Qualified Person (or QP) Steve Mather makes sure that medicines used in clinical trials are made according to the schedule, or required method, and used appropriately. This is called “Good Pharmaceutical Manufacturing Practice” (or GMP). QPs observe the entire GMP process, and ensure that the test results on the medicines that are produced confirm that they are made to a high quality standard. They also check a clinical trial’s protocol to make sure that the medicines will be used safely and appropriately.
Steve works across the whole chain of manufacture, as well as with the Principal Investigator, the Research Nurses, and the rest of a clinical trial team to make sure these standards hold. “What’s important in clinical trials is that there be a balance between the desire to improve science and move science forward, but also that whatever we’re using should be as safe as possible for the patient,” he says.
“Whenever a drug is manufactured, if you go to the chemist and buy a drug off the shelf, or if your doctor prescribes a drug for the treatment of a particular condition, then the suitability of that drug will have been assessed by a Qualified Person in the drug industry at some stage in order that it might be made available for general use.”
To become a Qualified Person, you need to be a biologist, chemist, or pharmacist, and a member of a professional body for that profession. You must then pass an exam. Successful candidates join a register of QPs, and clinical trials and pharmaceutical companies can only recruit QPs who are on one of these registers.