SlideShare a Scribd company logo

DPL Compliance Road Map

•
•
T
t4uba
1 of 1
Download to read offline
Critical Parameter Trending Issue Purchase Orders The Road Map to GMP Compliance TRAINING CHANGECONTROL Dawat Pharma Ltd 83 Bescot Street, Walsall WS1 4HY United KingdomContact Dr Tanveer Ahmed Tel: +44 (0)7917 664718 Email: dr_t_ahmed@yahoo.co.uk Develop URSs Develop Basic Design Develop Process Rationale Project Brief Define Systems Develop Production SOPs Drawing Control System Supplier Audits Approve URSs Approve Basic Design Perform GMP Design Review Generate Procurement Packages Develop Detailed Design Detailed list of applicable requirements including: • Corporate & Site Standards • Applicable CGMPs • Regulatory Submission • Health & Safety • Good Engineering Practice • Environmental • User Requirements Perform HAZOP Review for HAZOPS, etc. Generate and Approve Project VMP Develop Batch Record Sheets Release Analytical Methods Compliance Audits Cleaning Validation Annual Product Review Validate Analytical Methods Establish Engineering Systems Facility Layout Drawings Equipment List Critical Instrument List P&IDs Current Calibration Certificates Certification for Contact Materials Certification for Contact Substances Spare Parts Lists Cleaning Procedures Maintenance Procedures Maintenance Schedules Cleaning Schedules Calibration Schedules System Categorisation Risk Assessments FAT SAT Software Testing Hardware Testing Generate & Approve QC VMP Generate & Approve PCS VMP Generate & Approve Facility VMP Generate & Approve Cleaning VMP Generate & Approve C&Q Plan Process Optimisation Operation Qualification Installation Qualification Performance Qualification Process Validation Routine Production GAMP URS Supplier Assessment Traceability Matrix Functional Specification Design Specifications Test Specifications Quality Plans SAT Commissioning FAT Revalidation Calibration Planned Preventative Maintenance

Recommended

FDA Update: Inspections, Observations and Metrics - OMTEC 2017
FDA Update: Inspections, Observations and Metrics - OMTEC 2017FDA Update: Inspections, Observations and Metrics - OMTEC 2017
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
 
PHARMACEUTICAL VAILIDATION
PHARMACEUTICAL VAILIDATIONPHARMACEUTICAL VAILIDATION
PHARMACEUTICAL VAILIDATIONSayali Powar
 
Validation of cms used for compliance with regulatory requirements in pharma ...
Validation of cms used for compliance with regulatory requirements in pharma ...Validation of cms used for compliance with regulatory requirements in pharma ...
Validation of cms used for compliance with regulatory requirements in pharma ...DeveshDRA
 
Computer system validation
Computer system validationComputer system validation
Computer system validationNitor Infotech
 
Computer System Validation
Computer System ValidationComputer System Validation
Computer System Validationchitralekha48
 
Computer system validation
Computer system validationComputer system validation
Computer system validationPayam Khorramshahi
 
PET - Calibration of QC Instruments for PET Radiopharmaceuticals Testing
PET - Calibration of QC Instruments for PET Radiopharmaceuticals TestingPET - Calibration of QC Instruments for PET Radiopharmaceuticals Testing
PET - Calibration of QC Instruments for PET Radiopharmaceuticals Testing@Saudi_nmc
 
PET - Total Quality Management
PET - Total Quality ManagementPET - Total Quality Management
PET - Total Quality Management@Saudi_nmc
 

Recommended

FDA Update: Inspections, Observations and Metrics - OMTEC 2017
FDA Update: Inspections, Observations and Metrics - OMTEC 2017FDA Update: Inspections, Observations and Metrics - OMTEC 2017
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
 
PHARMACEUTICAL VAILIDATION
PHARMACEUTICAL VAILIDATIONPHARMACEUTICAL VAILIDATION
PHARMACEUTICAL VAILIDATIONSayali Powar
 
Validation of cms used for compliance with regulatory requirements in pharma ...
Validation of cms used for compliance with regulatory requirements in pharma ...Validation of cms used for compliance with regulatory requirements in pharma ...
Validation of cms used for compliance with regulatory requirements in pharma ...DeveshDRA
 
