Direct Links to important GMP Inspection & Auditing Guidelines
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.
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.
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.
The purpose of this program is to direct the conduct of post-approval audits of NDA and ANDA establishments and to provide continuing coverage of approved products regardless of whether or not these products were covered under the pre-approval program.
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.
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
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).
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.