The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2019 to March 2020.
Someday these reports won’t take a year to write. If I took a year writing my annual reports I would receive an inspection finding from the MHRA.
There is no surprise that the five critical observations are all from risk management. Risk management is also the largest source of major findings, with quality management a close second with a lot of growth.
There are a lot of observations around the smooth and effective running of the CAPA program; a fair amount on PSMF management; and a handful on procedure, training and oversight.
Looking at the nine major observations due to deficiencies in the management of CAPA, the MHRA reports these problems:
- Delays to CAPA development
- CAPA that did not address the root cause and impact analysis for the identified noncompliance
- Open CAPA which were significantly past their due date
- CAPA raised from a previous critical finding raised at an earlier MHRA inspection had not been addressed
I’m going to go out on a limb here and say some of these stem from companies thinking non-GMP CAPAs do not require the same level of control and scrutiny. Root Cause Analysis and a good CAPA program are fundamental, no matter where you fall on (or out of) the pharmaceutical regulatory spectrum.