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Validation boot camp 2
1. VALIDATION BOOT CAMP #2
LIFECYCLE APPROACH TO
PHARMACEUTICAL VALIDATION –
PRINCIPLES, IMPLEMENTATION, AND PRACTICE
VALIDATION DOCUMENTATION
Paul L. Pluta, PhD
1
2. OUTLINE
• Validation Documents Overview
• Validation Policy Documents
• Stage 1 Process Design Documents
• Stage 2 Process Qualification Documents
– Validation Requests and Plans
– Validation Protocols
– Validation Results and Reports
• Stage 3 Continued Process Verification Documents
• Associated Documents
• Document Outlines / Templates
• Document Problems
2
3. IMPORTANCE OF VALIDATION DOCUMENTS
• Validation documents always requested in regulatory
audits
• Documentation is retained forever
• Documents reviewed long after people are gone
– Documents must “stand alone”
• Early documents (Request, Plan, Protocol) reviewed
when project is in-progress or not completed
• FDA auditors often focus on documentation – validation
documents often requested ahead of audit
Above sometimes difficult for technical people
3
4. SCOPE OF VALIDATION DOCUMENTS
FDA Process Validation Guidance has greatly expanded
the scope of validation
• Lifecycle approach – documents from development through
commercialization
• Traditional validation documents (protocol and results) less
important
Validation organizations should lead sites in transition to
lifecycle approach
• Multiple groups at site must now contribute to process validation
lifecycle approach documents
Lifecycle approach being applied to all validation and
qualification (equipment, facilities, cleaning, etc.)
4
5. VALIDATION DOCUMENTS -- BASICS
• Written for the reader – US vs. Europe
• Objective: Understanding
• Clarity much more important than brevity
• Stand-alone document
• Potential for review in 10+ years
• Author / Management not available for explanation
• Spelling and grammar correct
– Need good writers
– Simple sentences
– Simple words
5
7. VALIDATION POLICY
• Corporate or company policies
• High level overview documents
• Apply to all global manufacturing sites
• State agreement with local regulatory
requirements
• State agreement with customer regulatory
documents
• Specific corporate requirements
• Describe general validation approach
7
8. VALIDATION POLICY
Describe general validation approach
• Design and development . Science and technical
basis
• Validation performance
• Maintain validated state through monitoring, change
control, and management review
• Risk analysis – emphasis on highest risk
– Sampling, testing, acceptance criteria
• Variation identification and control
• Continuing improvements
GENERAL POLICY WITH KEY POINTS
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9. VALIDATION MASTER PLAN (VMP)
PROGRAM DESCRIPTION AT SITE
• Comprehensive lifecycle approach based on risk
• Consistent with general policy
MULTI-CHAPTER DOCUMENT
• Chapter for each major area (may have individual VMP per area)
– Process
– Equipment
– Facilities
– Analytical
– Computer
– Others
UPDATED AS NEEDED (Annual, quarterly, monthly)
• VMP must be current for audits
IMPROVEMENT PROJECTS COMMITMENTS AND TIMELINES
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10. VALIDATION MASTER PLAN (VMP)
SITE PROGRAM DESCRIPTION
• Design and development . Science and technical basis
• Validation performance
• Maintain validated state through monitoring, change
control, and management review
• Risk analysis – emphasis on high risk activities
• Variation identification and control
• Continuing improvements
10
11. VALIDATION MASTER PLAN (VMP)
CHAPTER CONTENT
Content for processes, cleaning, analytical, etc.
• Strategy and approach
• Procedures
• Supporting information (reference)
– Ex: Product validation families, Cleaning matrix
• Validation references
– Ex: Products, equipment, utilities, etc. document ID
• Validation commitments and timelines
• Improvement projects and timelines
11
12. VMP CHAPTER EXAMPLE – CLEANING VALIDATION
Strategy and approach
• Comprehensive lifecycle approach, Science and technical basis, Risk analysis,
Variation identification and control (consistent with site and corporate docs)
Procedures
• List of approved procedures
Supporting information with reference documentation
• Product cleaning matrix
• Equivalent equipment
• Equipment surface area calculations
• Residue calculations
• Technical reports
• Templates
Validation references
• List of all completed cleaning validation
Validation commitments and timelines
• Planned validations
Improvement projects and timelines
• Planned projects
12
13. STAGE 1 DOCUMENTS -- PROCESS DESIGN
Technical areas must be aware that their documents are critical to
validation throughout the product lifecycle.
