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AAMI TIR48 2024

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AAMI TIR48:2024 – Quality Management System (QMS) guidance on compliance with FDA’s Final Rule on combination products

Published By	Publication Date	Number of Pages
AAMI	2024	47

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


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Standard Title	AAMI TIR48:2024 – Quality Management System (QMS) guidance on compliance with FDA's Final Rule on combination products
Published Code	AAMI
Publication Date	2024
Pages Count	47

AAMI TIR48 2024

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