The challenge for quality in manufacturing pharmaceuticals is a constant battle. The need to institute policies, maintain good operating procedures and assure personnel are appropriately trained in all of these is onerous. Taking a risk managed approach adds to this level of complexity even though it helps assure a reduced risk of failure, like a kind of added insurance type approach. All these features are designed to improve quality with the belief that with a greater degree of management oversight there will be a greater degree of accountability, and with that, improved quality performance. And yet if one looks at the number of Warning Letters being issued by the FDA; it is at a record level, which suggests that the strategy is not working. One area which appears to be on the rise is CAPA. Interestingly this is a topic which is constantly on the docket at meetings and conferences as well as the subject of numerous webinars and training sessions. All this suggests the strategy is not working and yet we are all are doing more and more work.

Clearly the intent of the approach is correct, but one must question whether the strategy is correct. Why is it so difficult to reduce and eradicate repeat failures when so many other industries appear to have had a higher level of success in dealing with similar issues? Given that many pharmaceutical consultants have pioneered the transfer of common principles from other process industries, it’s unlikely to lay the blame at the door of the core principles. So, is it how we gather and use that information and ultimately how we are training our staff to process things using that information? Perhaps this lack of standardization and training then is the real culprit.?

With such a fluid workforce, more so than other industries such as aerospace, perhaps the lack of standardization from company to company introduces variability that results in mistakes that are not effectively resolved by existing CAPA systems. It begs the question, is there an opportunity for a standardized training approach that requires actors across the industry to drive this uniformity? This is a radical idea, but until governments and industry trade associations agree on that format and standard, companies will need to rely on pharmaceutical consultants for guidance.