• Direct support of Stage 2 PQ – their work is basis of validation
• R&D technical reports consistent with raw data
• Rapidly retrieved (within 30 minutes)
• Accessed throughout product lifecycle
• Personal support of regulatory audits
• Stand-alone documents
• Applies to processes, cleaning, analytical, equipment, facilities,
utilities, control systems, others.
R&D / TECHNICAL AREAS NOT ACCUSTOMED TO THESE
REQUIREMENTS AND EXPECTATIONS
13
14. STAGE 1 DOCUMENTS – POTENTIAL PROBLEMS
• Reports not available
• Reports not retrievable
• Reports incomplete
• Reports poorly written
• Reports not approved
• Personnel not available
• Original data not available
• Substandard documentation practices – original data
• No signature / date
• Data transpositions
• Data transfer problems
• Data transfer not verified
• Inconsistent data
• Multiple sources of same data inconsistent
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15. VALIDATION STAGE 2 DOCUMENTS
OPTIONS
• Outlines
• Templates
• Model documents
RECOMMENDATION
1. Develop outlines for authors – get agreements from
functional organizations and approval committee
2. Write or collect good documents
3. Documents available to writers
4. Replace (upgrade) as appropriate
15
16. STAGE 2 DOCUMENTS – PROCESS QUALIFICATION
VALIDATION REQUEST AND VALIDATION PLAN
INITIATION OF VALIDATION
Request: Statement of recommended validation
• What?
• Why needed?
• Why acceptable?
• Impact of validation – risk analysis
• Approach to accomplish – Validation Plan
• Approvals
Plan: Details of work to accomplish validation
• Description of strategy and approach
• References from Stage 1 work supporting validation
• Approvals
MAY BE SINGLE DOCUMENT OR TWO SEPARATE DOCUMENTS
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17. VALIDATION REQUEST OUTLINE
• Objective of validation
• Why needed?
• Impact of validation
– Risk analysis
• Why acceptable?
– Compliance to internal requirements, policies, engineering standards, etc.
– Regulatory impact (Prior approval, CBE, CBE30, etc.)
– Other systems or product impacted
– Procedure changes or other document changes
– Notifications to affected groups (internal, external, labs)
• Validation plan -- Approach to accomplish validation
Above applicable to equipment and other qualification
HAVE MODEL DOCUMENTS AVAILABLE
17
18. VALIDATION REQUEST -- PROBLEMS
• Poorly written
– Inadequate information
• Prematurely written
– Written to meet business goals
– Written to demonstrate future intent
• Amendments necessary -- changes usually required
Validation requests should be submitted for approval only
after objective and scope of validation is determined and
work details (risk/testing/sampling) determined.
Amendments are a planning failure regardless of
justification.
HAVE MODEL DOCUMENTS AVAILABLE
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19. VALIDATION REQUEST TERMINOLOGY EXAMPLES
Validation request:
Process validation of Product A
System: New product validation
Change impact: High impact. New product validation
Reason: New product to be manufactured at site
Acceptability:
• Compliant with policies
• Regulatory approval
• Other systems impacted (e.g., cleaning)
• Procedures approved
• Notifications (Labs)
Justification: See Validation Plan
Approvals
SIMPLE AND CLEAR
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20. VALIDATION REQUEST TERMINOLOGY EXAMPLES
Validation request:
Qualification of 150 cu. ft. blender
System: New equipment qualification
Change impact: High impact. New equipment and new size at site
Reason: New equipment to increase manufacturing efficiency and
throughput
Acceptability:
• Compliant with policy
• Regulatory approval
• Other systems impacted (e.g., cleaning)
• Procedures approved
• Notifications (Labs)
Justification: See Validation Plan
Approvals
SIMPLE AND CLEAR
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21. VALIDATION REQUEST TERMINOLOGY EXAMPLES
Validation request:
Change air supply and return ductwork to coincide with Line 1 floor space
changes
System: HVAC system #3
Change impact: Medium impact. Change to direct product contact support
utility
Reason: Room configuration change to increase manufacturing efficiency
Acceptability:
• Compliant with policy
• Regulatory approval not needed
• Other systems impacted
• Procedures approved, drawings modified, etc.
