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…

The Q is Quality stands for Questioning. As a good auditor, not only should you be asking the appropriate questions, you also need to have the right technique in asking questions. Below are my 10 tips to surface the facts where things have gone terribly wrong or where improvements can be made.…

The below process flow was created for one of our CGT clients based on a process mapping exercise to help understand that there are numerous lines of investigation that need to be performed immediately once a positive unit is identified during an aseptic process simulation (APS). This is no no…