Practical process validation / Mark A. Durivage, Bob (Bhavan) Mehta.

Format:

Book

Author/Creator:

Durivage, Mark Allen, author.

Mehta, Bob, 1961- author.

Language:

English

Subjects (All):

Process control.

Production control.

Quality control.

Physical Description:

1 online resource (169 pages)

Place of Publication:

Milwaukee, Wisconsin : ASQ Quality Press, [2016]

Summary:

For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards.The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.

Contents:

Cover

Title Page

CIP data

Dedication

Table of Contents

List of Figures and Tables

Preface

Acknowledgments

Chapter 1: Introduction

Chapter 2: Regulatory and Certification Requirements

2.1 FDA Requirements

Subpart G-Production and Process Controls (Code of Federal Regulation 2014)

2.2 Failing to Comply with FDA Requirements

Examples of FDA Warning Letters with Form 483 Observations for 820.75

2.3 ISO Requirements

ISO 13485:2003 and EN ISO 13485:2012

2.4 Path to Certification and Compliance

2.5 Regulatory and Certification Requirements Summary

Chapter 3: Establishing Policies and Procedures

3.1 The Purpose Behind Establishing Process Validation Policies and Procedures

3.2 Validation Policy Statements

3.3 Recommended Procedures in Support of Practical Process Validation

3.4 Writing the Process Validation Procedure

Purpose

Scope

Definitions (Relevant to the Validation Process)

References (Internal and External)

Responsibilities

Validation Requirements (Validation, Documentation)

Process Flow (Validation Planning, Validation Process, IQ, OQ, PQ, and PPQ)

Sample Size Rationale

Data Collection, Statistical Methodology, and Analysis

Handling Deviations

Validation Report

Process Monitoring

Revalidation Requirements

3.5 Summary

Chapter 4: Validation Prerequisites

4.1 Design of Experiments

4.2 Understanding the Importance of Calibration/Metrology

4.3 Ensuring that Test Method Validation (TMV) Activities Have Been Completed

4.4 Training

Basic Training Program Requirements

New Employee Orientation

Quality Management System Training

Career Development Training

Training Methodology

Documentation of Training

4.5 Third-Party Service Providers

4.6 Summary

Chapter 5: Process Validation Considerations.

5.1 Validation or Verification

21 CFR, Part 820, Section 820.75-Process Validation

5.2 Process Validation Planning

5.3 Process Scoping

5.4 Installation Qualification

5.5 Operational Qualification

Equipment

Process

5.6 Performance Qualification

5.7 Process Performance Qualification

5.8 Statistical Methods for Data Collection and Analysis

5.9 Process Validation Reporting

5.10 Process Monitoring

5.11 Decision to Repeat Process Validation

5.12 Conclusion

Chapter 6: Validation Master Plan

6.1 Validation Master Plan Content

6.2 Determining the Need for Validation

6.3 Conclusion

Chapter 7: Software Validation

7.1 FDA Requirements for Software Validation

21 CFR, Section 820.30-Design Controls

21 CFR, Section 820.70-Production and Process Controls

21 CFR, Section 11-Electronic Records

Electronic Signatures

7.2 Determining the Need for Software Validation

7.3 Software Development Life Cycle

Requirements Phase

Design and Development Phase

Software Construction Phase

Software Testing Phase

Software Release Phase

Final Review of the Traceability Matrix

7.4 Creation of the User Requirements Document

7.5 Development of the Project Plan-Master Validation Plan (MVP)

7.6 Creation of the Functional Specifications Document

7.7 Performance of the Gap Analysis

7.8 Writing of the Installation Protocol

7.9 Writing of the Installation Report

7.10 Writing of the Testing Protocol(s)-Validation Protocols

7.11 Final Test Report

7.12 System Release/Go-Live

7.13 Validation Completion

7.14 Repeating Validation

7.15 Summary

Chapter 8: Revalidation and Retrospective Validation

8.1 Retrospective Validation

8.2 Revalidation

8.3 Conclusion

Chapter 9: Sample Size Considerations

9.1 Sampling Plan Standards.

9.2 Sample Size Calculation Based on Confidence and Reliability with Zero Failures Allowed

9.3 Reliability Estimate When Sample Size Is Provided

9.4 Sample Size Calculation with Failures Allowed

9.5 Reliability Estimate When Sample Sizes Are Specified

9.6 Determining the Appropriate Number of Lots

9.7 Conclusion

Chapter 10: Control Charts for Continuous Process Monitoring

10.1 Control Chart Types and Selection

10.2 Control Chart Interpretation

10.3 X-bar and R Control Charts

10.4 X-bar and s Control Charts

10.5 c-Charts

10.6 u-Charts

10.7 np-Charts

10.8 p-Charts

10.9 X and mR (Moving Range) Control Charts

10.10 Conclusion

Chapter 11: Outliers

11.1 Outlier Detection Based on the Interquartile Range

11.2 Dixon's Q Test

11.3 Dean and Dixon Outlier Test

11.4 Grubbs Outlier Test

11.5 Walsh's Outlier Test

11.6 Hampel's Method for Outlier Detection

11.7 Conclusion

Chapter 12: Process Capability

12.1 Process Capability for Variables Data

12.2 Process Capability for Attributes Data

12.3 Conclusion

Chapter 13: Common Validation Issues

13.1 Line Clearance Not Performed

13.2 Deviations-Opening, Investigation, and Closing

13.3 Disposition of OQ Product Produced

13.4 Using a Simulant or Dunnage for OQ

13.5 Bracketing Strategy/Rationale for Family of Parts

13.6 First Article Layout (FAL)/First Article Inspection (FAI)

13.7 Not Producing Enough Samples

13.8 Not Recording the Lot Numbers of the Materials Used During the Validation

13.9 Training

13.10 Establishing Revalidation/Retrospective Validation Criteria and Intervals

13.11 Using Uncalibrated Inspection, Measuring, and Test Equipment (IMTE)

13.12 Not Verifying the Measurement System

13.13 Not Validating Identical Machines

13.14 Not Validating Identical Tooling

13.15 Approvals.

13.16 Change Control

13.17 Not Planning/Performing Continuous Process Monitoring

13.18 Not Having a Validation Master Plan

13.19 Sample Size Not Justified

13.20 The Lack of Predefined Acceptance Criteria

13.21 Conclusion

Appendix A: Distribution of the Chi-Square

Appendix B: Control Chart Constants

Appendix C: Critical Values of the Dean and Dixon Outlier Test

Appendix D: Critical Values for the Grubbs Outlier Test

Glossary

Bibliography

Index.

Notes:

Description based on print version record.

Includes bibliographical references and index.

Other Format:

Print version: Durivage, Mark Allen Practical Process Validation

ISBN:

9781636941028

1636941028

9781636941011

163694101X