Category Archives: Publication

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…

Having been an auditee and an auditor, I have seen how difficult we can make it for the auditee. My top 2 words of advice would be to BE KIND. As an AUDITEE, we know that there are gaps in our processes and sometimes we are just not given the time or resource to have these resolved. My advic…