Kisi Kisi URS
Transcript of Kisi Kisi URS
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User Requirement Specifications
Tetra Pak Stainless EquipmentAgus Rascana
Tangerang, September 15th, 2015
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PreliminaryStudy
FeasibilityStudy
EngineeringConceptual
Flowchart of Buying Process
Rooms Layout, Personal& Material Flow, Plant
Layout, Utilities , HVAC,VMP, URS, Process
Basic Design/Engineering
BPOM &HeadquarterApprovals
VMP, URS
DetailedEngineering
BPOMApproval
ProductCapacity
Market SizeValidation
master Plan
DQ, Plant Layout,Architecture, Cost ofBudget Investment,
VMP, URS
IMB,
AMDAL,BKPM
Approvals
RISK
HVACElectrical
B AutomationWaste
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TenderCompile All Designs
Civil Architecture
Construction
Installation completedIQ, OQ, PQ
Process Validation
Stability TestResult
CommercialProduct
VMPNew ProductFormulation
NALYSIS
FacilityImprovement
DQ
BPOM
Approvalfor use offacility
Note :
: Consultant or supplier roles
: Done by Customer
Plant Design,Automation and
PlantIntegration,
Building
Bidding Detail:
Engineering& Cost Approval
DetailedEngineering& Approval
BPOMApproval forproduction
StabilityTest
ProcessingP Automation
Plant Integration
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Illustration of the validation and
qualification principles in GMP.
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Ref. ISPE
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Main Propose and Validation
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The Risk - Based Verification Process
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Ref. ASTM
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Scope and ApproachRequirements
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New commercial manufacturing and modification to
existing regulated manufacturing facilities
Planning, specification, design, and delivery
(harmonized) with GAMP 5
Scope
of the validation life cycle on which processvalidation is built
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(Product) User Requirements notFormally Documented
Protocols Developed fromTemplates IQ/OQ Protocols
Process Requirements Documented,Approved
Risk Assessments Determine CriticalAspects of Design
Traditional & RBA Based on ASTM E 2500
Approach and Method Validation
Preapproved Commissioning notLeveraged
Engineering And ValidationPersonnel Often Distinct
Emphasis on Documents NotSystem Performance
Engineering Testing (Commissioning)Verification
All Documents with Technical MeritUsed as Evidence of Fitness or Use
Emphasis on Meeting ProcessRequirements
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1. Introduction
2. Overview Of The
Lifecycle
3. Requirements
4. Specification & Design
8. Good EngineeringPractice
9 . Design Review
10. Change Management
11--15. Appendices
Summaries of requirement
5. Verification, Acceptanceand Release
6. Continual Improvement
7. Quality Risk
Management
16. Appendix 6 Glossaryand Acronyms
17. Appendix 7References
Note : Automation dealtwith throughout eachchapter
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ASTM- Risk Based Approach
ASTM Process
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Supportingactivities
Ref. ISPE
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Production Functionality Review
Objective To evaluate the ability of the functional design documents to
meet production related requirements in contract and toidentify deviations (if any) and agree necessary actions.
Requirements
Exhibits: Design Requirements Technical Description and Drawing list Specification of Equipment and Services
Commissioning Criteria and Performance Targets
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Production Functionality Review
Scope The works or agreed sections thereof as per documents
listed below. Process Technology Diagram Mass balance Production Time Schedule or manufacturin
characteristics Production Block Diagram Functional Diagram Automation System Configuration Machinery layout Single Line Diagram
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Next
Next and detail See file P0031-033_QualityAssurancePlan.doc
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Risk based approach
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Validation Master Plan
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Key Elements of validation Programme
The validation master plan (VMP) should reflectthe key elements of the validation programme.It should be concise and clear and contain atleast the following: a validation policy
Validation Master Plan
organ zat ona structure o va at on act v t es summary of facilities, systems, equipment and processes
validated and to be validated documentation format (e.g. protocol and report format) planning and scheduling
change control references to existing documents.
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1. Introduction
2. Scope
3. Facility Description
4. Commissioning
9. List of RequiredStandard Operating
Procedures
10. Equipment andUtility System
Typical VMP Contents
Validation Master Plan
.
6. Process Validation
7. Computer SystemValidation
8. List of RequiredProtocols andProcedures
escr p ons
11. Computer SystemDescription
12. Other cGMP
Programs 13. References
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Validation references
World Health Organization, WHO Technical Report
Series, No. 937, 2006, Annex 4, Supplementaryguidelines on good manufacturing practices:Validation
World Health Or anization WHO Technical Re ort
Validation Master Plan
Series, No. 937, 2006, Annex 4, Supplementaryguidelines on good manufacturing practices:Validation, Appendix 7, Non-sterile processvalidation
WHO good manufacturing practices: water forpharmaceutical use. Geneva, World, HealthOrganization 2005 (WHO Technical Report Series,
No. 929), Annex 3.AR/2015-09-15
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Quality Assurance &
Scope of Supply
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Productions solutions for Oral products
PW Generator
Vacuum MixingModule
CIP Module
PW tankand Loop module
Holding Module
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Production solutions for Parenteral
products
LVP Module
PSG andWFI Loop
LVP FillingMachine
SVP Module
CIP SIP ModuleSVP Filling
Machine
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Complete line solutions
Inte rated automation
Traceability
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User Requirement
Specification
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Product or application
General requirements for pharmaceutical watersystems
Water quality specifications Drinking-water Purified water
Equipment or systems is suitable for the
intended purpose
Highly purified water Water for injections Other grades of water
Application of specific water to processes and
dosage forms
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Product or application
Water purification methods General considerations
Production of drinking-water Production of purified water Production of highly purified water Production of water for in ections
Equipment or systems is suitable for the
intended purpose
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The Risk - Based Verification Process
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Ref. ASTM
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Quality Assurance
Plan
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Design Review and Risk Assessments
Review of Production Solution Functionality Production Functionality review Operation Functionality review
Review of Technical Design
Hygienic Risk Assessment
Health & Safety Risk Assessment
Project Quality Assurance Plan
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Implementation
Supplier selection
Procedure, Facility
Certification, etc.
Testing
Project Quality Assurance Plan
r party nspect ons
Factory Acceptance Test FAT - Dry
Factory Acceptance Test FAT Wet
Factory Acceptance Test FAT Product Test
Waste handling
Etc.
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Installation Completion
Pre-delivery Inspections
Factory Acceptance Test (FAT)
Box Opening Inspection
Health & Safety Risk Validation
Project Quality Assurance Plan
omp ete nsta at on nspect on
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Commissioning
Commissioning Test
Performance Test
Project Quality Assurance Plan
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Performance Validation
Performance Test
Project Quality Assurance Plan
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Thank you
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