The World Health Organisation (WHO) have updated their guidance on quality system requirements for national good manufacturing practice (GMP) inspectorates. The aim of the update is to align with international standards and the latest quality management system (QMS) principles.
The draft guidance document, which is open for comment, discusses what a QMS is, what it should do for an inspectorate and how it aims to help senior managers achieve their targets and quality objectives.
In the section regarding documentation, WHO outlines 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.”
Also outlined in the document are the aspects of what a document control system should ensure. Regarding inspections, WHO states how they should be planned in advance and risk management principles should be established for prioritising inspections.
The guidance states that “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 organisation”.
WHO is seeking comments on the draft guidance until the end of September, and the document will be presented at the 54th meeting of its Expert Committee on Specifications for Pharmaceutical Preparations in October 2019.
To read WHO’s draft guidance on quality management system requirements for national inspectorates, please click here.