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AAMI TIR48:2015/(R)2021 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products >
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AAMI TIR48:2015/(R)2021 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products, 2021
- AAMI TIR48:2015/(R)2021, Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
- Copyright information
- Title page
- AAMI TECHNICAL INFORMATION REPORT
- Contents
- Glossary of Equivalent Standards
- Committee Representation
- Introduction
- 1 Scope [Go to Page]
- 2 Applying CGMPs in accordance with the FDA’s Final Rule for Combination Products (21 CFR Part 4) [Go to Page]
- 3 Considerations in transitioning to 'Streamlined Approach' [Go to Page]
- 4 Application of design controls and risk management for acombination product [Go to Page]
- Annex A: Terminology
- Bibliography [Go to Page]
