SlideShare una empresa de Scribd logo

Validation Program Design

•Descargar como PPTX, PDF•
•
B
bwbslide

A powerpoint presentation outlining Arc Engineering’s design philosophy for implementing/auditing a validation program.

1 de 13
Process Validation Assessment/Implementation Project Moog, Terumo & Arc Engineering February 9, 2011
Process Validation Overview & Objective Regulations, Guidance & Internal Controls Validation Lifecycle Approach & Risk Based Model QUEST - Five Step Method to Process Validation Question Understand Evaluate Site Assessment/Implementation Track Basecamp Website Conclusion
Process Validation Regulatory Requirements 21 CFR 820 – Medical Device Quality System Regulation Design Validation (820.30) Process Validation (820.75) Inspection Measurement & Test Equipment/Calibration (820.72) Supporting Requirements (i.e. 820.40: Document Control) Guidance Documents ISO 13485 – International Standard for Medical Device QMS’s GHTF SG3 - Process Validation, Risk Management Guidance Internal Documents (Moog & Terumo) Design History File (Who owns design validation and DFMEAs?) Industry Standards for Sensors? Control Plans, Job Travelers and PFMEAs Terumo specification documents or drawings?
Regulatory Requirements Design Validation Requirements (820.30) Demonstrates a process is operating within specified limits and consistently produces product complying with predetermined requirements Process Validation Requirements (820.75) Process monitoring & control Change Control & Deviation Management Systems Vitally important if the predetermined requirements of the product can only be assured by destructive testing So… what does this mean for device manufacturers?
How is Compliance Demonstrated? Ask yourself the following questions… Have your processes been subject to such scrutiny that the result can be practically guaranteed? Do you have confidence in your manufacturing processes? Do you have scientific evidence that your processes are capable of consistently delivering quality product? Have you demonstrated the process works as intended? Key Point: Documented evidence of process capability is critical
Validation Lifecycle Approach Monitoring Elements Design Elements ,[object Object]
Calibration
Process/Statistical Data
Training
Maintenance
Periodic Review
CAPA
Requirements

Recomendados

Introduction and scope of validation
Introduction and scope of validationIntroduction and scope of validation
Introduction and scope of validationJahnabi Sarmah
 
Implement Process Validation
Implement Process ValidationImplement Process Validation
Implement Process ValidationInstitute of Validation Technology
 
Pharmaceuticalvalidation maharaja mla
Pharmaceuticalvalidation maharaja mlaPharmaceuticalvalidation maharaja mla
Pharmaceuticalvalidation maharaja mlaMuthu Maharaja Mla
 
Process validation strategy
Process validation strategyProcess validation strategy
Process validation strategyprashik shimpi
 
Jatin validation
Jatin validationJatin validation
Jatin validationjatin singla
 
Introduction to Validation
Introduction to Validation Introduction to Validation
Introduction to Validation Masarrat Khan
 
Process validation
Process validationProcess validation
Process validationabhishek awasthi
 
New approach to Process Validation 4
New approach to Process Validation 4New approach to Process Validation 4
New approach to Process Validation 4Santosh Singh
 

Recomendados

Introduction and scope of validation
Introduction and scope of validationIntroduction and scope of validation
Introduction and scope of validationJahnabi Sarmah
 
Implement Process Validation
Implement Process ValidationImplement Process Validation
Implement Process ValidationInstitute of Validation Technology
 
Pharmaceuticalvalidation maharaja mla
Pharmaceuticalvalidation maharaja mlaPharmaceuticalvalidation maharaja mla
Pharmaceuticalvalidation maharaja mlaMuthu Maharaja Mla
 
Process validation strategy
Process validation strategyProcess validation strategy
Process validation strategyprashik shimpi
 
Jatin validation
Jatin validationJatin validation
Jatin validationjatin singla
 
Introduction to Validation
Introduction to Validation Introduction to Validation
Introduction to Validation Masarrat Khan
 
Process validation
Process validationProcess validation
Process validationabhishek awasthi
 
New approach to Process Validation 4
New approach to Process Validation 4New approach to Process Validation 4
New approach to Process Validation 4Santosh Singh
 
Revised Process Validation
Revised Process ValidationRevised Process Validation
Revised Process Validationpharmaakd
 
Validation of pharmaceutical dosage form
Validation of pharmaceutical dosage formValidation of pharmaceutical dosage form
Validation of pharmaceutical dosage formanurag chanda
 
Incorporate CPV and Continual Improvement into your Validation Plan
Incorporate CPV and Continual Improvement into your Validation PlanIncorporate CPV and Continual Improvement into your Validation Plan
Incorporate CPV and Continual Improvement into your Validation PlanInstitute of Validation Technology
 