Computer system validation
Computer system validationComputer system validation
Computer system validationNitor Infotech
 
Computer System Validation
Computer System ValidationComputer System Validation
Computer System Validationchitralekha48
 
Computer system validation
Computer system validationComputer system validation
Computer system validationPayam Khorramshahi
 
PET - Calibration of QC Instruments for PET Radiopharmaceuticals Testing
PET - Calibration of QC Instruments for PET Radiopharmaceuticals TestingPET - Calibration of QC Instruments for PET Radiopharmaceuticals Testing
PET - Calibration of QC Instruments for PET Radiopharmaceuticals Testing@Saudi_nmc
 
PET - Total Quality Management
PET - Total Quality ManagementPET - Total Quality Management
PET - Total Quality Management@Saudi_nmc
 
Lean Calibration Management
Lean Calibration ManagementLean Calibration Management
Lean Calibration Managementbossawines
 
PET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET RadiopharmaceutialsPET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET Radiopharmaceutials@Saudi_nmc
 
ISO17025 Accreditation Procedures and Process
ISO17025 Accreditation Procedures and Process ISO17025 Accreditation Procedures and Process
ISO17025 Accreditation Procedures and Process Abdul Rahman
 
FDA Form 483 (Inspectional Observations) - Top Violations 2013
FDA Form 483 (Inspectional Observations) - Top Violations 2013FDA Form 483 (Inspectional Observations) - Top Violations 2013
FDA Form 483 (Inspectional Observations) - Top Violations 2013Marc Sanchez
 
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
 
EMA Qualification & Validation Requirements
EMA Qualification & Validation Requirements EMA Qualification & Validation Requirements
EMA Qualification & Validation Requirements GMP EDUCATION : Not for Profit Organization
 
P rocess validation 1
P rocess validation 1P rocess validation 1
P rocess validation 1Malla Reddy College of Pharmacy
 
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012TEST Huddle
 
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersHow to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersGreenlight Guru
 
InstantGMP Compliance Series - Managing Deviations for Improved Compliance
InstantGMP Compliance Series - Managing Deviations for Improved ComplianceInstantGMP Compliance Series - Managing Deviations for Improved Compliance
InstantGMP Compliance Series - Managing Deviations for Improved ComplianceInstantGMP™
 
Pharmaceutical Documentation
Pharmaceutical DocumentationPharmaceutical Documentation
Pharmaceutical DocumentationCCL Pharmaceuticals
 
TOOLS OF CONTINUOUS IMPROVEMENT
TOOLS OF CONTINUOUS IMPROVEMENTTOOLS OF CONTINUOUS IMPROVEMENT
TOOLS OF CONTINUOUS IMPROVEMENTPharmaceutical
 
Pravin
PravinPravin
PravinPravin Jadhao
 
Increase profit with process analytical technology eoswiss engineering slide...
Increase profit with process analytical technology eoswiss engineering slide...Increase profit with process analytical technology eoswiss engineering slide...
Increase profit with process analytical technology eoswiss engineering slide...Georg Astl
 
1. validation
1. validation1. validation
1. validationsuresh suri
 
ISA 2nd process analytical technology conference
ISA 2nd process analytical technology conferenceISA 2nd process analytical technology conference
ISA 2nd process analytical technology conferenceMike Nager
 
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...Plan for Success Strategies to Align Reimbursement and Commercialization - OM...
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...April Bright
 
Item 3. Internal quality control - Quality Control Charts
Item 3. Internal quality control - Quality Control ChartsItem 3. Internal quality control - Quality Control Charts
Item 3. Internal quality control - Quality Control ChartsSoils FAO-GSP
 
Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?
Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?
Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?Triumvirate Environmental
 
Concept of validation
Concept of validationConcept of validation
Concept of validationMohammad Mudassar
 
Facility & Equipment Quality System Outline
Facility & Equipment Quality System OutlineFacility & Equipment Quality System Outline
Facility & Equipment Quality System OutlineJoseph Busfield
 
