Validation boot camp 2

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VALIDATION BOOT CAMP #2 LIFECYCLE APPROACH TO

PHARMACEUTICAL VALIDATION – PRINCIPLES, IMPLEMENTATION, AND PRACTICE

VALIDATION DOCUMENTATION

Paul L. Pluta, PhD

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

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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

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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.)

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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

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PROCESS VALIDATION DOCUMENTS •  Validation policy – Reference PV Guidance approach

–  Corporate templates

•  Validation Master Plan (VMP) – Reference PV Guidance approach •  Stage 1 documents – Process Design •  Stage 2 documents – Process Qualification

–  Validation Request / Plan -- Reference PV Guidance –  Validation Protocol(s) – Reference PV Guidance –  Engineering Studies –  Others –  Validation Results / Report – Reference PV Guidance

•  Stage 3 documents – Continued Process Verification –  PQ requirements –  Routine monitoring – Reference PV Guidance

•  Associated validation and qualification -- Reference PV Guidance •  Other associated documents

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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

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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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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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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

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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

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

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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

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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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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

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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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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

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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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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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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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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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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

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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

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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 24

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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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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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)

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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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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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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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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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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 32

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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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

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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

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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

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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: _____________ _____________ _____________

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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

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

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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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VALIDATION PROTOCOL -- PROBLEMS How many lots should be tested?

Consider impact of change. Consider product. Consider process. Consider risk.

ABOVE ADDRESSED IN VALIDATION PLAN

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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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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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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

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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?

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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?

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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

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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

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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

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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

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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

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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.

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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

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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.”

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ANALYTICAL

•  Analytical methods validated •  Analytical equipment qualified

•  QbD for analytical methods evolving

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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

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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

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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

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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

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

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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?”

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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

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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

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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

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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

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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

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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

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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

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SUMMARY – STAGE 3 DOCUMENTS CONTINUED PROCESS VERIFICATION

•  Specialized post-PQ requirements •  Routine monitoring

– Risk based

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SUMMARY – ASSOCIATED DOCUMENTS

•  Equipment, facilities, utilities, etc. qualification •  Analytical methods and equipment •  Training records •  Personnel qualification •  Environmental monitoring

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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

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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: [email protected]

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