What is the current number of medicinal cannabis prescriptions in Australia so far? In just a few years, the number of medicinal cannabis prescriptions through the Special Access Scheme B (SAS-B) has grown substantially. It still represents a small percentage of the overall Australian population who state they rely on cannabis for medicinal purposes. Only…
We are proud to say that PharmOut is now a carbon neutral practice, in doing so reaffirming our commitment as a sustainable global consultancy practice. As a means of continuous improvement, this continues to prepare us for the challenges that face us in the responsible design and operation of buildings in working to reduce carbon…
In this blog I would like to share my 10 tips for writing user friendly SOPs as part of your GMP Pharmaceutical Quality System. The other day I was informed by a client that no-one on their site reads procedures and the only function SOPs performed was ticking a compliance check-box. In my experience this…
Clinical Evaluation EU-MDR requirements This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR [Regulation (EU) 2017/745]. What is meant by the term ‘clinical evaluation’ in the EU MDR? The EU Medical Device Regulation (EU MDR) defines clinical evaluation as “a systematic and planned…
Once the Pharmaceutical Quality System (PQS) (as per ICHQ10: Pharmaceutical Quality System) is implemented, it must be ensured that it continues to be effective, and for this to happen there has to be a clear commitment from senior management to a Quality Culture. There are several ways senior management can demonstrate their commitment to the…
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