Facility Validation - Theory, Practice, and Tools (PDFDrive)

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
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International Standard Book Number 0-8493-2340-1
Library of Congress Card Number 2003065586
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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 manu-
facturing to continuously improve over time. This is forcing companies to evaluate
their validation programs to investigate ways of streamlining the process of valida-
tion. 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 pharmaceu-
tical 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 engineer-
ing 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.

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 cGMP-
compliant 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.

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 manufactur-
ing, 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.

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 facili-
ties 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 inef-
ficient 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,

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 docu-
mentary 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 qualifica-
tion (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 pro-
cedures 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 manage-
ment 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.

• 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 manufactur-
ing 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 Pharma-

ceutical 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

• 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 opportuni-
ties 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 cGMP-
compliant 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.

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
1.2 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 Validation Concepts, Definitions, and Terminology
2.2 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 The Practice of Facility Validation

3.1 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)

3.1.6 Commissioning
3.1.7 Installation and Operational Qualification (IQ/OQ)
3.1.8 Performance Qualification (PQ)
3.1.9 Related Compliance Programs
3.1.10 Plant Release and Start-Up
3.1.11 Periodic Review, Change Control, and Revalidation
References
Chapter 4 Twenty Tools Recommended for Facility Validation

4.1 Common Problems Associated with Facility Validation
4.2 Good Validation Practice
4.3 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

Chapter 5 Good Validation Practices
5.1 Benefits of Following Good Validation Practices
5.2 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

1 The Regulatory
Requirements for
Validation in the
Pharmaceutical Industry
1.1 THE REGULATORY REQUIREMENTS OF
GOOD MANUFACTURING PRACTICE (GMP)
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TABLE 2.2
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TABLE 4.1
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Environment, Health & Safety Validation

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Business Technology Analytical Technology

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Project Name: Sub-Team Strategy Document
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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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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. Description of the system operation and control

2. Verification that the duct material and construction is in accordance with SABS 1022 and SABS 1238-
1979 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 0173-
1980 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
FIGURE 4.4 'RFXPHQWDWLRQUHTXLUHPHQWVIRU+9$&YHQGRUV

TABLE 4.3
List of Critical Documents Required for Validation
Document Category Required for
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4.10 STEP 8: DEFINE VALIDATION SCOPE; CONDUCT

IMPACT ANALYSIS EARLY
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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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TABLE 4.4
System/Component Impact Analysis Decisions
System/Component Product Impact Evaluation Decision
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TABLE 4.5
Validation Master Plan Matrix of Systems Subject to GEP
or Validation
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4.12 STEP 10: INTEGRATE VALIDATION SCHEDULES

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TABLE 4.6
Sample Components of the Validation Master Plan
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TABLE 4.6 (continued)
Sample Components of the Validation Master Plan
Section Content
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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 Relocation, installation and requalification of granulation processing
equipment in the upgraded Tablet Granulation facility on a phased
basis.
Project timelines Tentative dates: 1st until 22 nd December. Timelines to be further
negotiated with Production and Planning.
Project resources 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.
Validation scope 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.
Equipment 1 Retrofit expected to be completed by mid November – can be installed
and requalified if AHU has been installed.
Equipment 2 Can be installed and qualified beginning of November.
Equipment 3 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.
Equipment 4 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.
Equipment 5 Safety proximity switch/interlock to be decided on.
Equipment 6 Expected to be completed by end November – can be installed and
qualified.
Equipment 7 Qualification to start end October.
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Task Name Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb
Project Planning
Validation Planning
Design Phase
Request for Quotation
Procurement Phase
Construction Phase
Commissioning
Documentation Preparation
Protocol Development
Validation IQ/OQ
Validation PQ
Training
Validation Approval
Project Completion
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4.13 STEP 11: ADOPT FORMAL COMMISSIONING
PROCEDURES
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TABLE 4.7
Typical Commissioning Deliverables
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TABLE 4.8
HVAC Commissioning Report Example
Air Flow Direction in Accordance with HVAC Design (Y/N)
Design and Measured Air Quantities: Supply Air
Upper Measured
Design Air Limit Lower Limit Capacity Pass or
Room Location# Qty m3/s m3/s m3/s m3/s Fail
Air Change Rates1
Air Flow Room Air Air Flow Air Pass or

