Facility Validation: Theory, Practice, and Tools

FACILITY VALIDATION Theory, Practice, and Tools FACILITY VALIDATION Theory, Practice, and Tools Graham C. Wrig...

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FACILITY VALIDATION

Theory, Practice, and Tools

FACILITY VALIDATION Theory, Practice, and Tools

Graham C. Wrigley

CRC PR E S S Boca Raton London New York Washington, D.C.

Library of Congress Cataloging-in-Publication Data Wrigley, Graham C. Facility validation : theory, practice, and tools / Graham C. Wrigley. p. cm. Includes bibliographical references and index. ISBN 0-8493-2340-1 (alk. paper) 1. Pharmaceutical technology—Quality control. 2. Pharmaceutical industry—Standards. I. Title. RS192.W75 2004 615¢.19—dc22

2003065586

The views expressed in this book are provided in good faith and reflect the personal opinion of the author. This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are indicated. A wide variety of references are listed. Reasonable efforts have been made to publish reliable data and information, but the author and the publisher cannot assume responsibility for the validity of all materials or for the consequences of their use. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage or retrieval system, without prior permission in writing from the publisher. The consent of CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new works, or for resale. Specific permission must be obtained in writing from CRC Press LLC for such copying. Direct all inquiries to CRC Press LLC, 2000 N.W. Corporate Blvd., Boca Raton, Florida 33431. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to infringe.

Visit the CRC Press Web site at www.crcpress.com © 2004 by CRC Press LLC No claim to original U.S. Government works International Standard Book Number 0-8493-2340-1 Library of Congress Card Number 2003065586 Printed in the United States of America 1 2 3 4 5 6 7 8 9 0 Printed on acid-free paper

Preface Pharmaceutical companies typically require considerable resources in terms of time, money, and specialized personnel to validate a manufacturing facility, and this can be overwhelming to a small company or plant with limited resources. The cost of validating a plant has increased over the years, reflecting higher standards required by the regulatory authorities or by companies adopting inefficient and ineffective validation practices. Because of the latter problem, the word “validation” still has a negative connotation in the pharmaceutical industry and is still understood by some as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and which serve only to slow progress. In short, validation provides no beneficial contribution to a project — it only adds cost. To analyze and investigate this problem in more depth, this book focuses on validation aspects pertaining to the startup of a new or upgraded manufacturing facility. The “theory, practice, and tools of facility validation” are defined. A scenario is sketched of facility construction costs continuing to escalate with ever-decreasing resources and time allocated to many projects; tied in with this are many far-reaching changes taking place in the application of the current good manufacturing practice (cGMP) regulations relating to the pharmaceutical industry. Regulatory authorities are expecting the rigor of control of pharmaceutical manufacturing to continuously improve over time. This is forcing companies to evaluate their validation programs to investigate ways of streamlining the process of validation. Methods that satisfy quality needs, business needs, and regulatory requirements are used to ensure that the industry remains competitive and compliant in an effective and efficient manner. Various policies, guidelines, and regulations relating to GMP in the pharmaceutical industry worldwide, particularly those regulations affecting the various aspects of facility validation, are defined and described. The relationship between validation and GMP is then further expanded on to define the scope and extent of regulatory requirements for validation. Validation concepts, definitions, and terminology associated with GMP and validation is discussed in an effort to provide some consistency to avoid confusion and misinterpretation of regulatory expectations within the industry. The philosophy and key principles of validation (life-cycle approach to validation and qualification practices) are detailed. What it takes to set up an infrastructure for implementing a validation program to address all of the essential validation disciplines is also presented. The life-cycle approach is presented for the qualification and validation of a pharmaceutical manufacturing facility explaining the sequence of relevant engineering and validation activities typically followed in a project. Common pitfalls and problems associated with facility validation projects are presented to highlight the various difficulties and constraints that a validation team has to manage. © 2004 by CRC Press LLC

Twenty steps and good validation practices are advocated to reduce project resource requirements, project costs, and time schedules, improve commissioning and validation efficiencies, with efficient start-up of the plant. The various benefits of implementing the good validation practices to address the most common problems associated with facility validation projects are expounded. The book warns of dire consequences if companies do not adopt and follow these best practices. This book makes a solid case for the benefits of companies following a simple, practical, scientific validation program that is based on common sense. It demonstrates that design, engineering, commissioning, and validation activities can be integrated and streamlined to accelerate the start-up effort, reduce the validation effort and costs, produce superior documentation, and ensure that product is produced in a cGMPcompliant facility. It proves that even though the original focus of validation was to satisfy regulatory expectations, facility validation has in fact become a good business and engineering practice that enhances reliability, cost, and quality. Properly executed validation pays for itself, often in nonfinancial ways. Validation professionals are challenged to never allow themselves to become complacent about investigating and employing new approaches and technologies and must continue to develop standards and guidelines for increasing the quality, effectiveness, and value of validation activities and to make these available to help companies to keep their good validation practices current in order to control the cost of validation. In this way validation will take the lead, refocus, and begin to dispel the negative perceptions and reverse this disturbing trend toward unnecessary or inefficient facility validation activities to provide positive impact to the corporate bottom line.

© 2004 by CRC Press LLC

Author Graham C. Wrigley, M.Pharm. (Industrial Pharmacy), Ph.D. (Industrial Pharmacy), is a validation manager with a large, multinational pharmaceutical manufacturer. As a pharmacist, Graham has approximately 23 years of broad-based experience in the healthcare industry and more than 12 years of experience with increasing responsibilities in the pharmaceutical industry in the areas of manufacturing, technical and manufacturing services, quality assurance, quality compliance, and validation. Graham has been actively involved with validation issues for 11 years, and has presented and published several papers on the subject of validation at international conferences. He serves as a member of the Journal of Validation Technology Editorial Advisory Board.

© 2004 by CRC Press LLC

Introduction In the past decade, many far-reaching changes have taken place in the application of the current good manufacturing practice (cGMP) regulations relating to the pharmaceutical industry. The words “current” and “good” in cGMP create the expectation for the rigor of control of pharmaceutical manufacturing to continuously improve over time, and convey the notion that as soon as a practice becomes recognized as valuable in assuring the quality of drug products, that practice becomes the standard for the industry. Thus, continuous quality improvement is ingrained in the cGMP concept. In this environment, the pharmaceutical industry also constantly seeks improved manufacturing efficiencies to attain marketplace strategic advantage with “cost of goods” and “speed to market” imperatives and increasingly more costly capital expenditures are devoted to achieving this competitive advantage. These strategies often include building new or modernizing existing manufacturing facilities. The design, construction, commissioning, and validation of these pharmaceutical facilities are significant challenges for project managers, as well as engineering and quality professionals. Constantly caught in a dilemma of budget and schedule constraints, companies have to deliver a quality end product that complies with all building, environmental, health and safety codes, laws, and regulations and in addition they must also comply with one very important legal criterion: They must be validated to meet the cGMP regulations. Historically, the legal requirement for validation in the pharmaceutical industry originated in 1978 in the U.S. with the Food and Drug Administration (FDA) issuing amendments to the Code of Federal Regulations (CFR) that set forth current cGMP regulations (FDA CFR Title 21)1 for the manufacturing, processing, packaging, or holding of human and veterinary drugs. This precipitated a widespread rush by pharmaceutical manufacturers to institute formalized validation programs suited to their individual needs, financial capabilities, and company philosophies. These regulations have been written in such a way as to leave the interpretation to the user, and confusion and misinterpretation by the industry on the scope and extent of this validation requirement has led to ever-increasing costs of bringing pharmaceutical facilities in compliance with these cGMPs. The cost of validating a facility is determined by the time spent on documentation, the development of protocols and SOPs, and the time spent on actual fieldwork, data collection, and analysis.2 These costs have increased over the years, reflecting higher standards required by the regulatory authorities, because industry has adopted inefficient and costly blanket validation compliance strategies. As a result, there is a continuing struggle and challenge to meet regulatory requirements, keep overhead costs down, and run a profitable business. For interest, a good rule of thumb is that,

© 2004 by CRC Press LLC

for typical pharmaceutical plant expansion projects, total “validation costs may run from 4 to 8% of the total project cost.”3 For a new or upgraded facility, commissioning and facility validation is the foundation for assuring success in future manufacturing process validation. Before you begin validating a manufacturing process, an acceptable facility and the utilities and equipment to support manufacturing operations must be in place. Facility qualification and validation activities will establish and provide documentary evidence that: • •

