| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | AAMI TIR48:2024; Quality management systems (QMS) recommendations on application of the U.S. FDA\u2019s CGMP final rule on combination products \n <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Technical Information Report Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references 3 Terms and definitions 4 Applying CGMPs in accordance with the FDA\u2019s final rule on combination products (21 CFR Part 4.A.) 4.1 Combination product definitions and examples <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 4.2 CGMP requirements <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | Figure 1\u2014Applying CGMPs in accord with the FDA\u2019s final rule on combination products <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 5 Considerations in adopting a ‘Streamlined Approach’ 5.1 Overview of considerations 5.2 Transition from device to combination product Table 1\u2014Considerations under 21 CFR Part 211 for products operating under a 21 CFR Part 820 quality system transitioning to the streamlined approach <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.3 Transition from drug or biologic to combination product <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | Table 2 \u2014 Considerations under 21 CFR Part 820 <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.4 Alternative or streamlined mechanisms for complying with the CGMPs for combination products <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Table 3\u2014Examples of alternative or streamlined mechanisms for demonstrating CGMP compliance for combination products 6 Application of management responsibility for a combination product manufacturer 6.1 Overview <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 7 Application of design controls and risk management for a combination product 7.1 Overview <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 7.2 Initiating and planning design controls <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Figure 2\u2014Example of aligned vs. unaligned combination product development processes <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Figure 3\u2014Interdependence of drug, device, and combination product development with risk management <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 7.3 Risk management considerations for combination products 7.4 Drug\/biologic (ICH Q9(R1)) and device (ISO 14971:2019) focused risk assessment <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | Table 4\u2014Examples of quality attributes that, if not met, may result in a hazard Table 5\u2014Examples of characteristics that, if not met, may result in a hazard <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 8 Application of purchasing controls for a combination product 8.1 Overview <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 9 Corrective and preventive action (CAPA) 9.1 Overview <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 10 Inspection readiness 10.1 Overview <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 10.2 Scope of CGMP requirements for a facility 10.3 Personnel preparedness <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 10.4 Risk management considerations <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | Annex A (informative) Terminology <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR48:2024 – Quality Management System (QMS) guidance on compliance with FDA’s Final Rule on combination products<\/b><\/p>\n |