Validation for Medical Device and Diagnostic Manufacturers, Second Edition

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ISBN: 9781574910636 | 1574910639
Cover: Hardcover
Copyright: 9/30/1997

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Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.

Introduction

xiii

Introduction to Quality Systems

(6)

Quality Control, Quality Assurance, and Quality Systems

(1)

Quality System Summary

(1)

Quality System Requirements in Five Steps

(1)

The Commitment to Validate

(1)

Bibliography

(2)

Validation Overview

(14)

Regulations, Guidelines, and Expectations for Validation Studies

(2)

When Are Validation Studies Required? When Are Validation Studies Appropriate?

(1)

When Are Validation Studies Performed in the Product Life Cycle?

(1)

Design, Process, and Method Validation Relationships

(1)

Who Designs and Performs Validation Studies?

(1)

When Clinical Use Product Is Produced in the Development Laboratory

(1)

Specification Testing

(1)

Validation Studies Versus Qualification Studies

(1)

Validation Study Strategies

(1)

Fundamental Elements of Validation

(1)

Validation Terminology and Definitions

(1)

Prospective and Retrospective Validation Studies

(2)

Revalidation

(1)

Summary

(1)

A Look Ahead

(1)

References

(1)

Bibliography

(2)

Product Development and Validation

(20)

Design Input: Defining the Product Design Endpoint

(2)

Designing and Design Analysis

(1)

Design Output: Documenting the Design

(1)

Design Verification: Demonstrating That the Design Endpoint Is Achievable

(2)

Design Validation: Demonstrating That User Requirements Are Satisfied

(3)

Medical Device Software Validation

(1)

Ensure That Design Verification and Validation Studies Are Meaningful

(1)

Design Validation and Design Transfer

(1)

The Evolution of Validation for Medical Product Manufacturers

(2)

References

(2)

Appendix 3.A. Content Considerations for a Design Verification Study Plan and Protocol

(1)

Appendix 3.B. Content Considerations for a Design Validation Study Plan and Protocol

(2)

Appendix 3.C. Design Transfer Decision Record

(2)

Validation Study Plans, Protocols, Reports

(8)

Validation Study Master Plans

(1)

Validation Study Plans or Protocols

(2)

Validation Study Reports

(1)

Validation Study Notebooks/Validation Study Files

(1)

Validation Study Disposition Records

(1)

References

(1)

Appendix 4.A. Format and Content Considerations for a Validation Study Master Plan

(3)

Process Development and Validation

(18)

Process Development

(5)

Process Validation Studies

(1)

Process Validation Candidates

(1)

Validation Studies Can Minimize Process Specification Testing

(1)

Are Validation Studies the Only Option?

(1)

Who Performs Validation Studies and When?

(1)

Process Validation or Qualification Study Protocols: Format and Content Considerations

(3)

Equipment-Dependent Processes

(1)

Process Failures and Out-of-Specification Results

(1)

Revalidation

(1)

Summary

(1)

Bibliography

(1)

Appendix 5.A. Sample Process Validation Study Protocol

(3)

Test Method Development and Validation

(18)

Test/Inspection Method Validation: Regulatory Requirement or NOT?

(1)

The Life Cycle of a Test/Inspection Method

(1)

Method Development

(4)

Method Control: Is Validation the Only Option?

(2)

Who Performs the Study?

(1)

Method Qualification or Validation

(1)

Study Protocol Format and Content: Test/Inspection Methods

(2)

Routine Monitoring of a Validated Test/Inspection Method

(1)

Method Failures Versus Out-of-Specification Results

(1)

Training of Technicians

(1)

In Vitro Diagnostics: When the Test Method Is the Product

(1)

Summary

(1)

References

(1)

Bibliography

(2)

Qualification of Equipment and Equipment Systems

(24)

What About Equipment Validation?

(1)

What Equipment Requires a Qualification Study?

