PIC/S have just released a new, responsive website that allows for easy viewing on both desktop and mobile devices. The website reflects the change from the black and white PIC/S logo to the red, blue and white tones. The layout of the site is more intuitive and new sections include members only access to the…
A Better Australian Pharmaceutical Manufacturing Industry by Design – the National GMP & Validation Forum We were thrilled to have this years Validation Forum opened by the Honorable Mr Frank Maguire, Member for Broadmeadows. Frank said that he “wanted to be remembered the rise of CSL, not the demise of Ford”. This statement resonated with every one…
Within the last 30 days, the US FDA released two new Warning Letters and yes-you guessed it, all contain data integrity violations. Lets look them below: Falsifying test data from a stability batch The latest Warning Letter is to an API manufacturer who acknowledged to the inspector during the inspection that a laboratory analyst substituted a reference…
Do I really need ISO 13485:2016 certification? There has been rapid growth in the area of custom-made medical devices, made for single known, patients and this has led to the authorities issuing additional guidance. Innovative companies around the world are producing devices and drugs such as Anatomics and Aprecia* using technologies such as 3D printing. *Note: In March 2016,…
Brexit causes questions to arise as to the future of the EMA, located in Canary Wharf, London and also about MHRA’s continued contribution to the regulatory control of drugs in the European Union (EU) following the recent Brexit, referendum in which the UK voted to leave the EU. The reality is probably that nothing will…
Are you innovative? We have too many people sitting about complaining about our shrinking Australian manufacturing industry, but you can do something about it! I have always believed that you must build in quality. For example with the US FDA 3 stage validation approach: we have realised that quality must be designed into the product. How…
PharmOut recently developed a free ISO 13485:2016 Gap Analysis tool for identifying the gap between the ISO 13485:2016 and ISO 13485:2003, currently this tool is free to all clients attending our ISO 13485:2016 Medical Device training, or anyone that may have previously purchased our ISO 13485:2003 QMS templates since the 1st January 2016. The latest…
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…
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