Clinical quality management system
Quality management systems (QMS) are used in many industries to create a framework for defining and delivering quality outcomes, managing risk, and continual improvement. Many guidelines and governance bodies have been established to ensure a common approach within a given industry to a set of parameters used to identify the minimally acceptable standard for that industry. The pharmaceutical industry is no exception, with several trade groups (e.g. PhRMA, EFPIA, RQA, etc.) coming together to enhance collaboration. However, as noted by the Academy of Medical Sciences, there are increasingly complex and bureaucratic legal and ethical frameworks that innovators must work within to develop new medicines for patients. 1
The historical pharmaceutical QMS applies primarily to good manufacturing practice as described in existing ISO (International Organization for Standardization) and ICH (International Committee on Harmonization) guidelines. “Good Manufacturing Practices (GMP) relate to quality control and quality assurance enabling companies in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the customer from purchasing a product which is ineffective or even dangerous.” 2
These standards have historically been applied to the manufacturing environment, appropriate to how they have been written. However, according to FDA as well as other regulatory bodies, “Pharmaceutical Quality Systems (ICH Q10) applies to drug substance and drug product throughout product lifecycle and provide tools to facilitate continual improvement”3, implying that the same standards that apply to the manufacturing environment should also be applied to the clinical research space, earlier in the lifecycle of an investigational or marketed product. Accordingly, a CQMS is any system developed to apply these principles to clinical operations within an organization.
1 – Academy of Medical Sciences. Strengthening clinical research. Report of an Academy working group. London: AMS, 2003. www.acmedsci.ac.uk 2 – http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref998 3 – Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 27, 2011 – Moheb M. Nasr, Ph.D., Office of New Drug Quality Assessment, OPS/CDER/FDA