• •

The premises, facilities, and equipment have been designed in accordance with the requirements of cGMP. This constitutes design qualification (DQ). The facilities and equipment have been built and installed in compliance with their design specifications. This constitutes installation qualification (IQ). The facilities, utilities, and equipment operate in accordance with their design specifications. This constitutes operational qualification (OQ). The facilities, utilities, or equipment that can affect product quality performs as intended, meeting predetermined acceptance criteria. This constitutes performance qualification (PQ).4

Process validation can commence once the facility has been validated (IQ + OQ + PQ). A specific process will consistently produce a product meeting predetermined specifications and quality attributes. This constitutes process validation (PV).4 These qualification and validation activities play a crucial role in delivering operationally effective, safe, and efficient facilities, manufacturing process utilities, and equipment, and also provide the medium by which compliance is achieved, demonstrated, and retained. Facility validation represents the last phase of the design and construction of a pharmaceutical facility and is beset by the following major problems: •

•

Validation activities form a significant percentage of time and money in most pharmaceutical capital projects, and the cost of validating and maintaining facilities designed to meet cGMP requirements is spiraling out of control. These costs have increased over the years, reflecting higher standards required by the regulatory authorities as interpreted, and also because industry has adopted inefficient and costly blanket validation compliance strategies. This is because most organizations lack a clear understanding of the reason for validation, fail to develop procedures to allow them to conduct efficient validation, and rarely allow sufficient time and resources to plan for validation activities. Compared to disciplines like chemistry and engineering, validation is a relatively new technology, and many of the people in key senior management positions today do not fully appreciate the extent and scope of validation, the resources required, and its beneficial contribution to a project. This means that validation project teams are often under resourced for the scope and duration of projects.

© 2004 by CRC Press LLC

•

•

Advancing manufacturing technology makes new facilities increasingly more complex and brings higher expectations for output, quality, and efficiency. Fears of plant shut-downs and possible financial losses are forcing validation teams to qualify or validate noncritical cGMP systems that really only require commissioning. Plant commissioning is a vital element in the process of delivering new facilities and represents the last phase of the design and construction of a pharmaceutical facility before validation. Project system and equipment commissioning activities are often not planned sufficiently well and timelines allocated for execution are underestimated. This, together with varying commissioning practices and methodologies, results in costly delays and stressful implementation when project teams undermanage the tasks of starting up and turning over facilities. This lack of effective commissioning and the consequent slippage in the project time line can restrict the amount of time left to do the validation.

Pharmaceutical industries, regulatory authorities, institutions, and corporations in places such as the U.S., Europe, and Japan are harmonizing their regulations and practices relating to cGMP, and nations worldwide are gradually adopting these rules, regulations, and practices. As GMPs must remain current, so too must there be continuous quality improvement over time in what could be termed good validation practice (GVP). Ways of streamlining the process of validation, with methods that satisfy quality needs, business needs, and regulatory requirements must be investigated to ensure that the industry remains competitive and compliant in an effective and efficient manner. This book presents the author’s experience in validating upgraded manufacturing facilities and proposes methodologies to improve, integrate, and streamline the facility validation approaches to control the cost and time of validation, with the resultant efficient start-up of pharmaceutical manufacturing facilities. This book presents, reviews, analyzes, and discusses the following: •

•

•

Chapter 1: The Regulatory Requirements for Validation in the Pharmaceutical Industry • The regulatory requirements of good manufacturing practice (GMP) • The relationship between validation and GMP • The impact of changing regulations on the scope and extent of validation • The future of GMP Chapter 2: The Fundamentals and Essentials of Validation • Validation concepts, definitions, and terminology • The philosophy and key principles of validation • Organizing and planning for validation • The essential validation disciplines Chapter 3: The Practice of Facility Validation • A typical life-cycle approach for the qualification and validation of a pharmaceutical manufacturing facility

© 2004 by CRC Press LLC

•

•

•

Chapter 4: Twenty Tools Recommended for Facility Validation • Common problems associated with facility validation • Good validation practice Chapter 5: Good Validation Practice • Benefits of following good validation practice • Consequences of not following good validation practice Chapter 6: Conclusions and Future Directions

This book offers the industry an opportunity to rethink current practices regarding this powerful and valuable quality system, viz. validation, so that we can address problems and shortcomings, identify inefficient validation activities, and implement new approaches to reduce costs and improve efficiency. The book identifies opportunities for improving the following critical areas in a facility validation project: project organizational structure, project team responsibilities, project scope definition, project planning and scheduling, commissioning program, construction turn-over and plant startup, documentation management, and maintenance of validation status. Validation is a function of risk aversion and the cost of validation is related to the amount of (quality) risk that we wish to avert.5 This book demonstrates that design, engineering, commissioning, and validation activities can be integrated and streamlined to accelerate the startup effort, reduce the validation effort and costs, produce superior documentation, and ensure that product is produced in a cGMPcompliant facility. It also proves that even though the original focus of validation was to satisfy regulatory expectations, facility validation has in fact become a good business and engineering practice that enhances reliability, cost, and quality. The information presented in this book will provide: •

•

•

Practical approaches that may be used for integrating the commissioning and validation of GMP facilities for companies new to validation or companies with limited validation resources. Guidelines to pharmaceutical manufacturers, engineering, quality, and validation professionals for assessing the detail, efficiency, quality, and cost of their programs and will describe some of the practical approaches that may be used to facilitate new facility startup and operation. A positive contribution to the future cGMP standards to be set by the regulators of the pharmaceutical industry.

References 1. Food and Drug Administration (FDA), CFR, Title 21 (Food and Drugs), Rockville, MD, 2001, Parts 200–299. Available: http://www.cfsan.fda.gov 2. Stocker, A.C., Why does validation cost so much and take so long? (and what we can do about it), J. Validation Technol., 1(1), (Jan) 5, 1994. 3. Gloystein, L., Protocol structure and IQ/OQ costs, J. Validation Technol., 3(2), (Feb) 140, 1997. 4. Auterhoff, G., PIC recommendations on validation, J. Drugs Made in Germany, 39(3), (Jan) 84, 1996. 5. Hargroves, J., Cost-effective approaches to validation, J. Validation Technol., 3(2), (Feb) 132, 1997. © 2004 by CRC Press LLC

Contents Chapter 1

The Regulatory Requirements for Validation in the Pharmaceutical Industry

1.1

The Regulatory Requirements of Good Manufacturing Practice (GMP) 1.1.1 Buildings and Facilities 1.1.1.1 GMP Principles 1.1.2 Equipment 1.1.2.1 GMP Principles 1.2 The Relationship between Validation and GMP 1.2.1 Compliance 1.2.2 Quality Assurance 1.2.3 Economics 1.3 The Impact of Changing Regulations on the Scope and Extent of Validation 1.4 The Future of GMP References

Chapter 2

The Fundamentals and Essentials of Validation

2.1 2.2

Validation Concepts, Definitions, and Terminology The Philosophy and Key Principles of Validation 2.2.1 The Life-Cycle Approach to Validation 2.2.2 Qualification Practices 2.3 Organizing and Planning for Validation 2.3.1 Organizing for Validation 2.3.2 Planning for Validation 2.4 The Essential Validation Disciplines References

Chapter 3 3.1

The Practice of Facility Validation

A Typical Life-Cycle Approach for the Qualification and Validation of a Pharmaceutical Manufacturing Facility 3.1.1 The Requirements and Specification Phase 3.1.2 Validation Planning 3.1.3 The Validation Project Team 3.1.4 Facility Systems GMP Audit, Design Qualification, and Impact Assessment 3.1.5 Factory Acceptance Tests (FATs) and Predelivery Inspections (PDIs)

© 2004 by CRC Press LLC

3.1.6 3.1.7 3.1.8 3.1.9 3.1.10 3.1.11 References

Commissioning Installation and Operational Qualification (IQ/OQ) Performance Qualification (PQ) Related Compliance Programs Plant Release and Start-Up Periodic Review, Change Control, and Revalidation

