This Technical Information Report (TIR) provides information on how to effectively implement FDA’s 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.

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

Published By	Publication Date	Number of Pages
AAMI	2021


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Standard Title	AAMI TIR48:2015/(R)2021 Quality Management System (QMS) Recommendations on the Application of the U.S. FDA’s CGMP Final Rule on Combination Products
Published Code	AAMI
Publication Date	2021

AAMI TIR48 2015 RA2021

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