(1)

Equipment Qualification Study Protocol: Format and Content

(3)

Equipment and Equipment System Development During Start-Up

(1)

Use of Contract ``Validation'' Services

(1)

New or Existing?

(1)

Equipment Versus Equipment Systems

(1)

The Commitments of Routine Maintenance, Calibration, and Change Control

(1)

Bibliography

(2)

Appendix 7.A. Sample Installation Qualification for a Clean Steam Aenerator

(5)

Appendix 7.B. Sample Equipment Qualification Study Protocol for a Hot Air Curing Oven

100

(4)

Appendix 7.C. Sample Validation Protocol for a Compressed Air Production and Distribution System

104

(5)

Qualification of Software-Driven, Automated Equipment and Equipment Systems

109

(18)

Software-Driven, Automated Equipment Systems

110

(2)

Software Installation Qualification Records

112

(1)

Software Operational Qualification Study Protocols

112

(1)

Software Performance Studies

113

(1)

Where to Start?

114

(1)

Categorization of Concern

114

(1)

Software Requirements

115

(1)

Qualification Data Options for Automated Systems

116

(1)

Simple Equipment Systems Should Require Simple Evaluation

117

(1)

Supporting Qualified, Software-Driven, Automated Equipment Systems

117

(1)

References

118

(1)

Bibliography

118

(4)

Appendix 8.A. Points to Consider: Software Identification and Control

122

(1)

Appendix 8.B. Points to Consider: Hardware and Equipment Configuration Management

123

(2)

Appendix 8.C. Points to Consider: Good Automated Manufacturing Practices

125

(2)

Facility Qualification Studies

127

(14)

Facility Intended Use or Purpose

127

(3)

Facility Requirements and Specifications

130

(2)

New Facility Construction and Renovation

132

(1)

Facility Qualification Study: Overview

133

(1)

Format and Content of a Facility Qualification Study Protocol

134

(5)

Existing Facility Qualification Studies

139

(1)

Changes in a Qualified Facility

140

(1)

Validation Studies at Suppliers or Contractors

141

(12)

Who Is Responsible?

142

(1)

Validation Studies at Suppliers

142

(1)

Managing the Contracts

143

(1)

Changing Suppliers

144

(1)

References

145

(1)

Bibliography

146

(1)

Appendix 10.A. Points to Consider in Contract Relationships

147

(6)

Change Management for Validated Products, Processes, and Methods

153

(10)

Change Detection Programs

154

(1)

Unexpected Change from Suppliers

155

(1)

Unexpected Results from Validated Products, Processes, or Methods

156

(1)

Proposed Changes to Validated Product, Processes, or Methods

157

(1)

When Preapproval from the FDA Is Required

157

(2)

Unexpected Results During a Validation Study

159

(1)

Revalidation Study Protocols

160

(1)

References

160

(1)

Bibliography

160

(3)

Revalidation and Requalification Studies

163

(142)

Revalidation Studies

164

(1)

Time-Based Requalification/Revalidation Studies

165

(1)

How Much Testing Is Enough?

166

(1)

Revalidation Study Protocol

167

(1)

Revalidation/Requalification Study Protocol: Documentation Requirements

168

(1)

Reference

168

(1)

Appendices

A. 21 CFR Part 820-Quality System Regulation

169

(22)

B. Current Good Manufacturing Practice (cGMP) Final Rule: Quality System Regulation

191

(24)

Deign Controls

Production and Process Controls

C. Medical Device Quality Systems Manual: A Small Entity Compliance Guide

215

(52)

Design Controls

Process validation

Equipment and Calibration

D. General Principles of Software Validation

267

(28)

E. Proposed Amendment of Certain Requirements for Finished Pharmaceuticals

295

(10)

Process Validation

Method Validation

Index

305

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Validation for Medical Device and Diagnostic Manufacturers, Second Edition

Summary

Table of Contents

Supplemental Materials