Chapter 4

Twenty Tools Recommended for Facility Validation

4.1 4.2 4.3

Common Problems Associated with Facility Validation Good Validation Practice Step 1: Structure the Project Team Appropriately; Define Functions, Roles, and Responsibilities 4.3.1 Project Team Structure 4.3.2 Project Team Function 4.3.3 Project Team Roles and Responsibilities 4.4 Step 2: Get Project Team Buy-In 4.5 Step 3: Educate Project Team 4.6 Step 4: Involve Quality Assurance 4.7 Step 5: Encourage Greater End-User/Stakeholder Participation 4.8 Step 6: Conduct Quality Compliance Audits of Prospective Vendors 4.9 Step 7: Give Vendors the Information Needed to Succeed 4.10 Step 8: Define Validation Scope; Conduct Impact Analysis Early 4.11 Step 9: Develop a Robust Validation Master Plan 4.12 Step 10: Integrate Validation Schedules into the Overall Project Schedule 4.13 Step 11: Adopt Formal Commissioning Procedures 4.14 Step 12: Standardize Validation Approach SOPs/Guidelines; Educate Validators 4.15 Step 13: Avoid Duplicate Testing; Integrate Commissioning with Validation Activities 4.16 Step 14: Formalize Turn-Over Process and Turn-Over Package Documentation Requirements 4.17 Step 15: Begin Facility-Related Compliance Programs Early 4.18 Step 16: Enhance Documentation and Documentation Management Practices 4.19 Step 17: Conduct Periodic Design and Construction Reviews 4.20 Step 18: Hand-Over and Train End Users in Validated Systems 4.21 Step 19: Develop a Revalidation Strategy to Maintain a Validated System or Equipment 4.22 Step 20: Continuously Improve and Maintain Validation Practices; Reapply Lessons Learned from Previous Projects References

© 2004 by CRC Press LLC

Chapter 5

Good Validation Practices

5.1 5.2

Benefits of Following Good Validation Practices Consequences of Not Following Good Validation Practices 5.2.1 Total Validation Duration and Costs References

Chapter 6

Conclusions and Future Directions

References

Chapter 7

Glossary of Definitions and Terms Associated with Validation

References

© 2004 by CRC Press LLC

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TABLE 1.1 WHO GMP Requirements for Pharmaceutical Products

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TABLE 1.2 FDA Requirements for GMP

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1.1.1 BUILDINGS

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TABLE 2.1 Number of Employees Engaged in Validation of Nonsterile Productsa

Structure

Approximate Number of Products

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Technicians

Approach

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TABLE 2.2 Checklist of Validation and Control Documentation Subpart

Section of cGMP

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3.1.1 THE REQUIREMENTS

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Engineering

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User Requirement/Design Spec.

Functional and Detail Design

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Correct design deficiencies

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Factory Acceptance Test (FAT)

Generate and address Punch list

Install

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Commission

Formal IQ/OQ Generate and address Punch list

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4.2 GOOD VALIDATION PRACTICES ,WLVHYLGHQWIURPWKHH[SHULHQFHVPHQWLRQHGKHUHWKDWWKHUHLVDIXQGDPHQWDOÁ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ÀFLHQW´WUDGLWLRQDOµYDOLGDWLRQPHWKRGRORJLHV ZKLFKWKH\GHÀQHGDV´TXDVLYDOLGDWLRQµ$QHZVWUHDPOLQHGYDOLGDWLRQDSSURDFKZDV GHÀQHGDVDWDUJHWHGUHVROXWHPHWKRGRISODQQLQJLQIRUPHGGHFLVLRQPDNLQJDQG WHVWLQJWKDWDOORZVWKHYDOLGDWLRQDFWLYLWLHVWREHGHYHORSHGDQGH[HFXWHGUDSLGO\DQG © 2004 by CRC Press LLC

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4.3.1 PROJECT TEAM STRUCTURE 'HWHUPLQDWLRQRIWKHVNLOOVHWQHHGHGWRFRPSOHWHWKHSURMHFWLVWKHSURMHFWPDQDJHU·V UHVSRQVLELOLW\7RRRIWHQWKLVSUHOLPLQDU\HYDOXDWLRQLVQHYHUSHUIRUPHGZKLFKFDQ KDYHDGUDPDWLFLPSDFWRQWKHFRVWDQGTXDOLW\RIWKHSURMHFW3URMHFWWHDPUHSUHVHQ WDWLRQ VKRXOG EH EDVHG RQ WKH SURMHFW VFRSH UHVRXUFH UHTXLUHPHQWV DQG WKH NH\ VWDNHKROGHUVLPSDFWHGE\WKHSURMHFWRXWFRPH © 2004 by CRC Press LLC

TABLE 4.1 20 Steps for Successful Facility Validation Step

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4.3.2 PROJECT TEAM FUNCTION ([SHULHQFHKDVVKRZQWKDWWKHSUHOLPLQDU\GHÀQLWLRQRIWKHSURMHFWIXQFWLRQVFRSH UROHV DQG UHVSRQVLELOLWLHV DQG WHDP LQWHUGHSHQGHQFLHV QHHG WR EH HVWDEOLVKHG DQG GRFXPHQWHG,IWKLVLVQRWGRQHLWRIWHQFDQOHDGWRWKHVLWXDWLRQZKHUHSURMHFWWHDP PHPEHUV·QRUPDOUHVSRQVLELOLWLHVFRQÁLFWZLWKWKHLUSURMHFWUHVSRQVLELOLWLHV$WWKH © 2004 by CRC Press LLC

Project Sponsor Company Managing Director

Project Manager Assigned Functional Manager

Operations Production Manager

Quality Assurance Quality Operations Manager

Engineering Engineering Manager

Regulatory Affairs Regulatory Affairs Manager

Environment, Health & Safety EHS Manager

Validation Validation Manager

Business Technology BT Manager

Analytical Technology AT Manager Quality Control Manager

Supply Chain Supply Chain Manager

Pharmaceutical Technology R&D Manager

Training Technical Training Manager

Finance Finance Manager

Consultants/Vendors Architect/Engineer/Contractor Validation Equipment Vendor

Documentation Technical Writers

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© 2004 by CRC Press LLC

Project Name: Sub-Team Strategy Document Date Submitted:

Revision #:

Team Mission: Project Clarification Statement: In Scope: Out-of-Scope: Team Critical Success Factors: Team Objectives and Milestones: Team Major Project Influencers: Team Leader:

Sponsor:

Team Members:

Team Members (cont.):

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Tablet Upgrade Validation Project Plan Project Goals • To validate/qualify the facility, utilities, equipment, and processes according to corporate requirements • To complete the execution of some 40 validation/qualification protocols within the overall project phase time lines and budget Scope of the Validation/Qualification Plan • Facility qualification • Utility qualification • New equipment qualification • Existing equipment requalification • Computer-related systems validation • Process validation Facility Qualification • Verification of design and installation within specifications for its intended use. • Materials of construction (walls, doors, floors, ceilings) • Electrical installation • Lighting Utility Qualification • HVAC (and AHUs) • Compressed air • Steam • New/existing equipment utility qualification New Equipment Qualification • List equipment in scope of validation plan Computer-Related System Validation • List systems in scope of validation plan Process Validation • List demonstration and validation batches required to be manufactured Critical Milestones • Qualification of the facility and utilities for use • Qualification/requalification of the equipment • Completion of demonstration batches • Completion of validation batches Critical Success Factors • Sufficient validation resources to support the validation plan • No unexpected delays or issues holding up the installation of equipment or utilities • Production and engineering support for the qualification efforts • Management of change control during the period of upgrade • Provision of complete technical design and commissioning documentation • Project time lines and cost

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4.8 STEP 6: CONDUCT QUALITY COMPLIANCE AUDITS OF PROSPECTIVE VENDORS 3URMHFW TXDOLW\ FRQWURO VWDUWV ZLWK WKH SUHTXDOLÀFDWLRQ RI WKH DSSURSULDWH YHQGRUV DQGFRQWUDFWRUVWKDWFRXOGEHLQYROYHGLQWKHSURMHFW3KDUPDFHXWLFDOPDQXIDFWXUHUV QHHGWRKDYHDKLJKOHYHORIFRQÀ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·VYDOLGDWLRQ 6HFRQGDU\DXGLWREMHFWLYHVSURYLGHEXVLQHVVDVVXUDQFHVRIÀQDQFLDOKHDOWKDQG VWDELOLW\IRUORQJWHUPFXVWRPHUUHODWLRQVKLSVDQGVXSSRUW © 2004 by CRC Press LLC

