GHTF recently posted this proposed guidance document at www.ghtf.org. The document, a member of the series on auditing, covers audits of a device manufacturer’s system to control suppliers.
The Global Harmonization Task Force (GHTF) is an international organization that encourages regulatory practice convergence to ensure the safety, effectiveness / performance, and quality of medical devices; promoting technological innovation; and facilitating international trade. GHTF publishes and disseminates harmonized documents on basic regulatory practices.
Study Group 4 (SG4) covers work in the area of Quality Auditing. This new draft (Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 5: Audits of manufacturer control of suppliers) joins a series of auditing guidance documents already issued:
SG4/N28R4:2008 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 1: General Requirements
GHTF-SG4-(00)3 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 1: General Requirements – Supplement 2: Training Requirements for Auditors
SG4/N30R20:2006 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy
SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports
The proposed guidance also refers to:
SG1/N055:2009: Definitions of the Terms Manufacturer, Authorized Representative, Distributor, and Importer
SG3/N17:2008 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers