| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | AAMI TIR48:2015\/(R)2021 [HISTORICAL], Quality Management System (QMS) Recommendations on the Application of the U.S. FDA\u2019s CGMP Final Rule on Combination Products <\/td>\n<\/tr>\n | ||||||
| 2<\/td>\n | Copyright information <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI TECHNICAL INFORMATION REPORT <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents Glossary of Equivalent Standards <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Committee Representation <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Applying CGMPs in accordance with the FDA\u2019s Final Rule for Combination Products (21 CFR Part 4) 2.1 Combination product definitions and examples <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 2.2 CGMP requirements <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Figure 1 – Applying CGMPs in Accord with FDA\u2019s Final Rule for Combination Products <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | Table 3.2 \u2013 Considerations under 21 CFR Part 211 for products operating underan 820 quality system transitioning to the Streamlined Approach <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | Table 3.3 \u2013Considerations under 21 CFR Part 820 <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4 Application of design controls and risk management for acombination product 4.1 Overview 4.2 Initiating and planning design controls <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | Figure 2 \u2013 Example of aligned vs. unaligned combination product developmentprocesses <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4.3 Risk management considerations for combination products 4.4 Exemplary combination product risk management process steps <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Table 4.5.1 \u2013 Examples of Quality Attributes that, if notmet, may result in a Hazard <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 4.5 Drug\/biologic (ICH Q9) and device (ISO 14971) focused risk assessment <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Table 4.5.2 \u2013 Examples of characteristics that, if not met, may result in a hazard <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Annex A: Terminology <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR48:2015\/(R)2021 – Quality Management System (QMS) Recommendations on the Application of the U.S. FDA\u2014s CGMP Final Rule on Combination Products<\/b><\/p>\n |