Room m3/s Vol/m3 Change/h m3/s Change/h Fail
Room Pressures
Design Design Measured

Condition Condition Upper Condition Pass or
Room (Relative) (Absolute) Limit Lower Limit (Relative) Fail
Room Temperature and Humidity (Relative and Absolute)
Measured Measured
Design Upper Lower Condition Condition Pass or
Room Condition Limit Limit (Maximum) (Minimum) Fail
Dust Extraction
Upper Measured
Service Design Air Limit Lower Limit Capacity Pass or
Room Panel # Flow m3/s m3/s m3/s m3/s Fail
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TABLE 4.9
Typical Equipment Qualification SOP Contents
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1.0 DOCUMENT APPROVAL
2.0 INTRODUCTION
2.1 Objective
2.2 Rationale
2.3 Scope
2.4 Exclusions and Assumptions
2.5 Handling Deviations and Corrective Actions
2.6 Equipment Description
3.0 RESPONSIBILITIES
4.0 QUALIFICATION TEST PLAN
4.1 Installation Qualification (IQ)
4.1.1 Purpose
4.1.2 Installation Verification
4.1.3 Qualification Data Sheets
4.1.3.1 Equipment Summary Information
4.1.3.2 Equipment Component Verification
4.1.3.3 Identification of Equipment Controls, Indicators, and Instruments
4.1.3.4 Compressed Air Installation
4.1.3.5 Electrical Installation
4.1.3.6 Filter Information
4.1.3.7 Materials of Construction
4.1.3.8 Calibration Information
4.1.3.9 Maintenance Requirements
4.1.3.10 Equipment Manuals
4.1.3.11 Equipment Drawings
4.1.3.12 Safety Assessment
4.2 Operational Qualification (OQ)
4.2.1 Purpose
4.2.2 OQ Test
4.2.3 Standard Operating Procedures and Training
4.3 Performance Qualification (PQ)
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5.0 TEST INSTRUMENTATION
6.0 SUMMARY OF DEVIATIONS
7.0 DISCUSSION AND CONCLUSIONS
8.0 FINAL PROTOCOL APPROVAL FORM
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4.15 STEP 13: AVOID DUPLICATE TESTING; INTEGRATE

COMMISSIONING WITH VALIDATION ACTIVITIES
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1.0 DOCUMENT APPROVAL
2.0 INTRODUCTION
2.1 Objective
2.2 Scope
2.3 Exclusions and Assumptions
2.4 Deviations and Corrective Actions
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3.0 RESPONSIBILITIES
4.0 QUALIFICATION DATA SHEETS
5.1 Installation Verification
5.1.1 Installation/Operational Documentation Verification
5.1.2 Design Specifications
5.1.3 As-Built Drawings
5.1.4 Equipment Identification
5.1.5 Materials of Construction
5.1.6 Mechanical Installation
5.1.7 Filter Installation
5.1.8 Chilled Water Installation Verification
5.1.9 Electrical Installation
5.1.10 Identification of Controls, Indicators and Instrumentation
5.1.11 HEPA Filter Integrity Test Reports
5.1.12 Safety Inspection Report
5.1.13 Preventative Maintenance and Calibration Program
5.1.14 Calibration Certificates
5.2 Operational Verification
5.2.1 Controls Operation
5.2.2 AHU Operating Parameter Control
5.2.3 Room Temperature and Relative Humidity
5.2.4 Room Pressurization
5.2.5 Air Change Rates
5.2.6 Air Particle Counts
5.2.7 Viable Air Sampling (Environmental Monitoring)
5.2.8 SOPs and Training
6.0 TEST INSTRUMENTATION
7.0 SUMMARY OF DEVIATIONS
8.0 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 Validation Phase
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TABLE 4.11
Factory Acceptance Testing Conducted at FBD Vendor Facility
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TESTS (SAT) FACILITY/EQUIPMENT
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TESTING INSPECTION (PDI)
FACTORY ACCEPTANCE
TESTS (FAT)
USER REQUIREMENTS
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DESIGN SPECIFICATIONS
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TABLE 4.12
An Example of a Validation Turn-Over Form
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(%) Project Name Project Description Category Due Date Completed
100 Product 1 Process Validation Process May 2003
80 Product 2 Process Validation Process June 2003
100 Equipment 1 Equipment IQ/OQ/PQ Equipment May 2003
75 Equipment 2 Equipment IQ/OQ/PQ Equipment July 2003
100 Facility 1 Facility IQ Facility May 2003
50 Facility 2 Facility IQ Facility July 2003
100 Utility 1 Utility IQ/OQ Utility May 2003
65 Utility 2 Utility IQ/OQ Utility August 2003
80 Computer System 1 Computer Validation Computer August 2003
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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
Equipment 3 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
Lifting Columns 1. Load test certification required
2. Jaws to be modified
Equipment 4 1. Magnehelic gauges over the filters require labeling for identification
of operating pressures and filter change pressures.
2. SOP for operation written
Equipment 5 Electrical compliance certificate required
Equipment 6 1. SOP draft for cleaning written
General 1. Quality testing of compressed air to be scheduled in May
2. Compressed air and steam drawings to be red-lined or updated
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4.21 STEP 19: DEVELOP A REVALIDATION STRATEGY TO

