The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published a set of 16 frequently asked questions (FAQs) regarding Quality Risk Management (QRM). These questions and the respective answers give a good overview and indication on how EU Inspectorates will be inspecting and enforcing QRM elements with regard to the ICH guidelines Q8, Q9 and Q10. The later is currently implemented in chapter 1 of the EU GMP Guide, the contents of ICH Q9 have already been transferred to Annex 20 of the Guide.
It is clearly stated by the MHRA that in future all inspections will cover QRM processes as they are required by the EU GMP Guide Part1 Chapter 1 and Annex 20. Inspectors will have a look at ICH Q10 elements like
A company should therefore have procedures in place that embody quality risk management, including descriptions on how the management system operates. A risk register (or similar document) should list and track key risks. The respective processes should be reviewed by the management. In the FAQs also the key attributes are listed that should be observed.
For more details please also see the FAQs.
Compiled by Wolfgang SchmittOn behalf of the European Compliance Academy (ECA)