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4.9 STEP 7: GIVE VENDORS THE INFORMATION NEEDED TO SUCCEED $ODFNRIGHÀQLWLRQRIUHTXLUHPHQWVDQGVSHFLÀFDWLRQVDORQJZLWKLQDGHTXDWHGRFX PHQWDWLRQDUHSHUKDSVWKHOHDGLQJFDXVHVRIIDLOXUHRIYDOLGDWLRQHIIRUWV$FRPPRQ FRPSODLQWDPRQJYHQGRUVLVWKDWWKH\GRQRWUHFHLYHFOHDUFRQFLVHRUFRPSOHWHXVHU UHTXLUHPHQWRUUHTXLUHPHQWVSHFLÀFDWLRQGRFXPHQWVIURPWKHLUFXVWRPHUV0RUHRIWHQ WKDQ QRW WKH H[DFW UHTXLUHPHQWV RI D QHZ RU LPSURYHG V\VWHP DUH QRW FRPSOHWHO\ GHÀQHGZKHQWKHIDFLOLW\LVEHLQJGHVLJQHGDQGHTXLSPHQWLVEHLQJVSHFLÀHG+RZHYHU ZHGRJHQHUDOO\NQRZWKHGRFXPHQWDWLRQWKDWZHZLOOUHTXLUHIRUYDOLGDWLRQ 2QFHVXLWDEOHYHQGRUVDUHFKRVHQLWLVQHFHVVDU\WRSURYLGHWKHVHYHQGRUVDQG WKHLUVXEFRQWUDFWRUVZLWKWKHSURMHFWYDOLGDWLRQUHTXLUHPHQWVWRHQDEOHWKHPWRSODQ LQVWDOODWLRQVWRPHHWWKHVHUHTXLUHPHQWV7DEOHSURYLGHVWKHOLVWRIFULWLFDOGRF XPHQWVUHTXLUHGIRUYDOLGDWLRQ7KLVOLVWLQHIIHFWPLUURUVWKH+9$&YHQGRUFKHFNOLVW SUHVHQWHGLQ)LJXUH 7KLV GRFXPHQWDWLRQ LV FULWLFDO IRU WKH GHYHORSPHQW RI TXDOLÀFDWLRQYDOLGDWLRQ SURWRFROV DQG LW LV DOVR LPSRUWDQW WR OHW WKH YHQGRUV NQRZ DW ZKDW SKDVH RI WKH SURMHFW LPSOHPHQWDWLRQ WKHVH GRFXPHQWV ZLOO EH UHTXLUHG WR HQDEOH WKH YDOLGDWLRQ WHDPWRGHYHORSWKHLUSURWRFROV7KHTXDOLW\RIWKHGRFXPHQWDWLRQLVYHU\OLNHO\WR KDYHJUHDWLPSDFWRQWKHTXDOLW\RIWKHSURWRFROVDQGKHQFHRQWKHYDOLGDWLRQVWXGLHV $VDQRWKHULQLWLDWLYHDOOQHZSODQWHTXLSPHQWFDSLWDOSURMHFWVFRXOGEHLQLWLDWHG ZLWKWKHGHYHORSPHQWRIDIRUPDOL]HGXVHUUHTXLUHPHQW85 GRFXPHQWWKDWVSHFLÀHV HTXLSPHQWIXQFWLRQDOLW\DQGGRFXPHQWDWLRQUHTXLUHPHQWV )LJXUHRXWOLQHVDQH[DPSOHRIDGRFXPHQWWKDWFRXOGEHVHQWWRDSURVSHFWLYH YHQGRU7KHYHQGRUWKHQSUHSDUHVDGHVLJQVSHFLÀFDWLRQEDVHGRQWKHXVHUUHTXLUH PHQWV,424VZLOOWKHQEHYHULÀHGDJDLQVWWKHVHGHVLJQVSHFLÀFDWLRQV

© 2004 by CRC Press LLC

SUPPORTIVE DOCUMENTATION REQUIREMENTS FOR HVAC VENDORS The purpose of the following list is to set out the requirements for documentation on the construction, installation and commissioning of Heating, Ventilation and Air-Conditioning (HVAC) Systems: Installation, Commissioning and Validation Documentation: 1. 2.

Description of the system operation and control Verification that the duct material and construction is in accordance with SABS 1022 and SABS 12381979 respectively. 3. Material specifications and make of duct seam sealant. 4. Material specifications and make of detergent used to clean ducting prior to installation. 5. Material specifications of fire retardant duct insulation 6. Verification that method of installation, testing and balancing was in accordance with SABS 01731980 and results of tests. 7. Verification of pipe (water; steam and condensate; compressed air) installation testing (weld and leak tests), where appropriate 8. Operating and Maintenance Instruction Manuals (contents as per attached guideline) 9. “As-Built” Drawings 10. Wiring and Control Diagrams 11. Commissioning Test Report reflecting the verification of design vs. as-built data: • Duct leak test results • Supply and Return Air volumes • Air change rates • Air flow patterns • Room pressures • Room differential pressures • Room air humidity • Room air temperatures • HEPA filter integrity (DOP) test results • Room particle counts • HVAC control verification • Calibration certificates of testing instrumentation 12. Calibration certificates of installed instruments and gauges (where applicable) 13. Register of Training provided by contractor to Company employees 14. Certificate of Completion and Handover (signed by Consulting Engineer and Contractor) 15. Electrical Installation Compliance Certificate 16. Data sheets (e.g. manufacturer, model/serial no., capacity/size/rating, no. off, supplier) of all mechanical components such as: • AHU casing • Supply/exhaust air fan and motor • Heating and cooling coils • Condensing Units • Primary/secondary/HEPA filters • Steam humidifier and valve • Chemical dehumidifier • Electrical duct heaters • Diffusers/grilles/louvers • Pressure control dampers • Volume control dampers • Differential pressure gauges 17. Data sheets (e.g. manufacturer, model/serial no., capacity/size/rating, no. off, supplier) of all electrical components such as: • AC Control Panel • SA fan variable speed drives • UPS Control Panel 18. Data sheets (e.g. manufacturer, model/serial no., capacity/size/rating, and no. off, supplier) of all control system components such as: • Controller • Chilled Water Control Valves and Actuators • Steam Humidifier Control Valve Actuator • Humidity and Temperature Sensors • Duct Humidity and Temperature Sensors • Room Temperature Sensors • Differential Air Pressure Sensor • Air Differential Pressure Switch 19. Recommended Spare Parts List

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© 2004 by CRC Press LLC

TABLE 4.3 List of Critical Documents Required for Validation Document Category 'HVLJQGRFXPHQWV(QJLQHHULQJGUDZLQJV 3 ,'PHFKDQLFDOHOHFWULFDOLVRPHWULF HWF VSHFLÀFDWLRQVPDWHULDORI FRQVWUXFWLRQFDSDFLW\VSHHGFRQWURO UHTXLUHPHQWVHWF 2SHUDWLRQDQGPDLQWHQDQFH2 0 PDQXDO 6WDUWXSDQGPDLQWHQDQFHSURFHGXUHV HTXLSPHQWVHTXHQFHRIRSHUDWLRQV LQVWUXPHQWOLVWVPDWHULDOFHUWLÀFDWLRQVSDUH SDUWVOLVWHWF &RQVWUXFWLRQDQGLQVWDOODWLRQGRFXPHQWV $VEXLOWGUDZLQJVSXUFKDVHRUGHUVZHOG ORJVSDVVLYDWLRQUHFRUGVFOHDQLQJ FHUWLÀFDWHVFKDQJHRUGHUVHWF &RPPLVVLRQLQJGRFXPHQWV+9$&EDODQFH UHSRUWGXFWOHDNWHVWUHSRUWÀOWHULQWHJULW\ UHSRUWFRPPLVVLRQLQJSURFHGXUHHWF 7HFKQLFDOVXSSRUWGRFXPHQWV&KDQJHFRQWURO SURFHGXUHWHVWPHWKRGVFDOLEUDWLRQ SURFHGXUHVHWF

