Wednesday 10 June 2020

WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-fourth report

The World Health Organisation has published ‘WHO Expert Committee on Specifications for Pharmaceutical Preparations: fifty-fourth report’.

The WHO Technical Report Series makes available the findings of various international groups of experts that provide WHO with the latest scientific and technical advice on a broad range of medical and public health subjects. Members of such expert groups serve without remuneration in their personal capacities rather than as representatives of governments or other bodies; their views do not necessarily reflect the decisions or the stated policy of WHO.

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There is a new Annex 3 – ‘Production of water for injection by means other than distillation’.

An important section for microbiologists reads:

“The system should be monitored for its ongoing performance within defined parameters, including but not limited to, conductivity, total organic carbon (TOC) and microbial contamination.

A combination of online and offline monitoring of WFI should be done, to ensure that the appropriate water specification is maintained. TOC and conductivity should be monitored with online instruments. Use of rapid microbiological methods is encouraged for timely monitoring, and aids with rapid responses to prevent deterioration of the system.”

The report can be found here:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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