Validation Master Plan
Validation Master PlanValidation Master Plan
Validation Master PlanInstitute of Validation Technology
 
Change control
Change controlChange control
Change controlSyeda Abeer
 
Validation of friability test apapraturs
Validation of friability test apapratursValidation of friability test apapraturs
Validation of friability test apapratursRam Mohan S R
 
009 what are the systems validation protocol methods at atl 05 28-2015
009 what are the systems validation protocol methods at atl 05 28-2015009 what are the systems validation protocol methods at atl 05 28-2015
009 what are the systems validation protocol methods at atl 05 28-2015atlmarketing
 
Vallidation
VallidationVallidation
VallidationDebajyoti Bhattacharya
 
Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)RushikeshPalkar1
 
Process validation
Process validationProcess validation
Process validationMd.Rakibul Islam
 
Process Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA ApproachProcess Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA ApproachGMP EDUCATION : Not for Profit Organization
 
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTSPHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTSMd. Saddam Nawaz
 
Manufacturing planning and self inspection in pharmaceutical industries
Manufacturing planning and self inspection in pharmaceutical industriesManufacturing planning and self inspection in pharmaceutical industries
Manufacturing planning and self inspection in pharmaceutical industriesSumita Sahoo
 
Process validation
Process validationProcess validation
Process validationSaravanan subramaniyam
 
Umer al faisal
Umer al faisalUmer al faisal
Umer al faisalKalim Ullah
 
Basic concept of process validation
Basic concept of process validation Basic concept of process validation
Basic concept of process validation Bishnu Koirala
 
Gmp change control by amsavel
Gmp change control by amsavelGmp change control by amsavel
Gmp change control by amsavelAmsavel Vel
 
Validation (intro, scope, merits, ich, who guidelines)
Validation (intro, scope, merits, ich, who guidelines)Validation (intro, scope, merits, ich, who guidelines)
Validation (intro, scope, merits, ich, who guidelines)PRAJAKTASAWANT33
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validationPavisara
 
Qualification validation ppt_171116
Qualification validation ppt_171116Qualification validation ppt_171116
Qualification validation ppt_171116Somnath Banerjee
 
Med day presentation
Med day presentationMed day presentation
Med day presentationCarsten Lund
 
Epsilon PræSentation
Epsilon PræSentationEpsilon PræSentation
Epsilon PræSentationcarsiew
 

Más contenido relacionado

La actualidad más candente

Revised Process Validation
Revised Process ValidationRevised Process Validation
Revised Process Validationpharmaakd
 
Validation of pharmaceutical dosage form
Validation of pharmaceutical dosage formValidation of pharmaceutical dosage form
Validation of pharmaceutical dosage formanurag chanda
 
Incorporate CPV and Continual Improvement into your Validation Plan
Incorporate CPV and Continual Improvement into your Validation PlanIncorporate CPV and Continual Improvement into your Validation Plan
Incorporate CPV and Continual Improvement into your Validation PlanInstitute of Validation Technology
 
Validation of friability test apapraturs
Validation of friability test apapratursValidation of friability test apapraturs
Validation of friability test apapratursRam Mohan S R
 
009 what are the systems validation protocol methods at atl 05 28-2015
009 what are the systems validation protocol methods at atl 05 28-2015009 what are the systems validation protocol methods at atl 05 28-2015
009 what are the systems validation protocol methods at atl 05 28-2015atlmarketing
 
Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)RushikeshPalkar1
 
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTSPHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTSMd. Saddam Nawaz
 
Manufacturing planning and self inspection in pharmaceutical industries
Manufacturing planning and self inspection in pharmaceutical industriesManufacturing planning and self inspection in pharmaceutical industries
Manufacturing planning and self inspection in pharmaceutical industriesSumita Sahoo
 
Basic concept of process validation
Basic concept of process validation Basic concept of process validation
Basic concept of process validation Bishnu Koirala
 
Gmp change control by amsavel
Gmp change control by amsavelGmp change control by amsavel
Gmp change control by amsavelAmsavel Vel
 
Validation (intro, scope, merits, ich, who guidelines)
Validation (intro, scope, merits, ich, who guidelines)Validation (intro, scope, merits, ich, who guidelines)
Validation (intro, scope, merits, ich, who guidelines)PRAJAKTASAWANT33
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validationPavisara
 
Qualification validation ppt_171116
Qualification validation ppt_171116Qualification validation ppt_171116
Qualification validation ppt_171116Somnath Banerjee
 