• Notifications
Justification: See Validation Plan
Approvals
SIMPLE AND CLEAR
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22. VALIDATION PLAN OUTLINE
• Introduction
• Technical information
• Validation strategy and testing
• Validation documentation
– List of required protocols, reports, procedures, etc.
– Administrative benefit
• References
– List of reports and scientific references (including Stage 1
reports)
HAVE MODEL DOCUMENTS AVAILABLE
22
23. VALIDATION PLAN
INTRODUCTION
• Overview describing validation / product / process /
equipment / etc. (consistent with request)
• Requirements to complete validation
– Conformance to regulations and internal policy
– Impact of change to maintain the validated state
– Impact on regulatory submission
– Impact of change on procedures, drawings, other documents
– Notifications to other areas internal and external (e.g.,
environmental agency, internal test labs) impacted by validation
23
24. VALIDATION PLAN
TECHNICAL INFORMATION
• Basic product / process / equipment description
– Formula
– Process
– Specifications
– Include non-technical description information
• Technical aspects of validation / qualification
• Reference to technical reports from Design Stage
• Total validation approach
– Experimental studies
– Past data (retrospective data)
– Validation protocols
– Other work
– New procedures
• Number of lots – related to impact of change and risk
WRITTEN FOR THE READER
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25. VALIDATION PLAN
VALIDATION STRATEGY AND TESTING
• Prospective validation only
• Types of testing -- general
– Regulatory specifications
– Internal controls
– Process tests
• Tests and rationale – general
– Address changes – based on risk analysis
• Sampling and rationale – general
– Exceed routine QA testing – based on impact and risk analysis
• Data treatment – general
– Statistical data treatment and confidence limits
• Acceptance criteria – general
DETAILS OF ABOVE PROVIDED IN PROTOCOLS
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26. VALIDATION PLAN
VALIDATION DOCUMENTATION
Doc # Title Date closed
01 Validation request
02 XXX Dryer Engineering Study
03 XXX Dryer Qualification
04 XXX Process Scale-up Engineering Study
05 XXX Process Validation
06 Update Validation Master Plan – Product and
Equipment sections
07 XXX Project Summary Report
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27. VALIDATION PLAN
REFERENCES
• R&D Reports
• Development and analytical reports
• Published literature
Scientific and technical support to validation plan
Report copies should be stored in validation area
or readily accessible (within 30 minutes)
27
28. PRODUCT / PROCESS DESIGN INFORMATION
• Technical reports from R&D
• Pharmaceutics reports
• Formulation and process development reports (CQA, CMA, CPP)
• Technology transfer / Scale-up reports
• Identification of sources of variation
• Variation control plans
• Analytical methods
• Other technical reports
REPORTS SHOULD BE REVIEWED FOR CONSISTENCY BETWEEN
GROUPS
REPORTS SHOULD BE REFERENCED IN VALIDATION PLAN
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29. TECHNICAL REPORTS
• Readily available
• Consistent across large technical groups
• Approved by management
• Linked to original data
– Observe / store original data
– Original documentation practices?
VALIDATION MUST REVIEW ORIGINAL DATA
• Rapidly retrievable
• Consistent with technical report
• Documentation practices
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30. VALIDATION PROTOCOLS
• Execution of the Validation Plan
• Testing details
• Sampling details
• Data sheets
• Data treatment
• Acceptance criteria
• Minimal text repetition from Validation Plan
PROTOCOL EASILY WRITTEN IF
VALIDATION PLAN IS THOROUGH
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31. VALIDATION PROTOCOL
• Objective of validation – specific protocol
• Validation description – specific
• Validation approach
• Testing and rationale -- specific
• Sampling and rationale -- specific
• Data sheets (summary)
• Data treatment -- specific
• Acceptance criteria – specific
– All testing must have acceptance criteria
– No FYI testing in validation
VALIDATION IS CONFIRMATION
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32. VALIDATION PROTOCOL
TESTING AND SAMPLING
• Based on product specifications and testing
• Exceed routine QA testing based on impact and risk
Consider the following:
• Product for seizures
• Product for hypertension
• New product
• Change in compressing machine
• Increase compressing machine speed
• Change in granulation method
• Change in batch size
Risk analysis in above
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33. VALIDATION PROTOCOL
FDA Powder Blends and Finished Dosage Units –
Stratified Sampling and Assessment
Blend sampling. n = 10, Individuals, RSD
Tablets. 20 samples, n = 3-7 per location, mean,
range, RSD.
