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…

Start by keeping your training management on Pharma/Biotech processes simple So how do we achieve this? Having supported start-up and medium size Pharma/Biotech businesses for several years, the Quality function is a relatively small department and to ensure all staff are trained on their pr…

This is how we would summarise Total Quality Management (TQM) – It’s all about the people! 1) Empower your personnel to take responsibility for what they do. Make them feel valued; 2) Involve the shop floor personnel to create the user requirement specification so you get exactly…