As of May 2017, MHRA Deficiencies has been established.
Originally conceived in 2016, MHRA deficiencies aims to make EU inspection findings visible to industry and allow for meaningful trending. MHRA Deficiencies aims to bring approx 4000 inspection deficiencies into an easily searchable, readily accessible database for access on a subscription basis.
Currently, EU inspection deficiencies are not released to the public or industry. this is troubling for the following reasons:
- The industry lacks detail on problems and/or emerging trends
- The industry is largely reactive and slow to adapt to new expectations or requirements
- There is a lack of transparency in the GMP/GDP inspection world
MHRA Deficiencies firmly believes that making pharmaceutical inspection findings visible and publically available will ultimately help the industry. There will be increased opportunities to learn from the mistakes and problems of others and implement meaningful, data driven inspection readiness and quality & compliance improvements.
Established by Ian Ramsay, himself an ex-MHRA GMDP inspector, MHRA Deficiencies will be available for public access shortly. Please check back reguarly.
Ian Ramsay currently operates as an independent quality consultant serving the GMP and GDP world. Further information can be found here: