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Ombination Roducts: I CGMP R

This document is a book about implementing cGMP requirements for combination products. It contains 8 chapters that cover topics such as quality system developments, risk management, human factors engineering, purchasing controls, cross labeled products, regulatory strategies, and a case study on developing a drug/autoinjector combination product. Each chapter provides information and guidance about the specific cGMP requirements as they relate to combination products and ensuring quality and safety. The book is intended as a reference for professionals working with combination products.

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129 views6 pages

Ombination Roducts: I CGMP R

This document is a book about implementing cGMP requirements for combination products. It contains 8 chapters that cover topics such as quality system developments, risk management, human factors engineering, purchasing controls, cross labeled products, regulatory strategies, and a case study on developing a drug/autoinjector combination product. Each chapter provides information and guidance about the specific cGMP requirements as they relate to combination products and ensuring quality and safety. The book is intended as a reference for professionals working with combination products.

Uploaded by

vijayns_250355172
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 6

COMBINATION

PRODUCTS
IMPLEMENTATION
OF cGMP

REQUIREMENTS

Lisa A. Hornback
Editor
www.pda.org/bookstore

CONTENTS

FOREWORD
Richard Levy

viii

INTRODUCTION
Lisa A. Hornback
References
About the Author

1
6
6

QUALITY SYSTEM DEVELOPMENTS TO MEET


COMBINATION PRODUCT REQUIREMENTS
Lisa A. Hornback
Introduction
21 CFR4 Applicability
Quality Systems Bridging the Gaps between Requirements
21 CFR 820 as Primary cGMP
21 CFR 211.84 Testing of Material

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iii

www.pda.org/bookstore

iv

Combination Products: Implementation of cGMP Requirements

21 CFR 211.103 Yield calculation


21 CFR 211.132 Tamper-evident packaging
21 CFR 211.137 Expiration dating
21 CFR 211.166 Stability testing
21 CFR 211.165 Testing/release for distribution
21 CFR 211.167 Special testing requirements
21 CFR 211.170 Reserve samples
21 CFR 211 as Primary cGMP
21 CFR 820.20 Management responsibility
21 CFR 820.30 Design controls
21 CFR 820.50 Purchasing controls
21 CFR 820.100 Corrective and preventive actions
21 CFR 820.170 Installation
21 CFR 820.200 Servicing
Risk Management in cGMP
Conclusion
References
About the Author

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RISK MANAGEMENT FOR COMBINATION PRODUCTS


Edwin Bills
Introduction
Complications for Combination Products
Risk Definition
Medical Devices
Pharmaceuticals and Biologics
Health Product Risk Management
The Risk Management Process
Hazard Identification
Hazardous Situation
Risk Estimation
Risk Control
Overall Residual Risk Evaluation
Risk Management Report
Production and Post-Production
Summary
References
About the Author

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www.pda.org/bookstore

Contents

DESIGN INPUTS AND ASSOCIATED DESIGN


VERIFICATION AND VALIDATION A PRIMER
ON APPLYING HUMAN FACTORS ENGINEERING
Author Israelski
Edwin
Introduction
HFE Process Details
System/Product Definition
Contextual Inquiry
Use Scenarios
Use Error Risk Analysis
Usability Objectives/Goals
Usability Objectives Planning
Customer Confirmation of Usability Objectives
Reporting of Usability Objectives
Iterative Design
Usability Evaluation and Testing
Formative testing
Summative testing
Post Implementation Analysis
Regulatory Body Expectations
The Future of HFR for Combination Products
References
About the Author

PURCHASING CONTROLS AND SUPPLIER


RELATIONSHIPS
Lisa Hornback
Introduction
Purchasing Control Process
Planning
Selection of Potential Suppliers
Supplier Evaluation and Control
Finalization of Controls
Delivery, Measurement and Monitoring
Feedback and Communication
Conclusion
References
About the Author

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vi

Combination Products: Implementation of cGMP Requirements

CROSS LABELED COMBINATION PRODUCTS


Suzanne OShea
Introduction
What are Cross Labeled Products?
Differences from General Use Devices
Marketing Applications
Mutually Conforming Labelling
Intent to Cross Label
Cross Labeling Challenges
Conclusion
References
About the Author

REGULATORY STRATEGIES FOR COMBINATION


PRODUCTS
William DAgostino
US FDA Regulatory Process
PMOA and Project Risks
Strategies for Development and Launch
Fast-Track Drug-Device Approval
PMOA Roadmap
European Union
EU products with device PMOA
EU products with drug PMOA
Combination Product Intellectual Property
Summary
References
About the Author

DEVELOPMENT OF A DRUG/AUTOINJECTOR
COMBINATION PRODUCT: A CASE STUDY
Mark A. Chipperfield, Ruby Gulati and Jennifer Mercer
Introduction
cGMP for Combination Products
Development of a Combination Product
Case Study Background
Development of the autoinjector
Quality systems
Risk management

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www.pda.org/bookstore

Contents

vii

Facility inspections
Human factors engineering
Outcome
Business process
Terminology Considerations
Quality system development
Development process
Unique testing requirements
Stability
Risk management
Quality plan
Conclusion
References
About the Authors

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APPENDIX
FEDERAL REGISTER: COMBINATION
PRODUCT FINAL RULE (WITH PREAMBLE)

171

INDEX

189

www.pda.org/bookstore

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