Direct Links to important GMP Inspection & Auditing Guidelines

Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

This is one document in a collection of documents produced by the International Medical Device Regulators Forum (IMDRF) intended to implement the concept of a Medical Device Single Audit Program (MDSAP). This document applies to Auditing Organizations that audit medical device manufacturers and may perform other related functions.

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Competence and Training Requirements for Auditing Organizations

This document applies to recognized Auditing Organizations conducting audits of a medical device manufacturer for regulatory purposes. Adherence to this document and its requirements will help mitigate the risk of inconsistent or ineffective assessments of manufacturers by ensuring that Auditing Organization personnel have the necessary commitment, competence, experience, and training before conducting an audit or undertaking a decision making function.

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MD SAP Assessment and Decision Process for the Recognition of an Auditing Organization

This document defines: - The process and lifecycle for recognizing, maintaining, or ceasing recognition of an Auditing Organization. - The process of managing, grading, and closure of assessment nonconformities issued to an Auditing Organization; and, - The outcomes of an initial, surveillance, or re-recognition assessment process of an Auditing Organization.

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Medical Device Regulatory Audit Reports

The scope of this guidance document is limited to the information that participating MDSAP Regulatory Authorities require in medical device regulatory audit reports, the format of reports and the information necessary for participating MDSAP Regulatory Authorities to effectively use the audit reports in accordance with their legislation.

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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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Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

In the past, various Regulatory Authorities have identified shortcomings in the standards being utilized for the recognition of organizations that conduct medical device audits for regulatory purposes. These standards were considered to be too generic and focused on commercial entities for commercial purposes. However, many organizations that work in the regulated environment of medical devices must comply with these generic requirements for other purposes.

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Registered Starting Material Auditing Guide - Annex 1 - Aide Mémoire

This documents can be used as a checklist during audits at starting materials manufacturers.

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