Application is possible approach for high risk
products
Supportive of USP Uniformity of Dosage Units on
composite / stratified samples
Product types: Potency and weight testing
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34. VALIDATION SAMPLING
What is routine QA sampling?
Impact of change
• High impact
• Medium impact
• Low impact
• No impact
Risk analysis – Related to numerical RPN analysis
• High risk
• Medium risk
• Low risk
RISK LEVEL MUST BE ACKNOWLEDGED
34
35. ENGINEERING STUDY
• Conducted in advance of validation
• No acceptance criteria
• Trial run
• Examples: Manufacturing process without
bulk drug (low dose API)
• Process runs with placebo
• Categories of Engineering Studies
Conduct Engineering Study concurrently with validation?
-- Not recommended
35
36. SAMPLING PAGES
Designed sheet with space for expected data
Data treatment specified
Signature and data of person supplying data
Highly recommended for Operators or persons not
familiar with sampling
Data pages consistent with sampling pages
• Prevents missing data in complex protocols
• Record sampling and / or testing
36
37. SAMPLING / DATA PAGE EXAMPLE
UNIT OPERATION: Tablet compressing, lot # ________________
TEST: Content Uniformity (SOP # XX-XXX)
SAMPLE: 10 Tables each from beginning, middle, and end of batch
Sample #1 by _________ Date _________
Sample #2 by _________ Date _________
Sample #3 by _________ Date _________
TEST RESULTS (Circle P -- Pass or F -- Fail)
Sample #1 Sample #2 Sample #3
_____ P/F _____ P/F _____ P/F
_____ P/F _____ P/F _____ P/F
_____ P/F _____ P/F _____ P/F
_____ P/F _____ P/F _____ P/F
_____ P/F _____ P/F _____ P/F
_____ P/F _____ P/F _____ P/F
_____ P/F _____ P/F _____ P/F
_____ P/F _____ P/F _____ P/F
_____ P/F _____ P/F _____ P/F
_____ P/F _____ P/F _____ P/F
RECORDED BY:
__________ __________ __________
VERIFIED BY:
_____________ _____________ _____________
37
38. PROCESS VALIDATION PROTOCOL (PPQ)
FDA GUIDLINE RECOMMENDATIONS
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
• Status of analytical method validation
• Review and approval by appropriate departments and quality unit
38
39. VALIDATION PROTOCOL OUTLINE
Introduction
Unit operations
Testing with justification
Sampling with justification
Sampling and data pages
Data treatment
Acceptance criteria with justification
HAVE MODEL DOCUMENTS AVAILABLE
39
40. VALIDATION PROTOCOL -- PROBLEMS
No plan
No basic explanation of validation
No statement of strategy and approach
No test rationale
No sampling rationale
Missing samples – missing data
How to treat data
No discussion of results
No acceptance criteria rationale
No validation statement
Poorly written
WRITTEN FOR THE READER
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41. VALIDATION PROTOCOL -- PROBLEMS
How many lots should be tested?
Consider impact of change.
Consider product.
Consider process.
Consider risk.
ABOVE ADDRESSED IN VALIDATION PLAN
41
42. VALIDATION RESULTS
• Compilation of testing required in protocol
• Deviations or adverse events
• Discussion
• Conclusion
WRITE GOOD PLAN
PROTOCOL CONSISTENT WITH PLAN
RESULTS CONSISTENT WITH PROTOCOL
WRITE DISCUSSION FIRST – MOST IMPORTANT SECTION
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43. VALIDATION RESULTS OUTLINE
Introduction
Data sheets compiled
Data treatment
Results
Deviations, Non-conformances, etc.
Discussion
• “Results pass” is not sufficient.
Validation statement:
“Results indicate that ___ is validated.”
Post-validation monitoring plan
WRITE DISCUSSION SECTION FIRST – MOST IMPORTANT SECTION
HAVE MODEL DOCUMENTS AVAILABLE
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44. VALIDATION RESULTS PROBLEMS
• Missing data
• Documentation practices on raw data
• Raw data and results inconsistent
• Inadequate or no discussion of results
• Inadequate or no discussion of amendments or
deviations
• No conclusion statement
• Poor grammar and composition
44
45. VALIDATION RESULTS / REPORT -- PROBLEMS
Protocol requires BME samples for potency.
