VALIDATION BOOT CAMP

LIFECYCLE APPROACH TO
PHARMACEUTICAL VALIDATION –
PRINCIPLES, IMPLEMENTATION, AND PRACTICE

Paul L. Pluta, PhD

Journal of Validation Technology
Journal of GXP Compliance
University of Illinois at Chicago (UIC) College of Pharmacy
Chicago, IL, USA

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 OUTLINE
• Process Validation Lifecycle Approach Overview
• FDA PV Guidance
• Documentation
• Lifecycle Approach to Cleaning Process Validation
• Lifecycle Approach to Equipment Qualification
• Lifecycle Approach to Validation Quality System
• Implementation Strategy
• Interactive Discussion. Attendees discuss lifecycle
approach to process, other applications, positives/
negatives, and impediments to implementation
throughout day.
PLEASE PARTICIPATE
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 OBJECTIVES
• Validation lifecycle approach basic understanding
– Terminology
– Validation and qualification
– History and basis
– Stages and activities
• Documentation for lifecycle approach
– Comprehensive
– New specific expectations
• Applications according to lifecycle approach
– Processes, Cleaning, EFU
– Validation quality system
– Other quality systems
• Implementation strategy

QUESTIONS:
DOES THIS MAKE SENSE?
HOW DO YOU APPROACH VALIDATION?

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 SCHEDULE
8:15 Registration, welcome and opening remarks

8:30 Part I. Introduction, basis, lifecycle stages

10:00 Break – Specific requests / clarifications

10:30 Part II. Documentation

11:50 Morning assessment
12:00 Lunch – Specific requests / clarifications

1:00 Part III. Applications -- Cleaning, EFU, Quality Systems

2:30 Break – Specific requests / clarifications

3:00 Part IV -- Implementation

3:20 Loose ends, Final Q&A, etc.
3:45 Summary
4:00 End
COMMENTS AND QUESTIONS ANY TIME
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 FILES
#1. Overview and history
#2. Documentation
#3. Cleaning
#4. Equipment
#5. Validation Quality System
#6. Implementation

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 INTRODUCTION, BASIS, LIFECYCLE STAGES

• History and Development

• Fundamental Concepts
• Consistency with Medical Devices

IS THE LIFECYCLE APPROACH REALLY NEW?

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 PROCESS VALIDATION LIFECYCLE APPROACH
OVERVIEW
2004 – Health Canada guidance
2005 – FDA initial presentations
2007 – ICH Q10
2008 – FDA draft guidance
2009 – ICH Q8(R2)
2009 – Health Canada revision
2011 – FDA guidance issued
2012 – EMA draft guidance

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 HISTORY AND DEVELOPMENT –
LIFECYCLE APPROACH

PROCESS VALIDATION LIFECYCLE APPROACH

IS IT REALLY NEW?

Health Canada introduces lifecycle phases in 2004.

FDA lifecycle approach (stages) to process validation
incorporated concepts of ICH Q8, Q9, Q10, QbD, and
PAT – presentations starting 2005.
Many concepts previously mentioned in documents issued
before 2000.

See slides 8-42.

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 HEALTH CANADA -- VALIDATION GUIDELINES FOR
PHARMACEUTICAL DOSAGE FORMS (GUI-0029)

5.0 Phases of Validation

Phase 1: Pre-Validation Phase
Phase 2: Process Validation Phase (Process Qualification Phase
Phase 3: Validation Maintenance Phase

6.0 Interpretation
Validation protocol
Validation Master Plan
Installation and Operational Qualification
IQ
OQ
Re-Qualification
Process validation
Prospective validation
Matrix or family approaches to prospective process validation
Concurrent validation
Retrospective validation
Process Re-Validation
Change control
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 ICH Q8 (R2) PHARMACEUTICAL DEVELOPMENT

Objectives
Harmonized regulatory submissions (CTD)
Principles of Quality by Design (QbD)
Consistent with Q9 Risk Management

Problems addressed
Inconsistency between all regions
Inconsistent content
Inclusion of development information

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 ICH Q8 PHARMACEUTICAL DEVELOPMENT

Drug product development considerations

Components: API and excipients
Formulation development
Overages
Physicochemical and biological properties
Manufacturing process development
Container-closure systems
Microbiological attributes
Compatibility