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4.10 STEP 8: DEFINE VALIDATION SCOPE; CONDUCT IMPACT ANALYSIS EARLY 7KHNH\WRVXFFHVVIXOSURMHFWLPSOHPHQWDWLRQLVDZHOOGHÀQHGSURMHFWVFRSHZKLFK HQDEOHVWKHYDOLGDWLRQWHDPWRIRFXVRQLWVGHÀ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© 2004 by CRC Press LLC

INTRODUCTION Our company requires a tank mixer for use in the Liquids Department. This mixer shall be used for mixing semiviscous to viscous liquids. This document details the company’s requirements, i.e., Engineering and Quality requirements to ensure that the mixer is designed and installed correctly and operates as expected. It is the responsibility of the Supplier to ensure that this document is read and that all our requirements are met. A period of five (5) working days is allowed for response to this document. In the event that a requirement cannot be met, the Supplier must submit a written document detailing which requirements cannot be met with the appropriate justification. RESPONSIBILITIES Supplier: Oversees the installation to ensure that it is performed as per specifications; Ensures timely provision of data and documents as specified in this document; Reports any anomalies during the installation and commissioning. Company: Ensures that the equipment is installed as per supplier instructions and specifications; Reports any anomalies to the supplier if encountered during the installation phase; Ensures that maintenance and calibration requirements are as per manufacturer recommendations. REQUIREMENTS Quotation: A detailed quotation is required providing the cost of the equipment, cost of spares, and other miscellaneous costs (installation/commissioning/training etc). Technical Requirements: Heavy duty top entry mixer; Flameproof electric motor; Dual impellers of adequate diameter; 316 grade stainless steel (impellers, shaft, fasteners); Frequency inverter (for variable speed); Adjustable top impeller; Compatible with 380V, 3 phase electrical supply; All lubricants to be food grade Additional information required: Maximum shaft stress; Material of construction for all seals; Mass of mixer (including motor); Welding method; Passivation procedure; Tank turnover rate; Shaft length and diameter; Impeller diameters; Mixing action; Lubricant type; Motor output speeds Equipment Spares: The supplier must provide the company with a priced recommended spare parts list; The list must clearly state for which component of the equipment the spares are intended and must be cross-referenced to the equipment part list and drawings; Delivery times for the individual items must be specified and imported components must be clearly identified. Documentation, Data, and Drawings: The following documents are required prior to or with the receipt of the equipment: Product warranty; Commissioning report; Materials of Construction certificates; Operating/Instruction manual-with troubleshooting; Maintenance and Calibration information; Spare parts list; Special cleaning requirements; Calibration certificates traceable to a National Standard; Certification that equipment is safe and complies with the Occupational Health and Safety Act; Drawings (As-built and Wiring/Electrical) All documentation and drawings shall have a title, date, and revision number. Equipment shall not be accepted if not accompanied by the documentation requested. Commissioning: All documentation, as requested in point above, should be provided. The company shall be allowed to inspect the supplier’s installation and shall have the authority to reject any work or material that does not comply with the approved specifications. The company must authorize any deviation from the approved specifications. Authorization for such deviations can only be obtained in writing and must be signed by the concerned parties. All test procedures must be indicated and signed-off. The supplier must generate a commissioning report. A Certificate of Compliance must be issued. The guarantee shall only be effective on the date of official hand-over.

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© 2004 by CRC Press LLC

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TABLE 4.5 Validation Master Plan Matrix of Systems Subject to GEP or Validation System Description

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TABLE 4.6 Sample Components of the Validation Master Plan Section

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© 2004 by CRC Press LLC

Equipment Installation/Qualification Project Team Meeting Present: Validation Manager (recorder); Engineering Reps; Validation Reps. Copy: Production; EHS; Quality Assurance and R&D Reps. Project mission Project timelines Project resources

Validation scope

Equipment 1 Equipment 2 Equipment 3 Equipment 4 Equipment 5 Equipment 6 Equipment 7

Relocation, installation and requalification of granulation processing equipment in the upgraded Tablet Granulation facility on a phased basis. Tentative dates: 1st until 22 nd December. Timelines to be further negotiated with Production and Planning. Contracted to co-ordinate the relocation and installation of the equipment; Validation team to work through shutdown to ensure readiness of equipment by 2nd week of January 2003; Engineering (electrician & calibration) support to be decided on. Pre-validation requirements: critical instruments to be recalibrated; safety assessments to be conducted; SOPs to be reviewed and retrained. Focus will be on the verification of connection of utilities (electricity; compressed air; AHUs and dust extraction); equipment functionality; safety aspects; instrumentation calibration; operator training. Equipment drawings and wiring diagrams to be updated with the installation – resource to be decided on. Retrofit expected to be completed by mid November – can be installed and requalified if AHU has been installed. Can be installed and qualified beginning of November. Sufficient air pressure to be provided for air seals. Decision to be made about PM or replacement of point-of-use compressed air filter on reinstallation. Air quality to be retested by. To be sited in the cubicle 4. Temporary access to suite to be provided for access of operators. Can be installed and qualified beginning of November. Safety proximity switch/interlock to be decided on. Expected to be completed by end November – can be installed and qualified. Qualification to start end October.

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© 2004 by CRC Press LLC

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TABLE 4.7 Typical Commissioning Deliverables

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4.14 STEP 12: STANDARDIZE VALIDATION APPROACH SOPS/GUIDELINES; EDUCATE VALIDATORS ,WZRXOGEHVLPSOHLIWKHUHZHUHDVLQJOHIRUPDWDQGDSSURDFKWRYDOLGDWLRQDFWLYLWLHV 6DGO\WKHUHLVQRW+RZHYHURQHFDQVWDQGDUGL]HYDOLGDWLRQJXLGLQJSULQFLSOHVDQG JHQHUDODSSURDFKHVWKDWFRXOGKHOSVRUWRXWZKRZKDWZKHUHDQGKRZWKHYDOLGDWLRQ LVFRQGXFWHG 1RUPDOO\ELJJHUFRUSRUDWLRQVJLYHEURDGYDOLGDWLRQFRPSOLDQFHJXLGHOLQHVIRU WKHLUSODQWVWRFRPSO\ZLWKEXWWKHGHWDLOVRQZKRZKDWZKHUHDQGKRZDUHQRW VWLSXODWHG ZKLFK RIWHQ OHDGV WR YDULRXV LQWHUSUHWDWLRQV ,W LV LQFXPEHQW RQ WKH LQGLYLGXDOSODQWWRGHYHORSDIRUPDOL]HGSROLF\WKDWVSHFLÀFDOO\DGGUHVVHVWKHRYHUDOO FRPSDQ\SKLORVRSK\DQGPHWKRGRORJ\IRUYDOLGDWLRQDFWLYLWLHV ,Q DGGLWLRQ WR H[SODLQLQJ WKH YDOLGDWLRQ SKLORVRSK\ DQG DSSURDFK LQ D 903 GHWDLOHG 623V RU JXLGHOLQHV FDQ EH ZULWWHQ IRU HYHU\ FULWLFDO DVSHFW RI YDOLGDWLRQ © 2004 by CRC Press LLC

TABLE 4.8 HVAC Commissioning Report Example Air Flow Direction in Accordance with HVAC Design (Y/N) Design and Measured Air Quantities: Supply Air

Room

Location#

Design Air Qty m3/s

Upper Limit m3/s

Measured Capacity m3/s

Pass or Fail

Air Flow m3/s

Air Change/h

Pass or Fail

Lower Limit

Measured Condition (Relative)

Pass or Fail

Lower Limit m3/s

Air Change Rates1 Room

Air Flow m3/s

Room Vol/m3

Air Change/h

Room Pressures

Room

Design Condition (Relative)

Design Condition (Absolute)

Upper Limit

Room Temperature and Humidity (Relative and Absolute)

Room

Design Condition

Upper Limit

Lower Limit

Measured Condition (Maximum)

Measured Condition (Minimum)

Pass or Fail

Lower Limit m3/s

Measured Capacity m3/s

Pass or Fail

Dust Extraction

Room

Service Panel #

Design Air Flow m3/s

Upper Limit m3/s

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TABLE 4.9 Typical Equipment Qualiﬁcation SOP Contents 2EMHFWLYH

