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.

“The inspection report should be sent to the inspected company or organization within the inspectorate’s established timelines. The lead inspector and all concerned inspectors and/or experts should participate in assessing the company’s response to determine the appropriateness of corrective and preventive actions as well as the GXP compliance status of the company or organization,” the guidance says.

The document also features a section on operational planning and performance evaluation.

WHO said it’s seeking comments through the end of September on the working document, and the document will be presented at the 54^th meeting of its Expert Committee on Specifications for Pharmaceutical Preparations in October.

Source: Regulatory Affairs Professionals Society