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 ICH Q8 PHARMACEUTICAL DEVELOPMENT
Key points
“Information and knowledge gained from development
studies and manufacturing experience provides scientific
understanding to support the establishment of the design
space, specifications, and manufacturing controls.”
“Pharmaceutical development section should describe the
knowledge…”
“At a minimum, those aspects of drug substances,
excipients, … that are critical to product quality should be
determined and control strategies justified.”
“…demonstrate a higher degree of understanding of
material attributes, manufacturing processes …”

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 ICH Q8 PHARMACEUTICAL DEVELOPMENT

Key points
Examination
Understanding
Evaluation
Identification
Rationale and justification
Others

Discussion in submission

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 ICH Q8 PHARMACEUTICAL DEVELOPMENT

Implications for Process Validation

Process understanding
Process development studies are basis for
process validation
Continuous process verification is
alternate to process validation

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 ICH Q9 QUALITY RISK MANAGEMENT
Objectives:
• Effective application of risk management
• Consistent science-based decisions
Incorporate risk management into practice
Problems addressed:
• Inconsistent risk-management application
• Common understanding

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 ICH Q9 QUALITY RISK MANAGEMENT

Principles of quality risk management

• General process: Initiation, assessment, control,
communication, review
• Methodology
• Integration into industry and regulatory
operations
• Methods and tools
• Potential specific applications

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 ICH Q9 QUALITY RISK MANAGEMENT
• Initiate risk management process
• Risk assessment
• Risk identification
• Risk analysis
• Risk evaluation
• Risk control
• Risk reduction
• Risk acceptance
• Output
• Risk review

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 ICH Q9 QUALITY RISK MANAGEMENT
Risk Management Methods and Tools
• Basic methods: Flow charts, process maps, cause and
effect (fishbone) diagrams
• FMEA / FMECA
• FTA
• HAACP
• HAZOP
• PHA
• Risk ranking and filtering

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 ICH Q9 QUALITY RISK MANAGEMENT
Applications
• Integrated quality management: Documentation,
training, defects, auditing, periodic review, change
control, improvements
• Regulatory operations
• Development: Process knowledge, PAT development
• Facilities, equipment, utilities: Design, qualification,
cleaning, calibration, PM
• Materials management: Material variation
• Production: Validation, in-process testing
• Laboratory control and stability
• Packaging and labeling
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 ICH Q9 QUALITY RISK MANAGEMENT

Key points
• Methods of evaluation
• Potential applications – every function, every
activity, entire product lifecycle

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 ICH Q9 QUALITY RISK MANAGEMENT

Implications for Process Validation

• Development: Process knowledge
• Materials: Variation, change control
• Equipment: Qualification, cleaning, calibration,
PM, change control
• Production: Validation, sampling, testing,
change control
• Maintenance / monitoring: Testing

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 ICH Q10
PHARMACEUTICAL QUALITY SYSTEMS
Objectives
• Global harmonization of quality systems
• Consistency with ICH Q8 and Q9
• Application throughout product lifecycle

Problems addressed
• Inconsistent application
• Inconsistent definitions of common terms

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 ICH Q10
PHARMACEUTICAL QUALITY SYSTEMS

Overview and definitions

Management responsibility: Commitment,
policy, planning, resources, communication,
review, outsourcing
Continual improvement of performance and
quality: Lifecycle stages and elements
Continual improvement of quality system:
Management, monitoring, outcomes

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 ICH Q10
PHARMACEUTICAL QUALITY SYSTEMS

Key points:
• Quality system application throughout product lifecycle
• Pharmaceutical development
• Technology transfer
• Manufacturing
• Product discontinuation
• Product realization, maintain control, improvements
• Enable by knowledge and risk management
• Management responsibility: Commitment, policy,
planning, resources, communication, review, outsourcing
oversight
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 ICH Q10
PHARMACEUTICAL QUALITY SYSTEMS
Key points:
• Continual improvement
• Product performance / quality monitoring system
• Control strategy, identify variation, problem feedback,
enhance process understanding
• CAPA system
• Enhance process understanding
• Change management system
• Risk management, evaluation, technical justification
• Management review
• Audits, inspections, changes, CAPA, etc.

