Direct Links to important GMP Inspection & Auditing Guidelines

Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

This guidance document is intended for medical device manufacturers and it is expected that the reader is familiar with regulatory quality management system requirements within the medical devices sector. This guidance document may also be useful to regulatory authorities and suppliers. This guidance document is intended for educational purposes and it is not intended to be used to assess or audit compliance with regulatory requirements.

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Guidelines for Regulatory Auditing of Quality Management Systems of Medical DeviceManufacturers Part 3: Regulatory Audit Report

This document gives guidance to regulators, auditing organizations and auditors on the content of audit reports. However, it may also help the auditee understand and respond to the audit findings.

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Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 4: Multiple Site Auditing

This document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device manufacturers with multiple sites. This document should be read in conjunction with the Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers -- Part 2: Regulatory Auditing Strategy (GHTF/SG4/N30).

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Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 5: Audits of manufacturer control of suppliers

This document gives guidance for the auditing of a manufacturer’s purchasing controls, including the audit of the suppliers when suppliers should be audited and what a supplier audit should cover, adding to the guidance given in GHTF/SG4/N28 and GHTF/SG4/N30.

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Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers Supplement No. 3: Training Requirements for Auditors:2000

The document describes in more detail training elements required to:i prepare an individual to be an auditor; ii qualify auditors to conduct regulatory audits of medical device manufacturers’ quality systems; and iii maintain their qualifications.

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Auditing Guide - Annex 1 – Pre-Audit Questionnaire

The purpose of this questionnaire is to facilitate the preparation of the auditors for the audit at the API manufacturer's site.

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Auditing Guide - Annex 2 – Aide Mémoire

The purpose of the Aide Memoire is to support the auditors with leading questions in conducting the audit.

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Auditing Guide - Annex 3 – Audit Report Template

This template provides a standard for reports fo audits conducted within the framework of the APIC Audit Program.

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Quality Management System - Medical Devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange

This document provides a method to present outcomes of regulatory audits that can be used by regulatory authorities for information exchange. It introduces a nonconformity grading system for regulatory purposes with a Regulatory Audit Information Exchange Form providing standardized results.

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Regulatory Authority Assessor Competency and Training Requirements

This document applies to Regulatory Authorities conducting assessments of AOs. Adherence to this document and its requirements will help mitigate the risk of inconsistent or ineffective assessments of AOs by ensuring that Regulatory Authority personnel have the necessary commitment, competency, experience, and training before conducting an assessment or participating in a decision to recognize an Auditing Organization.

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GMP Conferences by Topics

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