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DOCUMENT APPROVAL INTRODUCTION Objective Rationale Scope Exclusions and Assumptions Handling Deviations and Corrective Actions Equipment Description RESPONSIBILITIES QUALIFICATION TEST PLAN Installation Qualification (IQ) Purpose Installation Verification Qualification Data Sheets Equipment Summary Information Equipment Component Verification Identification of Equipment Controls, Indicators, and Instruments Compressed Air Installation Electrical Installation Filter Information Materials of Construction Calibration Information Maintenance Requirements Equipment Manuals Equipment Drawings Safety Assessment Operational Qualification (OQ) Purpose OQ Test Standard Operating Procedures and Training Performance Qualification (PQ) Purpose PQ Test TEST INSTRUMENTATION SUMMARY OF DEVIATIONS DISCUSSION AND CONCLUSIONS FINAL PROTOCOL APPROVAL FORM

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4.15 STEP 13: AVOID DUPLICATE TESTING; INTEGRATE COMMISSIONING WITH VALIDATION ACTIVITIES 7KHUHDUHDGYDQWDJHVRIWLPHPRQH\DQGTXDOLW\LQLQWHJUDWLQJPDQ\RIWKHIXQFWLRQV FDUULHGRXWE\VNLOOHGUHVRXUFHVVXFKDVHQJLQHHULQJDQGYDOLGDWLRQWHDPV$JUHDW GHDORIYDOLGDWLRQZRUNWKDWWUDGLWLRQDOO\KDVEHHQFDUULHGRXWVHSDUDWHO\IURPWKH HQJLQHHULQJZRUNFDQEHDVVRFLDWHGZLWKWKHHQJLQHHULQJDQGFRPPLVVLRQLQJRID IDFLOLW\DQGEHLQWHJUDWHGLQWRWKHSURMHFWVSKHUH7KHUHVSRQVLELOLW\IRUWLPHO\DQG DSSURSULDWHH[HFXWLRQWKHQEHFRPHVWKDWRIWKHFRPELQHGYDOLGDWLRQDQGHQJLQHHULQJ WHDPVRWKDWWKH\EHFRPHLQGLVSHQVDEOHWRHDFKRWKHUDQGUHGXFHWLPHVSHQWRQJHWWLQJ WKHIDFLOLW\YDOLGDWHGDQGZRUNLQJ7KHXVHRIDFRPSHWHQWH[SHUWPXOWLGLVFLSOLQDU\ © 2004 by CRC Press LLC

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DOCUMENT APPROVAL INTRODUCTION Objective Scope Exclusions and Assumptions Deviations and Corrective Actions System Description RESPONSIBILITIES QUALIFICATION DATA SHEETS Installation Verification Installation/Operational Documentation Verification Design Specifications As-Built Drawings Equipment Identification Materials of Construction Mechanical Installation Filter Installation Chilled Water Installation Verification Electrical Installation Identification of Controls, Indicators and Instrumentation HEPA Filter Integrity Test Reports Safety Inspection Report Preventative Maintenance and Calibration Program Calibration Certificates Operational Verification Controls Operation AHU Operating Parameter Control Room Temperature and Relative Humidity Room Pressurization Air Change Rates Air Particle Counts Viable Air Sampling (Environmental Monitoring) SOPs and Training TEST INSTRUMENTATION SUMMARY OF DEVIATIONS FINAL PROTOCOL APPROVAL FORM

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TABLE 4.10 An Example of Integrating Commissioning and Validation Tests Phase where Testing Is Conducted Commissioning Phase FBD Tests/Veriﬁcations )XQFWLRQDOGHVLJQVSHFLÀFDWLRQYHULÀFDWLRQ'4 $VEXLOWDQG3,'GUDZLQJVYHULÀFDWLRQ 0DWHULDOVRIFRQVWUXFWLRQYHULÀFDWLRQ :HOGLQJLQIRUPDWLRQYHULÀFDWLRQ &ULWLFDOFRPSRQHQWYHULÀFDWLRQ &RQWUROV\VWHPFRPSRQHQWYHULÀFDWLRQ ,QVWUXPHQWFDOLEUDWLRQYHULÀFDWLRQ $ODUPVDQGLQWHUORFNVWHVWLQJ )%'VHTXHQFHRIRSHUDWLRQWHVWLQJ )%'UHFLSHKDQGOLQJDQGUHFRYHU\WHVWLQJ &RQWUROV\VWHPVHFXULW\DFFHVVWHVWLQJ )%'RSHUDWLQJSDUDPHWHUFRQWUROWHVWLQJ

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TABLE 4.11 Factory Acceptance Testing Conducted at FBD Vendor Facility 9HQGRU SHUVRQQHO SUHVHQW 3XUFKDVHRUGHU FRQÀUPDWLRQ )DFWRU\ DFFHSWDQFH WHVWLQJ FRQGXFWHG

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MNF. PROCESS VALIDATION

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VALIDATION

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:DON7KURXJK7HDP Project Completion Checklist

Protocol Generation Documentation

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TABLE 4.13 An Example of a Typical Training Matrix Equipment 1

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© 2004 by CRC Press LLC

Completion (%) 100 80 100 75 100 50 100 65 80

Project Name Product 1 Product 2 Equipment 1 Equipment 2 Facility 1 Facility 2 Utility 1 Utility 2 Computer System 1

Project Description Process Validation Process Validation Equipment IQ/OQ/PQ Equipment IQ/OQ/PQ Facility IQ Facility IQ Utility IQ/OQ Utility IQ/OQ Computer Validation

Category Process Process Equipment Equipment Facility Facility Utility Utility Computer

Due Date June 2003

May 2003 July 2003 May 2003 July 2003 May 2003 August 2003 August 2003

FIGURE 4.11 9DOLGDWLRQGRFXPHQWDWLRQDQGSURWRFROGDWDEDVH

© 2004 by CRC Press LLC

Completed May 2003

Tablets Granulation Equipment Qualification/Requalification Punch List Copy: Projects; Engineering; Validation; Production. Equipment 1

1. All utilities to be color coded and direction labels attached 2. Control cabinets to be air conditioned 3. Safety testing certificates for Lifting Device required

Equipment 2

1. Tamper-proof protection required for mixer/chopper seal rotameters 2. Bowl ring limit switch tolerance to be adjusted 3. SOP draft for operation written 1. SOP draft for operation written 2. Relocate emergency stop button on top of the machine so that it doesn’t obscure the oil dipstick 1. Load test certification required 2. Jaws to be modified 1. Magnehelic gauges over the filters require labeling for identification of operating pressures and filter change pressures. 2. SOP for operation written Electrical compliance certificate required 1. SOP draft for cleaning written 1. Quality testing of compressed air to be scheduled in May 2. Compressed air and steam drawings to be red-lined or updated

Equipment 3 Lifting Columns Equipment 4 Equipment 5 Equipment 6 General

FIGURE 4.12 3URMHFWSXQFKOLVWH[DPSOH

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4.21

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EQUIPMENT / UTILITY / FACILITY CHANGE REQUEST Change Request No.: Equipment/Utility/Facility Change: Originating Department: Asset No:

(Mark appropriate box with an X)

Reason for Change: ▫ Equipment Change ▫ Audit Action ▫ Other CHANGE CONTROL REQUEST EVALUATION CHECKLIST Brief description of change: Brief description of reason for proposed change: Location of Department: 1. Systems affected: ▫ Process ▫ Facility ▫ Software ▫ Architectural ▫ Utility ▫ Other (list) 2. Process System Component Affected: ▫ Pump ▫ Valve ▫ Piping ▫ Tanks ▫ Meters ▫ Other (list) 3. Will any components require calibration/recalibration? ▫ No ▫ Yes (list) 4. If yes, has form been submitted and approved by Quality? ▫ Yes ▫ No 5. Utility System Affected: ▫ Chilled Water ▫ Lighting ▫ Steam ▫ Dust Collection ▫ Purified Water ▫ Compressed Air ▫ Vacuum ▫ Potable Water ▫ Effluent ▫ Electrical ▫ Sprinkler System ▫ Sanitary Sewer ▫ Compressed Gas ▫ Other (list) 6. Heating, Ventilation and Air Conditioning (HVAC) Components Affected: ▫ Ductwork ▫ Room Pressure ▫ Insulation ▫ Diffusers/Grills ▫ Heat Exchange ▫ Humidification Unit N Coils ▫ Dehumidification ▫ Dampers ▫ Sensors ▫ Sequence of Operation ▫ Fans ▫ Pumps ▫ Air Handlers ▫ Room Air Changes ▫ Piping ▫ Other (list) 7. Architectural Systems/Components Affected: ▫ Walls ▫ Structural Members ▫ Ceilings ▫ Concrete ▫ Flooring ▫ Roofing ▫ Doors ▫ Windows ▫ Other (list) 8. Control and Software System Components Affected: ▫ PLC ▫ Hardware ▫ Software ▫ Other (list) 9. Environment, Health and Safety Systems Affected: ▫ Air Emissions ▫ Hot Work ▫ Electrical ▫ Waste Water ▫ Line Breaking ▫ Ladder Safety ▫ Waste ▫ Confined Space ▫ CFC ▫ Material Safety Data Sheet ▫ Other (list) 10 Documents Affected: ▫ SOPs/ Manuals (list)

