Validation for Medical Device and Diagnostic Manufacturers, Second Edition

by Desain; Carol V.

• ISBN13: 9781574910636
• ISBN10: 1574910639
• Edition: 2nd
• Format: Hardcover
• Copyright: 1997-09-30
• Publisher: CRC Press

Summary

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.

Table of Contents

Introduction	xiii
Introduction to Quality Systems	1	(6)
Quality Control, Quality Assurance, and Quality Systems	2	(1)
Quality System Summary	3	(1)
Quality System Requirements in Five Steps	4	(1)
The Commitment to Validate	4	(1)
Bibliography	5	(2)
Validation Overview	7	(14)
Regulations, Guidelines, and Expectations for Validation Studies	7	(2)
When Are Validation Studies Required? When Are Validation Studies Appropriate?	9	(1)
When Are Validation Studies Performed in the Product Life Cycle?	10	(1)
Design, Process, and Method Validation Relationships	10	(1)
Who Designs and Performs Validation Studies?	11	(1)
When Clinical Use Product Is Produced in the Development Laboratory	12	(1)
Specification Testing	12	(1)
Validation Studies Versus Qualification Studies	13	(1)
Validation Study Strategies	14	(1)
Fundamental Elements of Validation	14	(1)
Validation Terminology and Definitions	15	(1)
Prospective and Retrospective Validation Studies	15	(2)
Revalidation	17	(1)
Summary	18	(1)
A Look Ahead	18	(1)
References	18	(1)
Bibliography	19	(2)
Product Development and Validation	21	(20)
Design Input: Defining the Product Design Endpoint	21	(2)
Designing and Design Analysis	23	(1)
Design Output: Documenting the Design	23	(1)
Design Verification: Demonstrating That the Design Endpoint Is Achievable	24	(2)
Design Validation: Demonstrating That User Requirements Are Satisfied	26	(3)
Medical Device Software Validation	29	(1)
Ensure That Design Verification and Validation Studies Are Meaningful	30	(1)
Design Validation and Design Transfer	31	(1)
The Evolution of Validation for Medical Product Manufacturers	32	(2)
References	34	(2)
Appendix 3.A. Content Considerations for a Design Verification Study Plan and Protocol	36	(1)
Appendix 3.B. Content Considerations for a Design Validation Study Plan and Protocol	37	(2)
Appendix 3.C. Design Transfer Decision Record	39	(2)
Validation Study Plans, Protocols, Reports	41	(8)
Validation Study Master Plans	42	(1)
Validation Study Plans or Protocols	42	(2)
Validation Study Reports	44	(1)
Validation Study Notebooks/Validation Study Files	44	(1)
Validation Study Disposition Records	44	(1)
References	45	(1)
Appendix 4.A. Format and Content Considerations for a Validation Study Master Plan	46	(3)
Process Development and Validation	49	(18)
Process Development	50	(5)
Process Validation Studies	55	(1)
Process Validation Candidates	56	(1)
Validation Studies Can Minimize Process Specification Testing	57	(1)
Are Validation Studies the Only Option?	58	(1)
Who Performs Validation Studies and When?	59	(1)
Process Validation or Qualification Study Protocols: Format and Content Considerations	59	(3)
Equipment-Dependent Processes	62	(1)
Process Failures and Out-of-Specification Results	62	(1)
Revalidation	62	(1)
Summary	63	(1)
Bibliography	63	(1)
Appendix 5.A. Sample Process Validation Study Protocol	64	(3)
Test Method Development and Validation	67	(18)
Test/Inspection Method Validation: Regulatory Requirement or NOT?	68	(1)
The Life Cycle of a Test/Inspection Method	69	(1)
Method Development	70	(4)
Method Control: Is Validation the Only Option?	74	(2)
Who Performs the Study?	76	(1)
Method Qualification or Validation	76	(1)
Study Protocol Format and Content: Test/Inspection Methods	77	(2)
Routine Monitoring of a Validated Test/Inspection Method	79	(1)
Method Failures Versus Out-of-Specification Results	80	(1)
Training of Technicians	80	(1)
In Vitro Diagnostics: When the Test Method Is the Product	81	(1)
Summary	82	(1)
References	82	(1)
Bibliography	83	(2)
Qualification of Equipment and Equipment Systems	85	(24)
What About Equipment Validation?	85	(1)
What Equipment Requires a Qualification Study?	86	(1)
Equipment Qualification Study Protocol: Format and Content	87	(3)
Equipment and Equipment System Development During Start-Up	90	(1)
Use of Contract ``Validation'' Services	91	(1)
New or Existing?	91	(1)
Equipment Versus Equipment Systems	92	(1)
The Commitments of Routine Maintenance, Calibration, and Change Control	93	(1)
Bibliography	93	(2)
Appendix 7.A. Sample Installation Qualification for a Clean Steam Aenerator	95	(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