Direct Links to important GMP Inspection & Auditing Guidelines

Regulatory Assessment Program and Assessment Strategy Utilizing for the Recognition and Monitoring of Medical Device Auditing Organizations

The present document explains the typical content and strategy applied of each assessment step in the Regulatory Assessment Program described below for the recognition and monitoring of Auditing Organization that will perform medical device regulatory audits.

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Guidance for Industry: Cosmetic Good Manufacturing Practices

This new draft Guideline includes recommendations on documentation, recordkeeping, buildings and facilities, equipment, raw materials, production, internal audits, laboratory controls, handling of complaints and reports of adverse events as well as on conducting recalls.

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COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices

The Recommendation aims at ensuring that the notified body carries out a proper verification of the fulfilment of the legal requirements by the manufacturer.

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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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Guidance for Regulatory Authority Assessors on the Method of Assessment for MD SAP Auditing Organizations

This document provides guidance on the process-based assessment method described in section 6 of the document IMDRF/MDSAP WG/N5. The assessment method specific to a particular medical device regulatory audit scheme may take into account additional requirements from the jurisdictions addressed in the scheme.

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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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GMP Conferences by Topics

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