La actualidad más candente (20)

Revised Process Validation
Revised Process ValidationRevised Process Validation
Revised Process Validation
 
Validation of pharmaceutical dosage form
Validation of pharmaceutical dosage formValidation of pharmaceutical dosage form
Validation of pharmaceutical dosage form
 
Incorporate CPV and Continual Improvement into your Validation Plan
Incorporate CPV and Continual Improvement into your Validation PlanIncorporate CPV and Continual Improvement into your Validation Plan
Incorporate CPV and Continual Improvement into your Validation Plan
 
Validation Master Plan
Validation Master PlanValidation Master Plan
Validation Master Plan
 
Change control
Change controlChange control
Change control
 
Validation of friability test apapraturs
Validation of friability test apapratursValidation of friability test apapraturs
Validation of friability test apapraturs
 
009 what are the systems validation protocol methods at atl 05 28-2015
009 what are the systems validation protocol methods at atl 05 28-2015009 what are the systems validation protocol methods at atl 05 28-2015
009 what are the systems validation protocol methods at atl 05 28-2015
 
Vallidation
VallidationVallidation
Vallidation
 
Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)Validation ( process validation, TT from R&D to pilot plant)
Validation ( process validation, TT from R&D to pilot plant)
 
Process validation
Process validationProcess validation
Process validation
 
Process Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA ApproachProcess Validation for Beginners - FDA - EMA Approach
Process Validation for Beginners - FDA - EMA Approach
 
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTSPHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
PHARMACEUTICAL PROCESS VALIDATION CURRENT REGULATORY ASPECTS
 
Manufacturing planning and self inspection in pharmaceutical industries
Manufacturing planning and self inspection in pharmaceutical industriesManufacturing planning and self inspection in pharmaceutical industries
Manufacturing planning and self inspection in pharmaceutical industries
 
Process validation
Process validationProcess validation
Process validation
 
Umer al faisal
Umer al faisalUmer al faisal
Umer al faisal
 
Basic concept of process validation
Basic concept of process validation Basic concept of process validation
Basic concept of process validation
 
Gmp change control by amsavel
Gmp change control by amsavelGmp change control by amsavel
Gmp change control by amsavel
 
Validation (intro, scope, merits, ich, who guidelines)
Validation (intro, scope, merits, ich, who guidelines)Validation (intro, scope, merits, ich, who guidelines)
Validation (intro, scope, merits, ich, who guidelines)
 
Pharmaceutical validation
Pharmaceutical validationPharmaceutical validation
Pharmaceutical validation
 
Qualification validation ppt_171116
Qualification validation ppt_171116Qualification validation ppt_171116
Qualification validation ppt_171116
 

Destacado

Med day presentation
Med day presentationMed day presentation
Med day presentationCarsten Lund
 
Epsilon PræSentation
Epsilon PræSentationEpsilon PræSentation
Epsilon PræSentationcarsiew
 
FMEA Training
FMEA TrainingFMEA Training
FMEA Trainingwlanur54
 
Process validation fda
Process validation fdaProcess validation fda
Process validation fdaFasika Mekete
 
Effective medical device validation introduction manual advance
Effective medical device validation introduction manual advanceEffective medical device validation introduction manual advance
Effective medical device validation introduction manual advanceguest2d7d1cac
 
Concept of URS,DQ,IQ,OQ,PQ
Concept of URS,DQ,IQ,OQ,PQConcept of URS,DQ,IQ,OQ,PQ
Concept of URS,DQ,IQ,OQ,PQdhavalrock24
 

Destacado (8)

Med day presentation
Med day presentationMed day presentation
Med day presentation
 
Epsilon PræSentation
Epsilon PræSentationEpsilon PræSentation
Epsilon PræSentation
 
FMEA Training
FMEA TrainingFMEA Training
FMEA Training
 
Process validation fda
Process validation fdaProcess validation fda
Process validation fda
 
Fmea Example
Fmea ExampleFmea Example
Fmea Example
 
Effective medical device validation introduction manual advance
Effective medical device validation introduction manual advanceEffective medical device validation introduction manual advance
Effective medical device validation introduction manual advance
 
PROCESS VALIDATION
PROCESS VALIDATIONPROCESS VALIDATION
PROCESS VALIDATION
 
Concept of URS,DQ,IQ,OQ,PQ
Concept of URS,DQ,IQ,OQ,PQConcept of URS,DQ,IQ,OQ,PQ
Concept of URS,DQ,IQ,OQ,PQ
 