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TABLE 5.1 How Good Validation Practices Address Common Facility Validation Problems Problem: Project Planning *HQHUDOO\SURMHFWWHDPVDUHXQGHUUHVRXUFHGIRUWKH VFRSHDQGGXUDWLRQRIDSURMHFW3URMHFWWHDPG\QDPLFV DUHQRUPDOO\LQHIÀFLHQWLIWKHLQGLYLGXDOWHDPPHPEHU UROHVDQGUHVSRQVLELOLWLHVDUHQRWFODULÀHG &RPSDUHGWRGLVFLSOLQHVOLNHFKHPLVWU\DQGHQJLQHHULQJ YDOLGDWLRQLVDUHODWLYHO\QHZWHFKQRORJ\DQGWKLVPHDQV WKDWPDQ\RIWKHSHRSOHLQNH\VHQLRUPDQDJHPHQW SRVLWLRQVWRGD\GRQRWIXOO\DSSUHFLDWHWKHH[WHQWDQG VFRSHRIYDOLGDWLRQWKHUHVRXUFHVUHTXLUHGDQGLWV EHQHÀFLDOFRQWULEXWLRQWRDSURMHFW7KLVPHDQVWKDW YDOLGDWLRQSURMHFWWHDPVDUHRIWHQXQGHUUHVRXUFHGIRU WKHVFRSHDQGGXUDWLRQRISURMHFWV .H\SHUVRQQHODUHRIWHQLQYROYHGWRRODWHLQWKHSURMHFW )RUH[DPSOHSURGXFWLRQWKRVHHQGXVHUVRIWKHIDFLOLW\ HQJLQHHULQJWKRVHUHVSRQVLEOHIRUPDLQWHQDQFHRID YDOLGDWHGIDFLOLW\DQGTXDOLW\DVVXUDQFH4$ WKRVH ZKRHQVXUHFOHDUXQGHUVWDQGLQJRIUHJXODWRU\ UHTXLUHPHQWVDQGSURFHGXUHVDQGSUDFWLFHVWREH HVWDEOLVKHGDQGLQFRUSRUDWHGXSIURQWLQWRWKHSURMHFW 7KHUHLVDOZD\VDWHQGHQF\WRDOORZSURMHFW´VFRSH FUHHSµZLWKDGGLWLRQDOGLUHFWLPSDFWV\VWHPVEHLQJ LGHQWLÀHGDQGLQVWDOOHGWKXVLQFUHDVLQJWKHYDOLGDWLRQ VFRSHZRUNORDGDQGUHVRXUFHUHTXLUHPHQWV)DFLOLW\ YDOLGDWLRQLVDOVRRIWHQH[WHQGHGWRLQFOXGHEXLOGLQJ V\VWHPVWKDWVKRXOGPRUHDSSURSULDWHO\EHLQFOXGHGDV SDUWRIWKHFRPPLVVLRQLQJHIIRUW &KDQJHFRQWURODQGPDQDJHPHQWV\VWHPVDUH QRWLPSOHPHQWHGDWWKHVWDUWRISURMHFWVRIWHQ UHVXOWLQJLQFRQIXVLRQPLVWDNHVDQGQHHGOHVVGHOD\V GXULQJFRQVWUXFWLRQ

Solution: Good Validation Practice Approach 6WHSVWUXFWXUHWKHSURMHFWWHDPDSSURSULDWHO\ DQGGHÀQHWKHLUIXQFWLRQVUROHVDQG UHVSRQVLELOLWLHV

Problem: Validation Planning 9DOLGDWLRQFRVWVKDYHLQFUHDVHGRYHUWKH\HDUVUHÁHFWLQJ KLJKHUVWDQGDUGVUHTXLUHGE\WKHUHJXODWRU\DXWKRULWLHV DQGDOVREHFDXVHLQGXVWU\KDVDGRSWHGLQHIÀFLHQWDQG FRVWO\EODQNHWYDOLGDWLRQFRPSOLDQFHVWUDWHJLHV7KLVLV EHFDXVHPRVWRUJDQL]DWLRQVODFNDFOHDUXQGHUVWDQGLQJ RIWKHUHDVRQIRUYDOLGDWLRQIDLOWRGHYHORSSURFHGXUHV WRDOORZWKHPWRFRQGXFWHIÀFLHQWYDOLGDWLRQDQGUDUHO\ DOORZWKHPVHOYHVVXIÀFLHQWWLPHDQGUHVRXUFHWRSODQ IRUYDOLGDWLRQDFWLYLWLHV

Solution: Good Validation Practice Approach 6WHSGHYHORSDUREXVW9036WHS VWDQGDUGL]HWKHYDOLGDWLRQDSSURDFKLQ YDOLGDWLRQ623VDQGHGXFDWH\RXUYDOLGDWRUV 6WHSFRQWLQXRXVO\LPSURYHDQGNHHS\RXU YDOLGDWLRQSUDFWLFHVFXUUHQWE\UHDSSO\LQJ OHVVRQVOHDUQHGIURPSUHYLRXVSURMHFWV

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TABLE 5.1 (continued) How Good Validation Practices Address Common Facility Validation Problems )DVWWUDFNSURMHFWVRIWHQPHDQWKDWYDOLGDWLRQHIIRUWV EHJLQDIWHUWKHGHWDLOHGGHVLJQLVFRPSOHWHDQGWKH SURMHFWLVQHDULQJWKHFRQVWUXFWLRQSKDVH,QVXIÀFLHQW WLPHLVWKHQDOORFDWHGWRYDOLGDWLRQLQWKHRYHUDOOSURMHFW SODQOHDYLQJLQVXIÀFLHQWWLPHIRUFRUUHFWLYHDFWLRQ ZKHQDV\VWHPRUHTXLSPHQWIDLOVYDOLGDWLRQWHVWV7KLV SXWVHQRUPRXVSUHVVXUHRQWKHYDOLGDWLRQWHDPWR FRPSOHWHWKHLUDFWLYLWLHV &RPPLVVLRQLQJDQGYDOLGDWLRQPDVWHUSODQV903V DUH RIWHQUXVKHGDQGSRRUO\FRQVWUXFWHGDQGWKHFRQWHQW DQGSUHVHQWDWLRQRIGRFXPHQWDWLRQDUHIUHTXHQWO\ LQDGHTXDWH903VDUHRIWHQQRWZULWWHQHDUO\HQRXJK LQWKHSURMHFWDQGLQVXIÀFLHQWGHWDLOWRLGHQWLI\ LPSRUWDQWUHVRXUFHSODQQLQJDQGWLPHOLQHFRQVWUDLQWV WKDWFDQLPSDFWWKHYDOLGDWLRQWHDP·VSHUIRUPDQFH $QRWKHURQHRIWKHPDMRUUHDVRQVIRUWKLVFRQWLQXLQJ GLIÀFXOW\LQWKHDSSOLFDWLRQRIDQGFRPSOLDQFHZLWK WKHYDOLGDWLRQFRQFHSWVKDVEHHQWKHUDSLGWHFKQRORJLFDO DGYDQFHPHQWRIWKHSKDUPDFHXWLFDOLQGXVWU\ $GYDQFLQJPDQXIDFWXULQJWHFKQRORJ\PDNHVQHZ IDFLOLWLHVLQFUHDVLQJO\PRUHFRPSOH[DQGEULQJVKLJKHU H[SHFWDWLRQVIRURXWSXWTXDOLW\DQGHIÀFLHQF\+HUH IHDUVRISODQWVKXWGRZQVDQGSRVVLEOHÀQDQFLDOORVVHV DUHIRUFLQJYDOLGDWLRQWHDPVWRTXDOLI\RUYDOLGDWH QRQFULWLFDOF*03V\VWHPVWKDWUHDOO\RQO\UHTXLUH FRPPLVVLRQLQJ $VYDOLGDWLRQSHUVRQQHOZHUHQRWWUDLQHGHDUO\RQLQWKH SURMHFWLQWKHRSHUDWLRQDQGXVHRIQHZV\VWHPVDQG HTXLSPHQWPRVWSURWRFROVZHUHZULWWHQLQLWLDOO\EDVHG RQWKHLQLWLDOSURMHFWGHVLJQGRFXPHQWDWLRQ7KHVH SURWRFROVZHUHWKHQUHZRUNHGDIWHUFRPPLVVLRQLQJDQG VWDUWXSWRUHÁHFWWKHDVEXLOWGHVLJQFRQGLWLRQV7KLV ZDVDQLQHIÀFLHQWDQGWLPHFRQVXPLQJDSSURDFKWR SURWRFROGHYHORSPHQW 9HQGRUVDUHQRWIXOO\LQIRUPHGXSIURQWRIWKH LPSRUWDQFHRIF*03DQGYDOLGDWLRQGRFXPHQWDWLRQ DQGWKLVUHVXOWVLQWKHODWHGHOLYHU\RIGRFXPHQWDWLRQ WRWKHYDOLGDWLRQWHDP7KLVOHDGVWRWKHLQHIÀFLHQW ZULWLQJDQGH[HFXWLRQRISURWRFROVDQGRIWHQUHVXOWVLQ DIUXVWUDWLQJGRFXPHQWDWLRQFKDVHZDVWLQJSUHFLRXV YDOLGDWLRQWLPHDQGUHVRXUFHVZKHQWKH\DUHPRVW LQGHPDQG

