UK’s MHRA Enhances Risk-Based Inspection Process
This article was originally published in The Gold Sheet
Executive Summary
MHRA has begun sifting data with powerful software to help the British inspectorate set GMP inspection priorities – and even to alert companies to emerging issues so they can take steps to stay out of trouble. Other agencies show interest in using the system, which would enable data sharing that could make it even more sensitive and confident in its risk analysis.
You may also be interested in...
FDA’s New ‘Site Engagement’ Program Aims To Avert Quality-Related Drug Shortages
US FDA office that surveils drug manufacturing facilities invites sites on the cusp of failure for “engagements” in which they talk about how to turn things around. The agency says there’s no pressure – these site engagements aren’t enforcement actions and they’re completely voluntary.
Mutual Reliance Blossoming Among FDA, EMA, Other Inspectorates
FDA, EMA and other agencies are increasingly relying on each others' inspection results in an effort to spread their inspectional resources throughout the furthest corners of the globe. Inspection coordination remains somewhat ad hoc, with EMA keeping a spreadsheet for some and PIC/S enabling others. EMA's EudraGMP database is touted as a coordination hub.
The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration
Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.