Acceptance criteria: 95-105%
B = 95%
M = 100%
E = 105%
All results pass
Conclusion?
POST PQ MONITORING?
45
46. VALIDATION RESULTS / REPORTS -- PROBLEMS
Protocol requires BME testing
Acceptance Criteria: Not More Than 6.0%
Results:
B = 2.0%
M = 2.1%
E = 6.0%
All data pass acceptance conclusions.
Conclusions?
POST PQ MONITORING?
46
47. VALIDATION REPORT
Recommended for complex projects
Recommended for multiple protocol projects
PRIMARY REPORT FOR AUDIT
“Cut and Paste” exercise from multiple documents
Best approach to avoid inconsistency
47
48. VALIDATION REPORT FORMAT
• Introduction
• Key information from Validation Plan
• Supporting information
• Protocol #1 results – “Cut and paste”
• Protocol #2 results – “Cut and paste”
• Protocol #3 results – “Cut and paste”
• Protocol #n results – “Cut and paste”
• Write transitional narrative
• Project conclusions (for Validation Plan)
• Validation statement
– “Results indicate that ______ is validated.”
HAVE MODEL DOCUMENTS AVAILABLE
48
49. STAGE 3 DOCUMENTS –
CONTINUED PROCESS VERIFICATION
POST PQ DOCUMENTS
TYPES OF DOCUMENTS
• Post PQ requirements – work required based on PQ
results
• Ongoing monitoring – routine process monitoring
49
50. STAGE 3 DOCUMENT RESONSIBILITIES
PQ REQUIREMENTS
Requirements specified in PQ results
• Continued monitoring of critical test results
– High risk activities
• Continued monitoring of aberrant values
• Continued monitoring of statistical (CL) failures
50
51. STAGE 3 DOCUMENT RESPONSIBILITIES
ONGOING MONITORING
RESPONSIBILITY
Monitoring results (Annual Product Review) QA
Change control validation results/reports and monitoring Validation
Non-conformances Production
Deviations Production
Process monitoring (control charts) QA
Process changes Production
Improvement projects instituted Validation
Other changes -----
Record of management review QA
ANNUAL REVIEW NOT GOOD ENOUGH,
ESPECIALLY FOR HIGH RISK PROCESSES
51
52. STAGE 3 DOCUMENTS
Regular management review of manufacturing data
Data analysis by statistical process control (SPC) principles
Review of all associated events, investigations, changes,
etc.
Record of management review
Expanded Annual Product Review, conducted at
appropriate intervals based on risk.
52
53. ASSOCIATED VALIDATION AND
QUALIFICATION DOCUMENTS
Equipment qualification
• All manufacturing process equipment and
associated control systems
• Example: Drug dispensing qualification
(equipment, facilities, HVAC, personnel, etc.)
• All facilities, utilities, systems, etc.
Analytical method validation
• Analytical equipment qualification
ABOVE MENTIONED IN PV GUIDANCE
53
54. EQUIPMENT, FACILITIES, UTILTIES, ETC.
QUALIFICATION
• IQ, OQ, PQ
• ASTM E2500
• Same approach as with processes
• Same philosophy
• Same requirements
• Same approval
• Critical tests only
• Non-critical tests in FAC, SAC, etc.
• Do as much as possible in commissioning
• Difference from PV: Do tests only once
• Validation statement –
– “Results indicate that _____is qualified.”
54
56. OTHER ASSOCIATED DOCUMENTS
Training records
• Operators
• Approvers
• Supervisors
Personnel qualifications
• FDA Warning Letter for inconsistent job
requirements (HR) and personnel resumes
Environmental monitoring history
Other
56
57. DOCUMENT OUTLINES / TEMPLATES
Document templates very difficult
• Labor intensive
• Do not fit every situation
Suggested approach
• Document outline of major sections
• Document outline evolves
• Model approved documents available
• Model approved documents improved and are
replaced
57
58. VALIDATION DOCUMENT APPROVAL
VALIDATION APPROVAL COMMITTEE (VAC)
VAC must review documents with perspective of an
external regulatory auditor
• Assure acceptability of technical validation and product
quality
• Assure compliance with regulations, policies, and
industry expectations
• Assure acceptability of documentation.
