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Preliminary
Study
Product
Capacity
Market Size
Validation
master Plan
Feasibility
Study
Engineering
Conceptual
Detailed
Engineering
Basic Design
/Engineering
VMP, URS
BPOM
Approval
VMP
New Product
Formulation
Note :
: Consultant or supplier roles
: Done by Customer
Bidding Detail:
Engineering
& Cost Approval
Plant Design,
Automation and
Plant
Integration,
Building
HVAC
Electrical
B Automation
Waste
Processing
P Automation
Plant Integration
Civil Architecture
Commercial
Product
BPOM
Approval for
production
R
I
S
K
IMB,
AMDAL,
BKPM
Approvals
BPOM &
Headquarter
Approvals
Stability Test
Result
Facility
Improvement
A
N
A
L
Y
S
I
S
Tender
DQ
Detailed
Engineering
& Approval
Construction
Installation completed
IQ, OQ, PQ
Process Validation
Stability
Test
BPOM
Approval
for use of
facility
Ref. ISPE
Ref. ASTM
Scope
Summaries of requirement
1. Introduction
2. Overview Of The
Lifecycle
3. Requirements
4. Specification & Design
5. Verification, Acceptance
and Release
6. Continual Improvement
7. Quality Risk
Management
8. Good Engineering
Practice
9 . Design Review
10. Change Management
11--15.
Appendices
16. Appendix 6 Glossary
and Acronyms
17. Appendix 7
References
Note : Automation dealt
with throughout each
chapter
ASTM Process
Supporting
activities
Ref. ISPE
Objective
Requirements
As per the Contract
Exhibits:
Design Requirements
Technical Description and Drawing list
Specification of Equipment and Services
Commissioning Criteria and Performance Targets
Scope
Next
file P0031-033_QualityAssurancePlan.doc
1. Introduction
2. Scope
3. Facility Description
4. Commissioning
5. Qualification
6. Process Validation
7. Computer System
Validation
8. List of Required
Protocols and
Procedures
9. List of Required
Standard Operating
Procedures
10. Equipment and
Utility System
Descriptions
11. Computer System
Description
12. Other cGMP
Programs
13. References
Vacuum Mixing
Module
CIP Module
PW Generator
PW tank
and Loop module
Holding Module
URS-User Requirement Spesifications
AR/2015-09-15
LVP Module
PSG and
WFI Loop
LVP Filling
Machine
SVP Module
SVP Filling
Machine
URS-User Requirement Spesifications
AR/2015-09-15
Complete
line solutions
Integrated automation
Traceability
User Requirement
Specification
Ref. ASTM
Quality Assurance
Plan
Supplier selection
Procedure, Facility
Certification, etc.
Testing
Third party inspections
Factory Acceptance Test FAT - Dry
Factory Acceptance Test FAT Wet
Factory Acceptance Test FAT Product Test
Waste handling
Etc.
URS-User Requirement Spesifications
AR/2015-09-15
Pre-delivery Inspections
Factory Acceptance Test (FAT)
Box Opening Inspection
Health & Safety Risk Validation
Completed Installation Inspection
Commissioning Test
Performance Test
Performance Test
Thank you