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 ICH Q10
PHARMACEUTICAL QUALITY SYSTEMS

Implications for Process Validation

• Product performance and monitoring
• CAPA system enhances process understanding
• Change management system
• Process improvements

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 ICH Q11
DEVELOMENT AND MANUFACTURE
OF DRUG SUBSTANCES

Consistent with ICH Q8, Q9, and Q10

Lifecycle approach
CQA, CPP
Design space
Control of variables
Process validation
Risk management

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 QUALITY BY DESIGN (QbD)
Quality target product profile (QTTP)
Critical quality attributes (CQA), critical material attributes
(CMA)
Critical process parameters (CPP)
Design space
Scale-up and technology transfer
Identify input variables
Input variable control strategy
Continuous improvement
Other considerations: PAT, risk analysis

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 SUPPORTING DOCUMENTS
PROCESS VALIDATION – 1987 GUIDANCE
Assurance of product quality:
Quality parts and materials
Adequate product and process design
Control of the process
In-Process and end-product testing.
Basic principles:
Quality, safety, and effectiveness designed and built into the product
Quality cannot be inspected or tested in the product
Each process step must be controlled to maximize meeting quality and design
specifications.
R&D phase: Product definition and characteristics
Equipment and process
Equipment: Installation Qualification
Process: Performance Qualification
Product (devices only): Performance Qualification
Revalidation. Change control
Documentation. Proper maintenance of documentation

Reference: FDA Guideline on General Principles of Process Validation. May, 1987

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 VALIDATION – PHARMACEUTICAL DOSAGE FORMS
FDA INSPECTION GUIDELINES
Three phases of the validation process:
• Product development
• Design of the validation protocol
• Demonstration runs (validation) – full scale
Process validation
Documented evidence
• Consistency
• Predetermined specifications
Documented evidence includes experiments, data, and results
Product Development Reports
Control of the physical characteristics of the excipients
Particle size testing of multi-source excipients
Critical process parameters
Development data serves as the foundation for the manufacturing procedure
Variables are identified in the development phase
Raw materials may vary lot-to-lot
References: FDA Guides to Inspections. Oral Solid Dosage Forms (January 1994), Topical Drug
Products (July 1994), Oral Solutions and Suspensions (August 1994)

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 SUPPORTING DOCUMENTS
VALIDATION – MEDICAL DEVICES
Planning the Process Validation Study
Installation and Operational Qualification
Process Performance Qualification
Eliminate controllable causes of variation
Product Performance Qualification
Evaluate routine production process monitoring data for trends

Process operating in a state of control is determined by analyzing

day-to-day process control data and finished device test data
for conformance with specifications and for variability.

Reference: FDA Medical Device Quality Systems Manual. January

07, 1997

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 SUPPORTING DOCUMENTS
PROCESS VALIDATION – API
Critical parameters / attributes identified during
development
Qualification of equipment and systems: DQ, IQ, OQ, PQ.
Process Validation Program
Critical process parameters controlled and monitored
Non-critical parameters not included in validation
Periodic review of validated systems

Reference: ICH Q7. Good Manufacturing Practice Guide

for Active Pharmaceutical Ingredients. November, 2000.

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 SUPPORTING DOCUMENTS
PROCESS VALIDATION – PRODUCTS / API
A validated manufacturing process has a high level of
scientific assurance that it will reliably product acceptable
product.

Proof of validation is obtained through rational experimental

design and the ongoing evaluation of data, preferably
beginning from the process development phase continuing
through the commercial production phase.

Reference: FDA Section 490.199. CPG 7132c.08.

Process Validation Requirements for Drug Products and
Active Pharmaceutical Ingredients Subject to Pre-Market
Approval. 2004 revision.
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 SUPPORTING DOCUMENTS
PROCESS VALIDATION – PRODUCTS / API
Before commercial distribution:
Product and process development
Scale-up studies
Equipment and system qualification
Conformance batches
Identify and control all critical sources of variability
Advance manufacturing control technology may
eliminate validation lots.
Reference: FDA Section 490.199. CPG 7132c.08.
Process Validation Requirements for Drug Products and
Active Pharmaceutical Ingredients Subject to Pre-Market
Approval. 2004 revision.

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 SUPPORTING DOCUMENTS
VALIDATION -- PHARMACEUTICAL CGMPS

Cross-Agency workgroup CDER, CBER, ORA, and CVM.

“The CPG clearly signals that a focus on three full-scale

production batches would fail to recognize the complete
story on validation.”

Reference: FDA. Pharmaceutical CGMPs for the 21st

Century – A Risk-Based Approach. Final Report,
September 2004.

