This Technical Information Report (TIR) provides information on how to effectively implement FDA\u2019s regulation on Current Good Manufacturing Practices (CGMP) for combination products. Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and\/or biological products with one another, and the FDA regulation became effective July 22, 2013 (21 CFR Part 4). The TIR, where appropriate, also considers best practices, guide-lines, and standards used both in the United States and other regions. The overall goal of the TIR is to aid informed, risk-based decisions in establishing CGMP operating systems that support development, manufacture, premarket regulatory evaluation, and ultimately commercialization of combination products. It should be noted that, while the information contained in the TIR has been carefully considered, it is up to the individual manufacturer to ensure compliance with all regulatory requirements that apply to its products.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | AAMI TIR48:2015\/(R)2021, 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\u2019s CGMP Final Rule on Combination Products<\/b><\/p>\n |