Similar a Validation Program Design

Effective Medical Device Validation Introduction Web 2
Effective Medical Device Validation Introduction Web 2Effective Medical Device Validation Introduction Web 2
Effective Medical Device Validation Introduction Web 2paulsorohan
 
Guidelines to Audit Validation Packages_RGA
Guidelines to Audit Validation Packages_RGAGuidelines to Audit Validation Packages_RGA
Guidelines to Audit Validation Packages_RGARosnelma García
 
Core tools apqp, ppap, fmea, spc and msa
Core tools apqp, ppap, fmea, spc and msa Core tools apqp, ppap, fmea, spc and msa
Core tools apqp, ppap, fmea, spc and msa Mouhcine Nahal
 
validationmasterplan-180918073044 (3).pdf
validationmasterplan-180918073044 (3).pdfvalidationmasterplan-180918073044 (3).pdf
validationmasterplan-180918073044 (3).pdfabdo badr
 
Validation master plan
Validation master planValidation master plan
Validation master planDr. Amsavel A
 
NASA Project Management Wall Chart
NASA Project Management Wall ChartNASA Project Management Wall Chart
NASA Project Management Wall ChartCarlos Duarte
 
Sample Product Management Lifecycle Presentation
Sample Product Management Lifecycle PresentationSample Product Management Lifecycle Presentation
Sample Product Management Lifecycle PresentationJulie Grosse
 
Software Quality Assurance
Software Quality AssuranceSoftware Quality Assurance
Software Quality Assurancelakshmi1693
 
1st technical dinner meeting
1st technical dinner meeting1st technical dinner meeting
1st technical dinner meetingfatimah-h
 
Software qualityassurance
Software qualityassuranceSoftware qualityassurance
Software qualityassurancesunilabj
 
Software Quality Assurance - Software Engineering
Software Quality Assurance - Software EngineeringSoftware Quality Assurance - Software Engineering
Software Quality Assurance - Software EngineeringPurvik Rana
 
Equipment Qualification.pptx
Equipment Qualification.pptxEquipment Qualification.pptx
Equipment Qualification.pptxNeeraj Kumar Rai
 
Facility & Equipment Quality System Outline
Facility & Equipment Quality System OutlineFacility & Equipment Quality System Outline
Facility & Equipment Quality System OutlineJoseph Busfield
 

Similar a Validation Program Design (20)

Effective Medical Device Validation Introduction Web 2
Effective Medical Device Validation Introduction Web 2Effective Medical Device Validation Introduction Web 2
Effective Medical Device Validation Introduction Web 2
 
Guidelines to Audit Validation Packages_RGA
Guidelines to Audit Validation Packages_RGAGuidelines to Audit Validation Packages_RGA
Guidelines to Audit Validation Packages_RGA
 
Core tools apqp, ppap, fmea, spc and msa
Core tools apqp, ppap, fmea, spc and msa Core tools apqp, ppap, fmea, spc and msa
Core tools apqp, ppap, fmea, spc and msa
 
V & V
V & VV & V
V & V
 
validationmasterplan-180918073044 (3).pdf
validationmasterplan-180918073044 (3).pdfvalidationmasterplan-180918073044 (3).pdf
validationmasterplan-180918073044 (3).pdf
 
Validation master plan
Validation master planValidation master plan
Validation master plan
 
NASA Project Management Wall Chart
NASA Project Management Wall ChartNASA Project Management Wall Chart
NASA Project Management Wall Chart
 
Module 12 Monitoring and Control I
Module 12 Monitoring and Control IModule 12 Monitoring and Control I
Module 12 Monitoring and Control I
 
Sample Product Management Lifecycle Presentation
Sample Product Management Lifecycle PresentationSample Product Management Lifecycle Presentation
Sample Product Management Lifecycle Presentation
 
Software Quality Assurance
Software Quality AssuranceSoftware Quality Assurance
Software Quality Assurance
 
Sanjeev - cv
Sanjeev - cvSanjeev - cv
Sanjeev - cv
 
Sanjeev cv
Sanjeev cvSanjeev cv
Sanjeev cv
 
1st technical dinner meeting
1st technical dinner meeting1st technical dinner meeting
1st technical dinner meeting
 
Ray-Goodfellow.ppt
Ray-Goodfellow.pptRay-Goodfellow.ppt
Ray-Goodfellow.ppt
 
Software qualityassurance
Software qualityassuranceSoftware qualityassurance
Software qualityassurance
 
Software Quality Assurance - Software Engineering
Software Quality Assurance - Software EngineeringSoftware Quality Assurance - Software Engineering
Software Quality Assurance - Software Engineering
 
