodies the Australian Government’s innovation strategy – “the ideas boom”. Their Nanopatch™ product is an innovative vaccine delivery platform, with many exciting benefits over traditional delivery methods, perhaps most notably in the developing world, who are rarely the early beneficiaries of…
RO Water for Injection? Allowed by the European Pharmacopoeia from April 2017? The European Pharmacopoeia Commission recently announced the revision of monograph 0169 to allow for generation of EP Water for Injection (WFI) “by a purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques”. These changes will align the EP with the…
The BioMelbourne Network event on Wearable Medical Devices and Diagnostics that PharmOut attended in Melbourne on March 17th certainly confirmed the two directions that wearables and wearable devices in medical technology are currently taking. On one path are devices and apps that residue in a “pre-diagnostic world”, supplying users with information on sport and fitness,…
This is a historical document describing the Top 10 FDA Warning Letter Findings for finished pharmaceuticals in the Year 2015. After reviewing the 27 warning letters issued for finished pharmaceuticals in 2015 (a decrease from the 33 issued letters in 2014) the following top 10 hit list has been assembled. #10 Subpart J: Records and…
The FDA issues warning letters as formal notifications to industry about violations that the FDA has documented during an inspection or investigation. The warning letters are publicly available on the FDA website. Reviewing the letters for finished pharmaceuticals is a powerful training tool and provides an insight into non-compliance trends occurring across finished pharmaceutical manufacturing….
Pharmaceutical manufacturers and other organisations operating under GMP-regulations have been hesitant to adopt cloud-based IT solutions. This is usually because they want to retain their data within their own four walls and because of the difficulty in maintaining the validated state of cloud-based software that can be updated without warning by the vendor. However, there…
In its first major revision since the original release in 1999, ISO 14644-1 was updated and approved as an International Standard in October 2015 and published in December 2015. This blog aims to provide a brief overview of the changes, but more importantly, how the changes affect the current PIC/S Guide to GMP for Medicinal…
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