After two years of receiving input from industry regarding EU quality risk management regulations and practices, U.K.’s MHRA has just posted a list of 16 Frequently Asked Questions about QRM that industry should mull over. Among them:

Is it acceptable to link QRM with cost-saving measures? (Hmm,  a trick question if I ever saw one!)

What tools are acceptable in Quality Risk Management? (Hint: The answer is short and simple.)

Should we expect there to be no risk to patient safety as a conclusion to a risk assessment? (Is “no risk” ever in the pharma vocabulary?)

Some of the FAQ’s apply directly to EU GMPs, but most are relevant to anyone involved in drug Quality.

I’ll end this post with MHRA’s question #8: What are the key attributes of a good risk assessment?

The following key attributes should be observed (mindful of the risk significance addressed in the previous question):

• clearly identify the process being assessed and what it is attempting to achieve, ie what the harm/risk is and what the impact could be on the patient
• be based on systematic identification of possible risk factors
• take full account of current scientific knowledge
• be conducted by people with experience in the risk assessment process and the process being risk assessed
• use factual evidence supported by expert assessment to reach conclusions
• do not include any unjustified assumptions
• identify all reasonably expected risks – simply and clearly along with a factual assessment and mitigation where required
• be documented to an appropriate level and controlled/approved
• ultimately be linked to the protection of the patient
• should contain objective risk mitigation plans.

Kudos to Madhu Raju Sahee of the Global Pharma Dialogue blog for calling our attention to these FAQs.

–Paul Thomas

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