Reglera Corporate Introduction
Reglera Corporate IntroductionReglera Corporate Introduction
Reglera Corporate Introductionbriant
 

More Related Content

What's hot

Lean Calibration Management
Lean Calibration ManagementLean Calibration Management
Lean Calibration Managementbossawines
 
PET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET RadiopharmaceutialsPET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET Radiopharmaceutials@Saudi_nmc
 
ISO17025 Accreditation Procedures and Process
ISO17025 Accreditation Procedures and Process ISO17025 Accreditation Procedures and Process
ISO17025 Accreditation Procedures and Process Abdul Rahman
 
FDA Form 483 (Inspectional Observations) - Top Violations 2013
FDA Form 483 (Inspectional Observations) - Top Violations 2013FDA Form 483 (Inspectional Observations) - Top Violations 2013
FDA Form 483 (Inspectional Observations) - Top Violations 2013Marc Sanchez
 
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
 
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012TEST Huddle
 
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersHow to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersGreenlight Guru
 
InstantGMP Compliance Series - Managing Deviations for Improved Compliance
InstantGMP Compliance Series - Managing Deviations for Improved ComplianceInstantGMP Compliance Series - Managing Deviations for Improved Compliance
InstantGMP Compliance Series - Managing Deviations for Improved ComplianceInstantGMP™
 
TOOLS OF CONTINUOUS IMPROVEMENT
TOOLS OF CONTINUOUS IMPROVEMENTTOOLS OF CONTINUOUS IMPROVEMENT
TOOLS OF CONTINUOUS IMPROVEMENTPharmaceutical
 
Increase profit with process analytical technology eoswiss engineering slide...
Increase profit with process analytical technology eoswiss engineering slide...Increase profit with process analytical technology eoswiss engineering slide...
Increase profit with process analytical technology eoswiss engineering slide...Georg Astl
 
ISA 2nd process analytical technology conference
ISA 2nd process analytical technology conferenceISA 2nd process analytical technology conference
ISA 2nd process analytical technology conferenceMike Nager
 
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...Plan for Success Strategies to Align Reimbursement and Commercialization - OM...
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...April Bright
 
Item 3. Internal quality control - Quality Control Charts
Item 3. Internal quality control - Quality Control ChartsItem 3. Internal quality control - Quality Control Charts
Item 3. Internal quality control - Quality Control ChartsSoils FAO-GSP
 
Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?
Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?
Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?Triumvirate Environmental
 

What's hot (20)

Lean Calibration Management
Lean Calibration ManagementLean Calibration Management
Lean Calibration Management
 
PET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET RadiopharmaceutialsPET - Quality Assurance of PET Radiopharmaceutials
PET - Quality Assurance of PET Radiopharmaceutials
 
ISO17025 Accreditation Procedures and Process
ISO17025 Accreditation Procedures and Process ISO17025 Accreditation Procedures and Process
ISO17025 Accreditation Procedures and Process
 
FDA Form 483 (Inspectional Observations) - Top Violations 2013
FDA Form 483 (Inspectional Observations) - Top Violations 2013FDA Form 483 (Inspectional Observations) - Top Violations 2013
FDA Form 483 (Inspectional Observations) - Top Violations 2013
 
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)
 
EMA Qualification & Validation Requirements
EMA Qualification & Validation Requirements EMA Qualification & Validation Requirements
EMA Qualification & Validation Requirements
 
P rocess validation 1
P rocess validation 1P rocess validation 1
P rocess validation 1
 
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012
Ruud Cox - Testing in a Medical Device Context - EuroSTAR 2012
 
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning LettersHow to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
How to Prepare for an FDA Inspection and Respond to FDA 483's / Warning Letters
 
InstantGMP Compliance Series - Managing Deviations for Improved Compliance
InstantGMP Compliance Series - Managing Deviations for Improved ComplianceInstantGMP Compliance Series - Managing Deviations for Improved Compliance
InstantGMP Compliance Series - Managing Deviations for Improved Compliance
 
Pharmaceutical Documentation
Pharmaceutical DocumentationPharmaceutical Documentation
Pharmaceutical Documentation
 
TOOLS OF CONTINUOUS IMPROVEMENT
TOOLS OF CONTINUOUS IMPROVEMENTTOOLS OF CONTINUOUS IMPROVEMENT
TOOLS OF CONTINUOUS IMPROVEMENT
 
Pravin
PravinPravin
Pravin
 
Increase profit with process analytical technology eoswiss engineering slide...
Increase profit with process analytical technology eoswiss engineering slide...Increase profit with process analytical technology eoswiss engineering slide...
Increase profit with process analytical technology eoswiss engineering slide...
 