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TABLE 5.1 (continued) How Good Validation Practices Address Common Facility Validation Problems Problem: Commissioning 3URMHFWV\VWHPDQGHTXLSPHQWFRPPLVVLRQLQJDFWLYLWLHV DUHRIWHQQRWSODQQHGVXIÀ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

&RPPLVVLRQLQJDQGYDOLGDWLRQWHVWLQJDFWLYLWLHVDUHRIWHQ GXSOLFDWHGGXULQJSURMHFWV

Problem: Qualiﬁcation and Validation &RPPLVVLRQLQJDQGYDOLGDWLRQWHVWLQJFDQRIWHQEH XQQHFHVVDULO\GXSOLFDWHGGXULQJDSURMHFW 2IWHQSURWRFROVDUHZULWWHQLQLWLDOO\EDVHGRQWKHLQLWLDO SURMHFWGHVLJQGRFXPHQWDWLRQDQGLQLVRODWLRQRIWKH DFWXDOGHVLJQDQGFRQVWUXFWLRQ7KHVHSURWRFROVDUH WKHQUHZRUNHGDIWHUFRPPLVVLRQLQJDQGVWDUWXSWR UHÁHFWWKHDVEXLOWGHVLJQFRQGLWLRQV7KLVLVDQ LQHIÀFLHQWDQGWLPHFRQVXPLQJDSSURDFKWRSURWRFRO GHYHORSPHQW 7KHVHWWLQJRIXQFOHDUTXDOLW\DFFHSWDQFHFULWHULDIRUWKH YDOLGDWLRQFDQOHDGWRXQQHFHVVDU\H[WUDZRUNH[WUD FRVWDQGFRPSOLFDWLRQVGXULQJWKHYDOLGDWLRQSURJUDP

© 2004 by CRC Press LLC

Solution: Good Validation Practice Approach 6WHSDGRSWIRUPDOFRPPLVVLRQLQJ SURFHGXUHV6WHSDYRLGGXSOLFDWHWHVWLQJ³ LQWHJUDWHFRPPLVVLRQLQJZLWKYDOLGDWLRQ DFWLYLWLHV6WHSIRUPDOL]HWKHSURMHFWWXUQ RYHUSURFHVVDQGWXUQRYHUGRFXPHQWDWLRQ SDFNDJHUHTXLUHPHQWV

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TABLE 5.1 (continued) How Good Validation Practices Address Common Facility Validation Problems $YDOLGDWLRQHIIRUWFDQLQFOXGHWKHYHULÀFDWLRQRIUHODWHG SURJUDPVIRUH[DPSOHHQYLURQPHQWDOKHDOWKDQG VDIHW\DVVHVVPHQWVHOHFWULFDOLQVWDOODWLRQ623V WUDLQLQJDQGSUHYHQWDWLYHPDLQWHQDQFHDQGFDOLEUDWLRQ VFKHGXOHYHULÀFDWLRQV(YHQWKRXJKWKHVHDUH XQGHUWDNHQDVSDUWRIWKHIDFLOLW\SURMHFWDQGPD\ SURYLGHDVVLVWDQFHDQGLQIRUPDWLRQLQVXSSRUWRIWKH TXDOLÀFDWLRQDFWLYLWLHVWKHVHUHODWHGDFWLYLWLHVFDQRIWHQ GHOD\WKHFORVXUHDQGDSSURYDORIWKHH[HFXWHG YDOLGDWLRQSURWRFROV 7KHPRVWFRPPRQSUREOHPVIRXQGGXULQJUHJXODWRU\ *03IDFLOLW\DXGLWVDUHLQDGHTXDWHGRFXPHQWDWLRQRU IDLOXUHWRIROORZDSSURYHGSURFHGXUHVDQGSURWRFROV DQGQRWGXHWRGHVLJQGHÀFLHQFLHV

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Problem: Plant Start-Up 623VGHWDLOLQJWKHRSHUDWLRQPDLQWHQDQFHDQG FDOLEUDWLRQRIHTXLSPHQWDVZHOODV623VIRUIDFLOLW\ DQGHTXLSPHQWFOHDQLQJDUHRIWHQHVWDEOLVKHGWRRODWH LQWKHSURMHFWOLIHF\FOH7KLVWRJHWKHUZLWKSURMHFW PLOHVWRQHVEHLQJRYHUUXQRIWHQGRHVQRWSURYLGH VXIÀFLHQWWLPHIRUWUDLQLQJ )RUPDO4$FKDQJHFRQWURODQGPDQDJHPHQWV\VWHPV DUHRIWHQQRWLPSOHPHQWHGRUIROORZHGDWSODQW VWDUWXSRIWHQUHVXOWLQJLQWKHQXOOLÀFDWLRQRIWKH YDOLGDWLRQH[HUFLVH

Solution: Good Validation Practice Approach 6WHSVWDUWIDFLOLW\UHODWHGFRPSOLDQFH SURJUDPVHDUOLHULQWKHSURMHFW

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Project Concept Phase

1. 2. 3. 4.

Project Definition Phase

Design & Procurement Phase Construction & Installation

Structure the project team Get the project team to buy in Define the validation scope Develop a robust VMP

5. 6. 7.

Conduct quality compliance audits Give the vendors the information Integrate validation schedules

8. 9. 10. 11.

Involve QA throughout the project Encourage stakeholder participation Standardize the validation approach Educate the project team

12. 13. 14. 15.

Start compliance programs early Enhance the documentation Conduct periodic audits Formalize the project turn-over process

16. 17. 18. 19. 20.

Formalize commissioning Integrating commissioning & validation Hand-over and train the users Have a revalidation strategy Keep validation practices current

FIGURE 5.1 7KHYDOLGDWLRQFRQWLQXRXVLPSURYHPHQWPRGHO © 2004 by CRC Press LLC

Commissioning & Validation

Validation Time/Cost (%)

60 50% 50 40 30% 30 20

15%

10

5%

0 Collect and review technical documents

Write protocol

Execute protocol in the field

Analyze data and write final report

Activity

FIGURE 5.2 &RPPRQFRPSRQHQWFRVWVRIYDOLGDWLRQ

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