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 SUPPORTING DOCUMENTS
PROCESS VALIDATION – MEDICAL DEVICES
Process evaluation – Validation or verification
Protocol development
Processes well thought out
What could go wrong
Installation Qualification
Operational Qualification
“Worst case” testing
DOE and screening studies
Performance Qualification
Process repeatability
Attributes for continuous post-validation monitoring and maintenance
Eliminate controllable causes of variation.
Maintaining a state of validation – Monitor and control
Change control
Statistical Methods
Risk Analysis Methods
Reference: Global Harmonization Task Force (GHTF) Study Group 3. Quality

Management Systems – Process Validation Guidance. January 2004.

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 SUPPORTING DOCUMENTS
VALIDATION – INTERNATIONAL
PIC/S PHARMACEUTICAL INSPECTION CONVENTION

A series of experiments should be devised to determine the

criticality of process parameters / factors

Test processes with starting materials on the extremes of

specification

Monitoring and in-process controls

Reference: PIC/S Recommendations on Validation. July

2004.

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 SUPPORTING DOCUMENTS
FDA -- QUALITY BY DESIGN (QbD)
Product is designed to meet patient requirements
Process is designed to consistently meet product critical
quality attributes
Impact of starting materials and process parameters on
product quality is understood
Critical sources of process variability are identified and
controlled
Process is continually monitored and updated to assure
consistent quality over time

Reference: FDA. Chi-wan Chen, ISPE, Japan, June,

2006

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 SUPPORTING DOCUMENTS
PROCESS ROBUSTNESS (PQRI)
Robust Process: Able to tolerate expected variability of
raw materials, operating conditions, process equipment,
environmental conditions, and human factors
Development
Maintenance
Process understanding is key to developing a robust
process.

Reference: Product Quality Research Institute (PQRI).

Pharmaceutical Engineering, November-December, 2006

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 SUPPORTING DOCUMENTS
ASTM WK 9935 Standard Guide
Continuous Quality Verification (CQV)
A Science and Risk-Based Alternative Approach to
Traditional Process Validation of Biopharmaceutical
and Pharmaceutical Manufacturing Processes
CONTINUOUS QUALITY VERIFICATION
Process design / Risk assessment / Process
understanding
Development phase
Scale-up phase
Commercialization phase
Process capability evaluation
Continuous process improvement

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 SUPPORTING DOCUMENTS
PROCESS ANALYTICAL TECHNOLOGY (PAT)

Processes verified by PAT are not validated

All associated PAT equipment and analytical methods are

validated

Reference: FDA. PAT -- A Framework for Innovative

Pharmaceutical Development, Manufacturing, and Quality
Assurance. September 2004

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 SUPPORTING DOCUMENTS
PROCESS ANALYTICAL TECHNOLOGY (PAT)
Process Understanding
All critical sources of variability are identified and explained.
Variability is managed by the process
Product quality attributes can be accurately and reliably predicted
over the design space
Materials used
Process parameters
Manufacturing
Environmental
Other conditions

Reference: FDA. PAT -- A Framework for Innovative Pharmaceutical

Development, Manufacturing, and Quality Assurance. September
2004

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 TERMINOLOGY: PROCESS VALIDATION
Process Validation – Process Qualification
Process Performance Qualification (PPQ)

Qualification Qualification
Equipment #1 HVAC
UO #1
Utilities
Equipment #2 Facilities
UO #2
Computers
Equipment #3
UO #3

Analytical methods validation

Cleaning process validation
Packaging process validation

Process is validated
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 FDA PROCESS VALIDATION GUIDANCE (2011)

Definition: Collection and evaluation of data, from the

process design stage throughout commercial production,
which establishes scientific evidence that a process is
capable of consistently delivering quality products.
Process validation involves a series of activities over the
lifecycle of the product and process.

