For 19 years ICH GCP E6 has not changed. Now, nearly two decades after its initial release, change is coming. Perhaps the biggest difference is the focus and preeminence of Quality Management.
A modernized quality standard for clinical study processes is being espoused which is driving the adoption of Quality-by-Design and Quality Risk Management principles and methodologies by their full embrace throughout the guideline. Quality Management is expected to be risk-based, being applied to both the monitoring and auditing aspects of the clinical study process.
Going hand-in-hand with Quality Management is compliance. The draft addendum expands upon what is already written, by further stating that when there is significant non-compliance, it is the sponsors responsibility to perform a root cause analysis, implement corrective and preventive measures, and when needed, inform regulators. This facet of the Quality Management preeminence boosts the already existing quality-by-design and adaptive risk-based approach, with continuous improvement of the Quality Management processes themselves.
The changes being made to ICH GCP E6 (R1) reflect what is happening in the industry and are areas that have been highlighted by inspectors for several years. Some of these changes reflect guidance documents issued by regulatory authorities. These changes are expected to go into effect by November 2016. So mark your calendars.
For a consolidated list of the changes you can visit my blog, Ethics Nut, and scroll down to the post “Just the Additions – Consolidated Changes to ICH GCP E6 (R2).
For the full ICH GCP E6 (R2) you can access it here.