Direkt Links to important GMP Inspection & Auditing Guidelines

Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations

This document defines the content of the Regulatory Assessment Program. The Assessment Program defines how Regulatory Authorities will recognize, monitor, and re-recognize Auditing Organization under the framework of the IMDRF MDSAP.

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Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7)

This document has been written to provide assistance in the application of the 'Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General requirements’ and should be read in conjunction with that document.

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Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers –Part 1: General Requirements

This document provides guidelines for auditing organisations responsible for establishing, planning, carrying out and documenting audits of quality systems to address regulatory requirements for manufacturers of medical devices.

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Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies

This document has been written to provide assistance in the application of the 'Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General requirements’ and should be read in conjunction with that document.

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APIC CEFIC Auditing Guide

This document aims to set standards for audits in API production sites and to provide guidance for the implementation and maintenance of an effective audit system.

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The APIC Audit Programme

The APIC Audit Programme describes a standardised Third Party Auditing process.

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Audit Language Requirements (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 1)

The document provides requirements on audit language

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Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy

This document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device manufacturers based on the process approach to quality management system requirements (e.g., ISO 13485:2003 and 21 CFR Part 820).

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FDA COMPLIANCE POLICY GUIDE Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02)

Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.

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Annex 1 - Contract between Auditor and the API Compliance Institute

Contract between Auditor and the API Compliance Institute.

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GMP Conferences by Topics

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