Three stages of activities:

• Stage 1 – Process Design – Development and scale-up activities
• Stage 2 – Process Qualification – Reproducible manufacturing
• Stage 3 – Continued Process Verification – Routine manufacturing

STAGE 1 AND STAGE 3 EMPHASIS – NEW PARADIGM

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 FDA PROCESS VALIDATION GUIDANCE

“Before …commercial distribution to consumers, a manufacturer

should have gained a high degree of assurance in the performance
of the manufacturing process…consistently produce …”
Manufacturers should:
• Understand the sources of variation
• Detect the presence and degree of variation
• Understand the impact of variation on the process and product
attributes
• Control the variation in a manner commensurate with risk to process
and product.”
“…to justify commercial distribution of the product.”
“… use ongoing programs to collect and analyze product and process
data … state if control of the process.”
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 FDA PROCESS VALIDATION GUIDANCE

Good project management and good archiving to capture

scientific knowledge.
Enhance accessibility of information later in lifecycle.
Integrated team approach: Process engineering, industrial
pharmacy, analytical chemistry, microbiology, statistics,
manufacturing, and quality assurance.
Scientific studies throughout the product lifecycle planned,
documented, and approved.
Greater control over higher-risk attributes.
Reevaluate risks throughout product/process lifecycle.
Homogeneity with batch and consistency between batches
are goals of process validation.
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 STAGE 1, PROCESS DESIGN
(PROCESS UNDERSTANDING)
1. Building and capturing process knowledge and
understanding.
2. Establishing a strategy for process control.
Define commercial-scale process
Define unit operations and process parameters
Identify and understand sources of variability
Identify critical process parameters
Studies to understand effects of scale
Establish mechanisms to control variability
• Process Analytical Technology
Designed experiments
Lab scale and pilot scale experiments

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 PROCESS DESIGN (PROCESS UNDERSTANDING)
Objective
API and excipient pharmaceutics
Quality attributes
Risk analysis
Process parameters
Design of experiments
Design space
Normal operating range
In-process controls
Product development – key inputs to design stage
Variability by different component lots, production operators,
environmental conditions, and measurement systems
Use risk analysis tools to screen variables
Establish a strategy for process control
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 QUALITY BY DESIGN (QbD)
1. Quality target product profile (QTTP)
2. Critical quality attributes (CQA), critical material
attributes (CMA)
3. Critical process parameters (CPP)
4. Design space
5. Scale-up and technology transfer
6. Identify input variables
7. Input variable control strategy
8. Continuous improvement

Other considerations: PAT, Risk analysis

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 STAGE 2, PROCESS QUALIFICATION
(VALIDATION PERFORMANCE)

1. Design of a facility and qualification of utilities and equipment

2. Process performance qualification
3. PPQ protocol
4. PPQ protocol execution and report
Confirmation at commercial scale of process design information
Qualification of equipment, utilities, facilities
Performance qualification
Conclusion that process consistently produces quality product.
Conformance batches
• All support systems, documents, training, personnel, etc. in place
• Target / nominal operating parameters within design space
• Additional testing
• Decision to “release process” for routine commercial
manufacturing

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 STAGE 2, PROCESS QUALIFICATION
Conformance Lots

Procedures
Validation plans
Protocols
Sampling
Testing
Results
Plan to maintain validation
ALL EQUIPMENT, ANALYTICAL, AND SUPPORTING
SYSTEMS MUST BE QUALIFIED.

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 PERFORMANCE QUALIFICATION APPROACH
Higher level of sampling, testing, and scrutiny of process performance.
Protocol should address:
• Operating parameters, processing limits, and raw material inputs
• Data to be collected and how evaluated
• Test to be performed and acceptance criteria
• Sampling plan – sampling points, number of samples, frequency
• Statistical methods used
• Statistical confidence levels
• Provisions to address deviations and non-conformances
• Facility, utility, and equipment qualification
• Personnel training
• Status of analytical method validation
• Review and approval by appropriate departments and quality unit
DETAILS FROM PV GUIDANCE
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 PERFORMANCE QUALIFICATION APPROACH
“The PPQ lots should be manufacturer under normal conditions by
personnel expected to routinely perform each step of each unit
operation in the process. Normal operating conditions should cover
the utility systems (air handling and water purification), material,
personnel environment, and manufacturing procedures.”
PQ report:
• Discuss all aspects of protocol
• Summarize and analyze data as specified in protocol
• Evaluate unexpected observations and additional data
• Summarize and discuss non-conformances
• Describe corrective actions or changes
• Clear conclusions
• Approval by appropriate departments and quality unit

DETAILS FROM PV GUIDANCE

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 STAGE 3, CONTINUED PROCESS VERIFICATION
(VALIDATION MONITORING AND MAINTENANCE)

