13/14 March 2024
Annex 2 of the new Technical Report 981 is a new WHO guideline on the implementation of a quality risk management system. 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. The document has its origin already in 2010 but due to the numerous comments it was revised again and again and finally completely new structured in 2011 as we already have reported.
The guideline is directed to the pharmaceutical manufacturers (as integral part of the quality assurance system) as well as to the regulatory authorities (e.g. in the case of a risk-based inspection planning). One chapter addresses the tools that may possibly be applied. Apart from the more frequently used tools such as FMEA, HACCP and HAZOP, tools such as fault-tree analysis, process-mapping and flowcharts also are mentioned. The matrix tables on impact/consequence as well as the exemplary specification of numbers that show how the probability of occurrence - reaching from rare, unlikely ... to likely, almost certain - can be translated in numbers are interesting. Here, reference is made to a document by the Product Quality Research Institutes (PQRI).
For further information please see the "WHO Guidelines on Quality Risk Management".