Purpose This white paper on “how to register a prescription medicine in Australia” provides an outline of the legal and regulatory requirements and processes for obtaining approval to supply prescription medicines in Australia. It outlines the steps to fulfil the requirements for manufacture and supply of the products and provides practical tips on which path…
What is an SOP Effective date? It is surprising how often we review a Standard Operating Procedure (SOP) for a client and the SOP effective date is the same date that QA approved the procedure. With the speed of light, the authorised document has travelled from the QA manager’s desk, was immediately processed by the…
eCTD submissions PharmOut dialed in to listen to the eCTD Introductory Meeting on July the 3rd, which was hosted by the TGA in Canberra and was run by John Bell, eCTD Project Manager, TGA and Kent Briggs, Lead Consultant, eCTD Implementation, from LORENZ Life Science. Kent referred to a lot of information already publically available…
Australia should be proud of its pharmaceuticals manufacturing industry, its a knowledge-based, technology-intensive industry that is arguably essential to continue the development and commercialisation of Australia’s long term investment in medicines and research. Australian industry developments have gained worldwide recognition. They include: CSL’s development of a Swine Flu (N1H1) vaccine Developments in discovering the Gardasil vaccine…
From July 21 2014, clinical trial Sponsors must post results from their trials in the European Clinical trials Database (EudraCT) managed by the European Medicines Agency (EMA) for any interventional trials registered in EudraCT and for clinical trials that have ended within a certain period of time. Voluntary reporting had been encouraged from October last…
All in a twitter about the newest US FDA social media guide? The US FDA have just released a draft US FDA Social Media Guide or guidance on the topic of information sharing via social media platforms that have character space limitations. The document expresses concern for drug advertising via microblogging sites (including Google & Yahoo’s sponsored…
To answer the question, we looked at the fact, on average, as much as 80% of the total energy used by a cleanroom is consumed by the heating, ventilation, and air conditioning (HVAC) system. Up to 50% of this energy is consumed by the fans that provide the high air change rates needed to keep…
A new GDP guide has been published this month by PIC/S – the PIC/S Guide to Good Distribution Practice for Medicinal Products. The PIC/S GDP Guide is based on the 2013 EU Guidelines on Good Distribution Practice.
There are substantial differences between the current Australian requirements and those of the PIC/S Guide to GDP.
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