Activities to assure process remains in validated state

Annual Product Review
Trend and assess data
Study OOS and OOT (Out of Trend) data
Timely monitoring of critical operating and performance
parameters.
Monitor product characteristics, materials, facilities,
equipment, and SOP changes
Establish process history based on ongoing process
performance
Improve process
Improve control to detect and reduce variability
Change control; evaluate impact of change and test as
necessary
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 CONTINUED PROCESS VERIFICATION
Monitoring
Statistical process control
Trend analysis
Change control
Continuous improvement
Revalidation
Management review

STATISTICIAN RECOMMENDED BY FDA

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 CONTINUED PROCESS VERIFICATION
ITEMS TO BE REVIEWED
• Product and process data
• Relevant process trends
• Quality of incoming materials or components
• In-process material
• Finished products
• Defect complaints
• OOS findings
• Deviations
• Yield variations
• Batch records
• Incoming raw material records
• Adverse event reports
• Production operator and quality staff feedback

Above should help identify possible product / process improvements

DETAILS FROM PV GUIDANCE
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 SUMMARY OF GUIDANCE RECOMMENDATIONS
Stage 1: Product Design
• QTPP, Development information, Identification of CQA, CMA, and CPP
• Identification of sources of variation and control plan
• Experimental studies
• Technology transfer / scale up
Stage 2: Process Qualification
• PPQ protocol requirements
• Statistical sampling and acceptance criteria
• Equipment qualification and analytical method validation
Stage 3: Continued Process Verification
• Post PQ plan
• APR, batch data, yields, deviations, OOS, non-conformances, etc.
• Incoming material data
• Change control
• Statistical analysis of data / control charting
• Product complaints
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 PROCESS VALIDATION HISTORY

1978
CGMP includes Validation

1987
Development -- VALIDATION -- Control

2008-2011
Lifecycle approach
Continuum of understanding – validation – maintenance

UNDERSTANDING -- VALIDATION -- MAINTENANCE

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 VALIDATION PHILOSOPHY
• Validation is confirmation.
• Acceptable (passing) results are expected.
• Validation is not
– R&D
– Final stage of development process
– Optimization
– Fine-tuning
– Debugging

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 SUMMARY
Lifecycle Approach to Process Validation
• New document
• Compilation of concepts pre-2000 to current
• Three stages identified
– Understand
– Demonstrate
– Maintain
• Comprehensive
• Detailed improvements

QUESTIONS:
DOES THIS MAKE SENSE?
HOW DO YOU APPROACH VALIDATION?

60
 SUMMARY
WHERE WE ARE -- CURRENT PRACTICE

R&D Validation Commercialization

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SUMMARY -- VALIDATION – CURRENT PRACTICE

Emphasis on repeatability (3x)

One-time effort
Documentation important
Last step in development
“Hope we can pass validation”
Required for product release to market
Key regulations:
• 1987 Process Validation Guidance
• 1990’s Pharma Inspection Guidelines
• 1997 Medical Device Quality Systems Manual

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 SUMMARY -- WHERE WE ARE GOING –
LIFECYCLE APPROACH TO PROCESS VALIDATION

Lifecycle approach:
• Validation is never completed
• Validation is always ongoing

Objectives:
• Scientific and technical process
• Demonstrate process works as intended
• Process must remain in control throughout lifecycle

EFFECTIVE DOCUMENTS CONSISTENT WITH THE ABOVE

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 LIFECYCLE APPROACH TO PROCESS VALIDATION
Process Design
• Studies to establish process
• Identify critical process parameters
• Identify sources of variation
• Consider range of variation possible in processes
• Process understanding
Process Qualification
• Equipment, facilities, and utilities
• Confirm commercial process design
• Validation performance
Continued process verification
• Monitor, collect information, assess
• Maintenance, continuous verification, process improvement
• Change control
• Validation maintenance

“The process of process validation.”

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 SUMMARY
PROCESS VALIDATION HISTORY

1978
CGMP includes Validation

1987
Development -- VALIDATION -- Control

2008-2011
Lifecycle approach
Continuum of understanding – validation – maintenance

UNDERSTANDING -- VALIDATION -- MAINTENANCE

65
 SUMMARY
VALIDATION -- FUTURE
Development Performance Maintenance

Stage 1 à Stage 2 à Stage 3

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PAUL L. PLUTA, PhD
Editor-in-Chief
Journal of Validation Technology
Journal of GXP Compliance
Advanstar Communications

Adjunct Associate Professor

University of Illinois at Chicago (UIC) College of Pharmacy
Chicago, IL, USA

Pharmaceutical industry experience

Contact: paul.pluta@comcast.net

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