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AAMI TIR48:2024 - Quality Management System (QMS) guidance on compliance with FDA\'s Final Rule on combination products, 2024
- AAMI TIR48:2024; Quality management systems (QMS) recommendations on application of the U.S. FDA’s CGMP final rule on combination products
- Title page
- AAMI Technical Information Report
- Copyright information
- Contents
- Committee representation
- Foreword
- Introduction
- 1 Scope [Go to Page]
- 2 Normative references
- 3 Terms and definitions
- 4 Applying CGMPs in accordance with the FDA’s final rule on combination products (21 CFR Part 4.A.) [Go to Page]
- 5 Considerations in adopting a 'Streamlined Approach' [Go to Page]
- 6 Application of management responsibility for a combination product manufacturer [Go to Page]
- 7 Application of design controls and risk management for a combination product [Go to Page]
- 8 Application of purchasing controls for a combination product [Go to Page]
- 9 Corrective and preventive action (CAPA) [Go to Page]
- 10 Inspection readiness
- 10.1 Overview
- 10.2 Scope of CGMP requirements for a facility
- 10.3 Personnel preparedness
- 10.4 Risk management considerations
- Annex A (informative) Terminology
- Bibliography [Go to Page]
