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15 September 2010

Free Access to WHO Inspection Reports

The World Health Organization (WHO) Prequalification of Medicines programme is specifically focusing on the implementation of GMP, assessment of GMP compliance and has a close link to the Quality Assurance (norms and standards) in the WHO.

The WHO issues Public Inspection Reports (WHOPIR), providing summaries of observations and findings made during inspections, mainly at sites in India and China. The reports are available at http://apps.who.int/prequal/WHOPIR/pq_whopir.htm.

Manufacturing sites are subject to periodic inspections and follow up inspections. The implementation of the corrective actions is verified by WHO by means of a documentation review or a follow-up inspection. Only when all critical or major non-compliances with WHO GMP, GCP or other equivalent guidelines have been satisfactorily corrected by the manufacturers or organizations, the sites are published on the list and the WHOPIR is issued. Although the manufacturing sites might have been inspected several times, only the WHOPIR of the last inspection, mentioned in the list, is available.

Warnings of non-compliance (called Notice of Concern, NOC) are published in this area: http://apps.who.int/prequal/assessment_inspect/info_inspection.htm#6. A NOC is a letter issued by the WHO Prequalification of Medicines Programme following an inspection at a site where observations resulted in concerns regarding compliance. It is published when the nature of deficiencies identified during an inspection at manufacturers of prequalified medicines and research organizations indicate a significant failure of the quality management system or non-compliance, resulting in inadequate assurance of product quality.

At the GMP Auditing Conference on 24 November 2010 in London, U.K., Anthony Gould, Manager at WHO, will introduce the WHO Prequalification of Medicines Programme. The GMP Auditing Conference is a full day Pre-Conference Session to the 5th QP Forum, being held on 25/26 November at the same venue. Please see “The QP Forum 2010” for more detailed information.

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