AAMI TIR48 2015 R2021
$44.96
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
| Published By | Publication Date | Number of Pages |
| AAMI | 2015 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR48:2015/(R)2021 [HISTORICAL], Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products |
| 2 | Copyright information |
| 3 | Title page |
| 4 | AAMI TECHNICAL INFORMATION REPORT |
| 5 | Contents Glossary of Equivalent Standards |
| 6 | Committee Representation |
| 7 | Introduction |
| 9 | 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Applying CGMPs in accordance with the FDA’s Final Rule for Combination Products (21 CFR Part 4) 2.1 Combination product definitions and examples |
| 10 | 2.2 CGMP requirements |
| 11 | Figure 1 – Applying CGMPs in Accord with FDA’s Final Rule for Combination Products |
| 12 | 3 Considerations in transitioning to ‘Streamlined Approach’ 3.1 Overview of considerations 3.2 Transition from device to combination product 3.3 Transition from drug or biologic to combination product |
| 13 | Table 3.2 – Considerations under 21 CFR Part 211 for products operating underan 820 quality system transitioning to the Streamlined Approach |
| 15 | Table 3.3 –Considerations under 21 CFR Part 820 |
| 16 | 4 Application of design controls and risk management for acombination product 4.1 Overview 4.2 Initiating and planning design controls |
| 18 | Figure 2 – Example of aligned vs. unaligned combination product developmentprocesses |
| 19 | 4.3 Risk management considerations for combination products 4.4 Exemplary combination product risk management process steps |
| 20 | Table 4.5.1 – Examples of Quality Attributes that, if notmet, may result in a Hazard |
| 21 | 4.5 Drug/biologic (ICH Q9) and device (ISO 14971) focused risk assessment |
| 22 | Table 4.5.2 – Examples of characteristics that, if not met, may result in a hazard |
| 23 | Annex A: Terminology |
| 27 | Bibliography |
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