Quality Risk Management (QRM

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Quality Risk Management

How to effectively implement a QRM!


Quality Risk Management (QRM) should be focussed on the quality of the product – level of detail commensurate with the task in hand. Systematic approach for assessment, control, communication and review of the risks to the quality of the medicinal product.

Managing Risks

Often issues with teams working to the same objectives, however poor communication can lead to issues.

Preventable Risks – activities that can be carried out upon identifying a potential risk:

Training – Staff usually make mistakes/errors due to lack of knowledge, training can prevent risks of deviations and can maintain a more controlled work flow.

Strategy Risks – combination of decision makers and Questioners in control of critical thinking of risks involved with your organisations activities

External Risks – This includes internal risk-management functions and leadership teams;

At times risks are uncontrollable for example staff shortages/leaving, extreme weather conditions, acquisitions, cyber attacks etc.

In cases of Marketing Authorisation holders, that have been acquired, there are sometimes then gaps because the company has not remained abreast of the updated regulations.

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