Janet Woodcock from the FDA has published a very interesting report in the Nature Publishing Group. As leader of the CDER, she has one of the most important positions within the FDA.
In her report entitled "Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages" she highlights the issue of shortage of many medicinal products (mainly sterile products from generics companies). According to her, such shortage is often caused by economic optimisation reasons from companies and the fact that they have a few – and sometime even only one site which delivers one product to the market. Now, the FDA has observed considerable GMP deviations during inspections at some of those sites which have been temporarily closed.
In the course of these analyses, the FDA has noticed that to keep costs down in the production quality isn’t really taken into consideration. The article concludes that there is no reward for good quality. There exist only two quality levels: "Compliance" or "Non-Compliance".
Janet Woodcock and her co-author put the introduction of "Quality Metrics" up for discussion as it is used in other branches. For example: AAA could correspond to 100% GMP conformity, BBB to lower quality and C and D to Non-Compliance.
An interesting thought which shows that authorities are thinking of new ways to make of GMP a top priority topic for the top management. Dr Jean-Denis Mallet (former head of the French GMP inspection authority and ECA Board Member) will talk about this topic at the 5th European GMP Conference in Heidelberg. More details can be found at www.gmp-conference.org.