– Spelling and grammar
VAC IMPORTANT PARTNER WITH VALIDATION
58
59. VALIDATION DOCUMENT APPROVAL
Technical validation
• Scientific and technical principles
• Consistent approach
• Supports objective of validation
• Supports routine manufacturing in type of testing and
sampling
• Support routine manufacturing in duration of sampling
and testing
• Results and discussion support data
• Correct technical conclusions
• Equipment testing support entire operating range used in
manufacturing
59
60. VALIDATION APPROVAL COMMITTEE
• Training consistent with area of expertise
• Specialized training on validation function
• Emphasize role of internal auditor
VALIDATION APPROVAL COMMITTEE
IS NOT
Training for new personnel
Expeditor for engineering documents
60
61. PROCESS ANALYTICAL TECHNOLOGY (PAT)
Processes verified by PAT are not validated
All associated PAT equipment are validated
All associated PAT control systems are validated
All new analytical equipment is validated
All new analytical methods are validated
“WHEN PAT IS IN PLACE, WILL THERE BE ANY MORE VALIDATION?”
61
62. SUMMARY
COMPREHENSIVE, CONSISTENT, AND EFFECTIVE
VALIDATION DOCUMENTS
Validation documents consistent with validation guidelines and
expectations – based on risk
Policies and VMP
Stage 1 -- Emphasis on development work supporting Stage 2
• Technical basis for validation
Stage 2 -- Work should consider validation guidance recommendations
• Plans, protocols, results
Stage 3 – Emphasis on maintaining validated state through lifecycle
• Specific needs and routine monitoring
Associated documents
62
63. SUMMARY – VALIDATION POLICIES
• Corporate or company policies
• High level overview documents
• State agreement with local regulatory
requirements and customer regulatory
documents
• Describe general validation approach
• State key points from Process Validation
Guidance
• Risk-based approach
63
64. SUMMARY – VALIDATION MASTER PLAN
• Program description at site
• Multi-chapter document
• Updated as needed (annual, quarterly, monthly)
• Improvement projects commitments and
timelines
• Consistent with corporate policies
• State key points from Process Validation
Guidance
• Risk-based approach
64
65. SUMMARY – STAGE 1 DOCUMENTS
• Technical understanding of processes -- basis of
validation
• Reports readily available
• Accessed throughout product lifecycle
• Stand-alone documents
• Applies to processes, cleaning, analytical, equiment,
facilities, utilities, control systems, others.
R&D / TECHNICAL AREAS NOT ACCUSTOMED TO THESE
REQUIREMENTS
65
66. SUMMARY – STAGE 2 DOCUMENTS
VALIDATION REQUEST / PLAN
• Initiates validation
• Provides basis and details of future work
• Lists all specific requirements to complete
validation
• Administrative importance
• Most important document – all subsequent
documents based on validation plan
• Risk based
66
67. SUMMARY – STAGE 2 DOCUMENTS
VALIDATION PROTOCOLS
• Specific guidance requirements
• Strategy and approach
• Impact of change
• Risk based
• Testing and sampling rationale
• Acceptance criteria
• Statistical data treatment
• Data sheets
• Post-validation monitoring plan
67
68. SUMMARY – STAGE 2 DOCUMENTS
VALIDATION RESULTS / REPORTS
• Data sheets
• Discussion of results – Evaluate results
– Additional post-validation testing if necessary
• Validation statement – “___ is validated.”
• Summary report for multiple protocol validation
or complex projects
• Stage 3 Plan included in results document
• Most important validation document
• Simple sentences, simple words
• Written for the reader
68
69. SUMMARY – STAGE 3 DOCUMENTS
CONTINUED PROCESS VERIFICATION
• Specialized post-PQ requirements
• Routine monitoring
– Risk based
69
70. SUMMARY – ASSOCIATED DOCUMENTS
• Equipment, facilities, utilities, etc. qualification
• Analytical methods and equipment
• Training records
• Personnel qualification
• Environmental monitoring
70
71. SUMMARY – OTHER CONSIDERATIONS
• Follow FDA PV Guidance
• Use outlines
• Have model documents available
• Continually improve model documents
– Based on guidance requirements
– Example information to provide expectations for writers and
approvers
– Write most important document sections first
• Consider problem examples
• FMEA risk analysis included with validation plan
71
72. 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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