SAP QM by Direct trainer
SAP QM by Direct trainerSAP QM by Direct trainer
SAP QM by Direct trainer
 
Equipment Qualification.pptx
Equipment Qualification.pptxEquipment Qualification.pptx
Equipment Qualification.pptx
 
Facility & Equipment Quality System Outline
Facility & Equipment Quality System OutlineFacility & Equipment Quality System Outline
Facility & Equipment Quality System Outline
 
Validation ksd
Validation ksdValidation ksd
Validation ksd
 

Validation Program Design

  • 1. Process Validation Assessment/Implementation Project Moog, Terumo & Arc Engineering February 9, 2011
  • 2. Process Validation Overview & Objective Regulations, Guidance & Internal Controls Validation Lifecycle Approach & Risk Based Model QUEST - Five Step Method to Process Validation Question Understand Evaluate Site Assessment/Implementation Track Basecamp Website Conclusion
  • 3. Process Validation Regulatory Requirements 21 CFR 820 – Medical Device Quality System Regulation Design Validation (820.30) Process Validation (820.75) Inspection Measurement & Test Equipment/Calibration (820.72) Supporting Requirements (i.e. 820.40: Document Control) Guidance Documents ISO 13485 – International Standard for Medical Device QMS’s GHTF SG3 - Process Validation, Risk Management Guidance Internal Documents (Moog & Terumo) Design History File (Who owns design validation and DFMEAs?) Industry Standards for Sensors? Control Plans, Job Travelers and PFMEAs Terumo specification documents or drawings?
  • 4. Regulatory Requirements Design Validation Requirements (820.30) Demonstrates a process is operating within specified limits and consistently produces product complying with predetermined requirements Process Validation Requirements (820.75) Process monitoring & control Change Control & Deviation Management Systems Vitally important if the predetermined requirements of the product can only be assured by destructive testing So… what does this mean for device manufacturers?
  • 5. How is Compliance Demonstrated? Ask yourself the following questions… Have your processes been subject to such scrutiny that the result can be practically guaranteed? Do you have confidence in your manufacturing processes? Do you have scientific evidence that your processes are capable of consistently delivering quality product? Have you demonstrated the process works as intended? Key Point: Documented evidence of process capability is critical
  • 6.
  • 12. CAPA
  • 17.
  • 19.
  • 20. Moog Process Validation Discussion Site Audit Review from August 2010… Discuss Process Validation Related Observations/Findings Associated CAPA QUEST Process Question Survey - (Completed) Kick-off meeting, initial walk-through & subsequent on-site visits Understand Supplier processes and industry specific standards Requirements and specifications (Acceptance Criteria) Risk assessment processes & process controls Product expectations from both Moog & Terumo
  • 21. Moog Process Validation Discussion QUEST Process… continued Evaluate Existing process validation elements employed by Moog Opportunities to improve process control & eliminate variation Addition of PV elements to existing QMS: Considerations: Cost, time, organizational maturity, culture & regulations The only things not “negotiable” are the program's objectives: System meets process requirements Risks to patients are adequately controlled Documented evidence of system controls are available
  • 22. Moog Process Validation Discussion QUEST Process… continued Site Assessment/Implementation Strategy & effort commensurate with the complexity and needs of the existing system Complex Multiple phase, continuous improvement approach to implementation “Rome wasn’t built in a day.” Validation Master Plan with equipment/process list & schedule Equipment Validation IQ/OQ Protocols & Reports Initial focus on ‘Direct Impact Equipment’ Process Validation Plans, Protocols & Reports Focus on critical quality attributes & critical process parameters Subsequent phases implement complementary systems including; Impact/risk assessment, maintenance, calibration, change control, document control/retention, training, periodic review & CAPA systems Simplistic Assessment & report for fully functioning Process Validation systems
  • 23. Moog Process Validation Discussion QUEST Process… continued Track Remember, Process Validation is a continuous cycle… Process Monitoring & Continuous Improvement activities include; Change Control CAPA Tracking & Trending Use of statistical software for objective process monitoring   Management review & evaluation equipment/instrument upgrades   Periodic review of qualification status Revalidation if applicable Customer audits verify system suitability
  • 24. Basecamp Website Basecamp offers: Project communication, messages, contacts, writeboards Planning and status tracking with to-do lists and milestones File sharing and storage Security and customizable permissions Benefits: Centralized, easily accessible, well documented, secure project records
  • 25. Conclusion Recap/Discussion/Questions Arc Engineering is always available and pleased to assist further, to provide insight and resolve any uncertainties! We look forward to a productive and mutually beneficial experience for Terumo and Moog!