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eLibrary > AAMI TIR48:2024 - Quality Management System (QMS) guidance on compliance with FDA\'s Final Rule on combination products >

AAMI TIR48:2024 - Quality Management System (QMS) guidance on compliance with FDA\'s Final Rule on combination products, 2024

AAMI TIR48:2024; Quality management systems (QMS) recommendations on application of the U.S. FDA’s CGMP final rule on combination products
Title page
AAMI Technical Information Report
Copyright information
Contents
Committee representation
Foreword
Introduction
1 Scope [Go to Page]
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.) [Go to Page]
4.1 Combination product definitions and examples
4.2 CGMP requirements [Go to Page]
Figure 1—Applying CGMPs in accord with the FDA’s final rule on combination products
5 Considerations in adopting a 'Streamlined Approach' [Go to Page]
5.1 Overview of considerations
5.2 Transition from device to combination product [Go to Page]
Table 1—Considerations under 21 CFR Part 211 for products operating under a 21 CFR Part 820 quality system transitioning to the streamlined approach
5.3 Transition from drug or biologic to combination product [Go to Page]
Table 2 — Considerations under 21 CFR Part 820
5.4 Alternative or streamlined mechanisms for complying with the CGMPs for combination products [Go to Page]
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 [Go to Page]
6.1 Overview
7 Application of design controls and risk management for a combination product [Go to Page]
7.1 Overview
7.2 Initiating and planning design controls [Go to Page]
Figure 2—Example of aligned vs. unaligned combination product development processes
Figure 3—Interdependence of drug, device, and combination product development with risk management
7.3 Risk management considerations for combination products
7.4 Drug/biologic (ICH Q9(R1)) and device (ISO 14971:2019) focused risk assessment [Go to Page]
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
8 Application of purchasing controls for a combination product [Go to Page]
8.1 Overview
9 Corrective and preventive action (CAPA) [Go to Page]
9.1 Overview
10 Inspection readiness
10.1 Overview
10.2 Scope of CGMP requirements for a facility
10.3 Personnel preparedness
10.4 Risk management considerations
Annex A (informative) Terminology
Bibliography [Go to Page]

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