Quality Risk Management


Integrating Quality Risk Management into Your Quality System

ICH Q9 Quality Risk Management is now incorporated as Annex 20 into European GMPs. As a result, the MHRA are now asking companies, to integrate quality risk management into their quality systems. The MHRA are the first EU regulator to embrace and implement a risk based inspection programme. This follows extensive consultation with the industry and other stakeholders.  The risk based inspection programme, involves companies being allocated a risk rating, following an inspection and on additional relevant intelligence about the company’s compliance posture, which will impact on the frequency of inspection in the future.

We have experience in integrating quality risk management into quality systems so that the company gains from the benefits of both a quality risk management plan and complies with Annex 20.

 We can also provide risk assessment training using FMECA, root cause analysis training and SOP writing, to help you to comply with annex 20 quickly.

 For further information, please contact us at info@paulgraham-consulting.com

Integrating Quality Risk Management into a Quality System

Integrating Quality Risk Management into a Quality System