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EQUIPMENT / UTILITY / FACILITY CHANGE REQUEST
Change Request No.:

Equipment/Utility/Facility Change: (Mark appropriate box with an X)
Originating Department:
Asset No:
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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Project Concept Phase Project Definition Phase Design & Procurement Phase Construction & Installation Commissioning & Validation
1. Structure the project team

2. Get the project team to buy in
3. Define the validation scope
4. Develop a robust VMP
5. Conduct quality compliance audits

6. Give the vendors the information
7. Integrate validation schedules
8. Involve QA throughout the project

9. Encourage stakeholder participation
10. Standardize the validation approach
11. Educate the project team
12. Start compliance programs early

13. Enhance the documentation
14. Conduct periodic audits
15. Formalize the project turn-over process
16. Formalize commissioning

17. Integrating commissioning & validation
18. Hand-over and train the users
19. Have a revalidation strategy
20. Keep validation practices current
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Collect and Write protocol Execute Analyze data
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7 Glossary of Definitions
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Facility Validation - Theory, Practice, and Tools (PDFDrive)

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Facility Validation - Theory, Practice, and Tools (PDFDrive)

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FACILITY

Visit the CRC Press Web site at www.crcpress.com

© 2004 by CRC Press LLC

No claim to original U.S. Government works

© 2004 by CRC Press LLC

© 2004 by CRC Press LLC

© 2004 by CRC Press LLC

© 2004 by CRC Press LLC

• The premises, facilities, and equipment have been designed in accordance

• Validation activities form a significant percentage of time and money

© 2004 by CRC Press LLC

Pharmaceutical industries, regulatory authorities, institutions, and corporations

• Chapter 1: The Regulatory Requirements for Validation in the Pharma-

© 2004 by CRC Press LLC

• Practical approaches that may be used for integrating the commissioning

© 2004 by CRC Press LLC

Chapter 2 The Fundamentals and Essentials of Validation

Chapter 3 The Practice of Facility Validation

© 2004 by CRC Press LLC

Chapter 4 Twenty Tools Recommended for Facility Validation

© 2004 by CRC Press LLC

Chapter 6 Conclusions and Future Directions

Chapter 7 Glossary of Definitions and Terms Associated with Validation

© 2004 by CRC Press LLC

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1.1.1 BUILDINGS AND FACILITIES

© 2004 by CRC Press LLC

1.1.1.1 GMP Principles

© 2004 by CRC Press LLC

© 2004 by CRC Press LLC

© 2004 by CRC Press LLC

1.1.2.1 GMP Principles

© 2004 by CRC Press LLC

1.2 THE RELATIONSHIP BETWEEN VALIDATION AND GMP

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1.2.2 QUALITY ASSURANCE

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1.3 THE IMPACT OF CHANGING REGULATIONS ON

1.4 THE FUTURE OF GMP

© 2004 by CRC Press LLC

© 2004 by CRC Press LLC

© 2004 by CRC Press LLC

© 2004 by CRC Press LLC

2.2 THE PHILOSOPHY AND KEY PRINCIPLES OF

2.2.1 THE LIFE-CYCLE APPROACH TO VALIDATION

© 2004 by CRC Press LLC

2.2.2 QUALIFICATION PRACTICES

© 2004 by CRC Press LLC

User Requirements Use

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2.3 ORGANIZING AND PLANNING FOR VALIDATION

2.3.1 ORGANIZING FOR VALIDATION

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