The Good Distribution Practice Challenges in Wholesaling & Freight Forwarding of Medicines The Responsible Person or Responsible Pharmacist, as referred to in some parts of Europe, is the person identified for ensuring the quality and safety of the medicinal product within their supply cha…

In my view, it is not acceptable to refer to any Change as temporary. You either Change or you don’t. It should be a well-structured and controlled Change from start to finish. I accept, we may face exceptional situations as in the above illustration, where a very immediate fix must be made.…

The process flow below provides simple guidance to anyone wishing to learn about how Pharma/Biotech suppliers should be managed where they have an impact on the medicinal product. Any outsourced services provider, should be considered as an extension of your business and they must comply with…

Over the years and working across different companies within the Pharmaceutical and Biotech industry, I have come across Quality Management Systems (QMS) which have become top heavy and cumbersome to work with – the response when digging further is “well if it’s not broken” – i…