AAMI TIR48 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS
Hardcopy , PDF
05-21-2021
English
01-01-2015
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Glossary of equivalent standards
Committee representation
Introduction
1 Scope
2 Applying CGMPs in Accord with FDA's Final Rule
for Combination Products (21 CFR Part 4)
3 Considerations in transitioning
to 'Streamlined Approach'
4 Application of Design Controls and
Management for a Combination Product
Annex A - Terminology
Bibliography
Gives recommendations on the application of CGMPs for drugs, devices, biologics, and human cells, tissues, and cellular and tissue based products during development and marketing of combination products (drug-device, biologic-device, drug-biologic, or drug-device-biologic), in accordance with the FDA's final rule (21 CFR Part 4; 78 FR 4307, 2013-hereafter 'The Rule' or 'FDA's Final Rule').
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| ISO 19011:2011 | Guidelines for auditing management systems |
| CFR 21(PTS200-299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299 |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| ISO 9004:2009 | Managing for the sustained success of an organization A quality management approach |
| ISO 9001:2015 | Quality management systems — Requirements |
| CFR 21(PTS600-799) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 600-799 |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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