Drugmakers should use risk assessments to identify material attributes and manufacturing process parameters that may affect a drug’s critical quality attributes (CtQAs), an International Conference on Harmonisation (ICH) draft guidance states.

Risk assessments can be particularly useful in identifying CtQAs of complex drug products and can be used to rank the different quality characteristics according to their impact on the overall product. Understanding the mechanism of action and biological attributes — for example, through studies of structure-function relationships — can help to shed light on the risks of some products, the guidance states.

Manufacturers should identify potential CtQAs and define an appropriate manufacturing process and control strategy, according to the draft, released for public comment in 2011.

Clinical trial sponsors rely on clinical quality assurance auditors to find vulnerabilities before noncompliance can shut down their studies.

But with millions of dollars and decades of research at stake, study staffers aren’t always eager to cooperate.

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