Few people realise that global drug shortages occur everyday. We are talking about essential, life saving medicines that a patient or sick person is missing out on. In Australia, the TGA have a medicines shortages information initiative and a website that provides health professionals and consumers with information about medicine shortages. Currently there are 147 medicines…
Lean Pharma Tips I think everyone has heard of the 7 Lean Manufacturing Wastes, increasingly we hear that an 8th Waste has been added – Skill. Over the years, and with my failing memory, I have learnt that I need an easy way to remember the “wastes”, especially when I’m out front training a class, so my…
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…
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…
As the gap between current EU/PIC/S GMPs and Australian GMPs widens, is the TGA losing relevance? Last week, I was speaking with a respected Senior Quality Executive from a leading Australian pharmaceutical manufacturer, I was surprised when they stated that they no longer prioritised TGA inspections or findings. This is in stark contrast with my…
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