The World Health Organization (WHO) has revised its guidance on quality system requirements for national good manufacturing practice (GMP) inspectorates to align with international standards and the latest quality management system (QMS) principles and to expand the document’s scope.
The guidance outlines what a QMS is, what it should do for an inspectorate and how it should help senior management better achieve their targets and quality objectives. “Senior management’s commitment and active participation is essential to ensure implementation of the QMS and to support of staff within the inspectorate,” the document says.
WHO also discusses management, management system planning, resources, personnel, infrastructure and documentation.
In the section on documentation, WHO discusses how the inspectorate “should have procedures on handling quality, safety and efficacy issues which may lead to recall or the withdrawal of products from the market. Where applicable, the inspectorate should establish and maintain a system for communicating Rapid Alerts. Records of recalls and withdrawals should be maintained in accordance with national legislation.”
The document also outlines aspects of what a document control system should ensure. As far as the inspections, WHO explains how they should be planned in advance and risk management principles should be established for prioritizing inspections…