Tuesday 2 July 2013

WHO Guideline on Quality Risk Management

According to the ECA, Annex 2 of the new Technical Report 981, a new WHO guideline on the implementation of a quality risk management system, has been issued. The aim of this guideline is to assist the implementation of a QRM system, covering activities such as development, manufacturing, sourcing of materials, testing, packaging and storage.

According to the Annex:

"The aim of these guidelines is to assist the development and  implementation of effective QRM, covering activities such as research and  development, sourcing of materials, manufacturing, packaging, testing, storage  and distribution. In the past, hazard analysis and critical control point (HACCP)  methodology, traditionally a food safety management system but subsequently  applied to other industries, has been the basis of WHO risk management guidance  to the pharmaceutical industry."

For further details, see the WHO.

Posted by Tim Sandle

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