1. validation
1. validation1. validation
1. validation
 
ISA 2nd process analytical technology conference
ISA 2nd process analytical technology conferenceISA 2nd process analytical technology conference
ISA 2nd process analytical technology conference
 
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...Plan for Success Strategies to Align Reimbursement and Commercialization - OM...
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...
 
Item 3. Internal quality control - Quality Control Charts
Item 3. Internal quality control - Quality Control ChartsItem 3. Internal quality control - Quality Control Charts
Item 3. Internal quality control - Quality Control Charts
 
Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?
Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?
Lab Inspections vs. Audits: What's the Difference & Why Does It Matter?
 
Concept of validation
Concept of validationConcept of validation
Concept of validation
 

Similar to DPL Compliance Road Map

Facility & Equipment Quality System Outline
Facility & Equipment Quality System OutlineFacility & Equipment Quality System Outline
Facility & Equipment Quality System OutlineJoseph Busfield
 
Reglera Corporate Introduction
Reglera Corporate IntroductionReglera Corporate Introduction
Reglera Corporate Introductionbriant
 
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Greenlight Guru
 
Computerized system validation (CSV) as a requirement for good manufacturing ...
Computerized system validation (CSV) as a requirement for good manufacturing ...Computerized system validation (CSV) as a requirement for good manufacturing ...
Computerized system validation (CSV) as a requirement for good manufacturing ...Ahmed Hasham
 
Webinar: How to Ace Your SaaS-based EDC System Validation for Sponsors and CROs
Webinar: How to Ace Your SaaS-based EDC System Validation for Sponsors and CROsWebinar: How to Ace Your SaaS-based EDC System Validation for Sponsors and CROs
Webinar: How to Ace Your SaaS-based EDC System Validation for Sponsors and CROsStatistics & Data Corporation
 
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...PAT and QbD concepts in designing the LiMS and other Electronic systems in La...
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...balakrishna t
 
MedAccred Welcome Pack V13 160920
MedAccred Welcome Pack V13 160920MedAccred Welcome Pack V13 160920
MedAccred Welcome Pack V13 160920Adrien Boespflug
 
CCF PPT By Amit Gupta.pptx
CCF PPT By Amit Gupta.pptxCCF PPT By Amit Gupta.pptx
CCF PPT By Amit Gupta.pptxamitgupta273294
 
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
 
2016 V2 Bio Capabilities Statement
2016 V2 Bio Capabilities Statement2016 V2 Bio Capabilities Statement
2016 V2 Bio Capabilities StatementGreg Flood
 
Facility Qualification & Consideration of Validation Aspects
Facility Qualification & Consideration of Validation Aspects Facility Qualification & Consideration of Validation Aspects
Facility Qualification & Consideration of Validation Aspects Apoorva Bauskar
 
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
 
Validation and calibration of master plan
Validation and calibration of master planValidation and calibration of master plan
Validation and calibration of master planPrinka Choudhary
 

Similar to DPL Compliance Road Map (20)

Facility & Equipment Quality System Outline
Facility & Equipment Quality System OutlineFacility & Equipment Quality System Outline
Facility & Equipment Quality System Outline
 
Reglera Corporate Introduction
Reglera Corporate IntroductionReglera Corporate Introduction
Reglera Corporate Introduction
 
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...
Understanding the Medical device Single Audit Program (MDSAP) & How to Prepar...
 
Computerized system validation (CSV) as a requirement for good manufacturing ...
Computerized system validation (CSV) as a requirement for good manufacturing ...Computerized system validation (CSV) as a requirement for good manufacturing ...
Computerized system validation (CSV) as a requirement for good manufacturing ...
 
