The WHO Prequalification of Medicines programme is specifically focusing on the implementation of GMP, assessment of GMP compliance and has a close link with the Quality Assurance (norms and standards) in WHO.
The web page of the programme also comprises World Health Organization Public Inspection Reports (WHOPIR). A WHOPIR reflects the inspection report and gives a summary of the observations and findings made during the inspection, mainly at sites in India and China.
Manufacturing sites are subjected 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 are 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 also published in this area. An NOC is a letter issued by the WHO Prequalification of Medicines Programme, after an inspection was performed at a site where observations were made that result in concern regarding compliance of the site. 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.
On behalf of the European Compliance Academy (ECA)