WHO Guideline on QRM Taking Shape

The World Health Organization (WHO) asked specific stakeholders in August to comment on a working draft of a detailed guideline it is preparing on the expectations for quality risk management (QRM) in pharmaceutical manufacturing.  The guideline will update WHO’s advice to industry and regulatory bodies in the risk assessment area and align it with more recent documents published by other international regulatory authorities.

The WHO draft draws heavily from ICH’s Q9 guideline and the Product Quality Research Institute (PQRI) 2008 report “Quality Risk Management Principles and Industry Case Studies,” including borrowing tables for inclusion in its document.

In line with a newly-issued FAQ from UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on inspecting QRM (IPQ “In the News” September 23), WHO maintains in the draft that drug manufacturers should have a “risk register” and a defined document management control system including periodic reviews of risk management assessments.  The “risk register” paragraph in the WHO draft is taken verbatim from the MHRA FAQ document.

WHO will accept comments on the 24-page working draft from designated stakeholders until October 1.  The draft document and comments received are scheduled to be discussed in late October in Geneva, Switzerland at the meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations.

[More on the WHO draft and its detailed guidance to both regulators and industry on QRM and a link to referenced documents is provided for subscribers here.  For subscription information click here.]