GCP Inspectors Need to be Highly Qualified, Says EMA
[Posted on: Thursday, September 3, 2015]
The European Commission (EC) released an opinion article last week highlighting its expectations on the minimum standards of qualification of GCP inspectors, in particular regarding their education and training. Per the EC, an inspector must have university level education in medicine, pharmacy, pharmacology, toxicology or other fields relevant to Good Clinical Practice principles. In addition, the inspector must be appropriately trained in inspection processes, both theoretical and practical, and periodically assessed for his/her preparedness. Familiarity with the rules and practices of GCP, how trials are practically conducted, and risk assessment are also expected. The document goes into further details of how inspections should be done, documented and reviewed. Overall, the document strives to increase the transparency in GCP inspection process. These practices will be enforced by the EMA when finalized later this year. This is very similar to how FDA selects and trains its investigators. Actually, FDA wrote a document describing its expectations from its inspectors exactly 102 years ago to the day. The document holds true even today with most of the principles from 102 years ago intact. Upon reading the FDA document from more than a century ago, it comes as a surprise how much thought went into it before we all even knew what to expect. We hope the EC document is well received by the clinical research community and comes into force soon so we can have a harmonized GCP audit system in US and EU.
Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research