Chempharm Profile Presentation
Chempharm Profile Presentation Chempharm Profile Presentation
Chempharm Profile Presentation
 
Webinar: How to Ace Your SaaS-based EDC System Validation for Sponsors and CROs
Webinar: How to Ace Your SaaS-based EDC System Validation for Sponsors and CROsWebinar: How to Ace Your SaaS-based EDC System Validation for Sponsors and CROs
Webinar: How to Ace Your SaaS-based EDC System Validation for Sponsors and CROs
 
Dennis Mulrane Skills
Dennis Mulrane SkillsDennis Mulrane Skills
Dennis Mulrane Skills
 
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...PAT and QbD concepts in designing the LiMS and other Electronic systems in La...
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...
 
MedAccred Welcome Pack V13 160920
MedAccred Welcome Pack V13 160920MedAccred Welcome Pack V13 160920
MedAccred Welcome Pack V13 160920
 
CCF PPT By Amit Gupta.pptx
CCF PPT By Amit Gupta.pptxCCF PPT By Amit Gupta.pptx
CCF PPT By Amit Gupta.pptx
 
160702-JC-Auditing
160702-JC-Auditing160702-JC-Auditing
160702-JC-Auditing
 
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 ksd
Validation ksdValidation ksd
Validation ksd
 
concept of validation
concept of validationconcept of validation
concept of validation
 
2016 V2 Bio Capabilities Statement
2016 V2 Bio Capabilities Statement2016 V2 Bio Capabilities Statement
2016 V2 Bio Capabilities Statement
 
validation ppt.pptx
validation ppt.pptxvalidation ppt.pptx
validation ppt.pptx
 
Facility Qualification & Consideration of Validation Aspects
Facility Qualification & Consideration of Validation Aspects Facility Qualification & Consideration of Validation Aspects
Facility Qualification & Consideration of Validation Aspects
 
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
 
Implement Process Validation
Implement Process ValidationImplement Process Validation
Implement Process Validation
 
Validation and calibration of master plan
Validation and calibration of master planValidation and calibration of master plan
Validation and calibration of master plan
 

DPL Compliance Road Map

  • 1. Critical Parameter Trending Issue Purchase Orders The Road Map to GMP Compliance TRAINING CHANGECONTROL Dawat Pharma Ltd 83 Bescot Street, Walsall WS1 4HY United KingdomContact Dr Tanveer Ahmed Tel: +44 (0)7917 664718 Email: dr_t_ahmed@yahoo.co.uk Develop URSs Develop Basic Design Develop Process Rationale Project Brief Define Systems Develop Production SOPs Drawing Control System Supplier Audits Approve URSs Approve Basic Design Perform GMP Design Review Generate Procurement Packages Develop Detailed Design Detailed list of applicable requirements including: • Corporate & Site Standards • Applicable CGMPs • Regulatory Submission • Health & Safety • Good Engineering Practice • Environmental • User Requirements Perform HAZOP Review for HAZOPS, etc. Generate and Approve Project VMP Develop Batch Record Sheets Release Analytical Methods Compliance Audits Cleaning Validation Annual Product Review Validate Analytical Methods Establish Engineering Systems Facility Layout Drawings Equipment List Critical Instrument List P&IDs Current Calibration Certificates Certification for Contact Materials Certification for Contact Substances Spare Parts Lists Cleaning Procedures Maintenance Procedures Maintenance Schedules Cleaning Schedules Calibration Schedules System Categorisation Risk Assessments FAT SAT Software Testing Hardware Testing Generate & Approve QC VMP Generate & Approve PCS VMP Generate & Approve Facility VMP Generate & Approve Cleaning VMP Generate & Approve C&Q Plan Process Optimisation Operation Qualification Installation Qualification Performance Qualification Process Validation Routine Production GAMP URS Supplier Assessment Traceability Matrix Functional Specification Design Specifications Test Specifications Quality Plans SAT Commissioning FAT Revalidation Calibration Planned Preventative Maintenance