ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry
PROJECT TYPE MATRIX : Key Activities per Life Cycle Phase
PROJECT TYPE
General
Phase
Aspects within phase
PROJECT MANAGER
PROJECT FOCUS
Facility - New Build / Revamps /
Upgrades
Project Manager
Engineering
Product Transfer Project Manager
Process Improvement /
Development
Business Change Manager
Product Transfer
IT
Automation
Project Manager
Project Manager
PROJECT GOAL
Completion of a facility to a specified
level
Transfer manufacture and/or packing
from one site to another
Improving supply chain &
equipment/process rather than product
Delivery of a new or improved IT system
Completion of automation project (H/W
or S/W) to a specified level
INPUTS
Business Opportunity / Requirement
Business Opportunity / Requirement
Business Opportunity / Requirement
Business Opportunity / Requirement
Business Opportunity / Requirement
Initiation
KEY ACTIVITIES and
Deliverables
Business Sponsor
Business Sponsor
Business Sponsor
Business Sponsor
Business Sponsor
Project Governance
Project Governance
Project Governance
Project Governance
Project Governance
FEASIBILITY / CONCEPT DESIGN
FEASIBILITY
FEASIBILITY
REQUIREMENTS ANALYSIS
FEASIBILITY / CONCEPT DESIGN
User Requirements
Based on target facility capability
Based on pilot studies or data
Use Cases / User Requirements
User Requirements
Cost Estimate to +/-30%
Cost Estimate
Cost Estimate
Cost Estimate to better than +/-30%
Cost Estimate to +/-30%
Benefits Estimation
PROJECT PLANNING
Project Delivery Strategy
Plan for PDP Development Phase
Benefits Estimation
PROJECT PLANNING
Project Delivery Strategy
Plan for PDP Development Phase
Benefits Estimation
PROJECT PLANNING
Project Delivery Strategy
Plan for PDP Development Phase
Benefits Estimation
PROJECT PLANNING
Project Delivery Strategy
Plan for PDP Development Phase
Benefits Estimation
PROJECT PLANNING
Project Delivery Strategy
Plan for PDP Development Phase
OUTPUTS
Business Case
Technical Feasibility / Business Case
Technical Feasibility / Business Case
Business Case
Business Case
STAGE GATE
INPUTS
Is the project viable?
Approved pre-project funding
Is the project viable?
Approved pre-project funding
Is the project viable?
Approved pre-project funding
Is the project viable?
Approved pre-project funding
Is the project viable?
Approved pre-project funding
All previous development & planning
All previous development & planning
All previous development & planning
All previous development & planning
All previous development & planning
Appropriately resourced team
Appropriately resourced team
Appropriately resourced team
Appropriately resourced team
Appropriately resourced team
FRONT END DESIGN
FRONT END DESIGN
FRONT END DESIGN
FUNCTIONAL SPECIFICATION
FRONT END DESIGN
Outline drawings
PFD's
P&ID's
Cost Estimate +/- 10%
Specifications
PROJECT PLANNING
Project Execution Plan
Procurement Strategy
Validation Master Plan
Project Schedule
Risk Assessment
QA/QC Plan
Defined Technical Scope
Refined Business Case
Should this project go ahead?
Outline drawings
Scope of changes
PFD & P&ID modifications
Cost Estimate +/- 10%
Specifications
PROJECT PLANNING
Project Delivery Plan
Procurement Strategy
Validation Master Plan
Project Schedule
Risk Assessment
QA/QC Plan
Defined Technical Scope
Refined Business Case
Should this project go ahead?
PDP
KEY ACTIVITIES and
Deliverables
OUTPUTS
STAGE GATE
Scope of changes
PFD & P&ID modifications
Cost Estimate +/- 10%
Specifications
PROJECT PLANNING
Project Delivery Plan
Procurement Strategy
Validation Master Plan
Project Schedule
Risk Assessment
QA/QC Plan
Defined Technical Scope
Refined Business Case
Should this project go ahead?
Functional Specification
Pilot / Prototyping
Hardware Architecture / Spec
Cost Estimate +/- 10%
PROJECT PLANNING
Project Execution Plan
Procurement Strategy
Validation Master Plan
Project Schedule
Risk Assessment
QA/QC Plan
Defined Functional Scope
Refined Business Case
Should this project go ahead?
Functional Specification
Hardware Architecture / Spec
Cost Estimate +/- 10%
PROJECT PLANNING
Project Execution Plan
Procurement Strategy
Validation Master Plan
Project Schedule
Risk Assessment
QA/QC Plan
Defined Technical Scope
Refined Business Case
Should this project go ahead?
INPUTS
Implementation
KEY ACTIVITIES and
Deliverables
Fully approved funding
Appropriately resourced team
Fully approved funding
Appropriately resourced team
Fully approved funding
Appropriately resourced team
Fully approved funding
Appropriately resourced team
Fully approved funding
Appropriately resourced team
All previous development & planning
All previous development & planning
All previous development & planning
All previous development & planning
All previous development & planning
DESIGN
DESIGN
DESIGN
DESIGN
DESIGN
Specifications
Detailed Designs/Drawings
PROCUREMENT
Bid & Award Equipment
Bid & Award Contracts
Specifications
Detailed Designs/Drawings
PROCUREMENT
Bid & Award Equipment
Bid & Award Contracts
Specifications
Detailed Designs/Drawings
PROCUREMENT
Bid & Award Equipment
Bid & Award Contracts
PROCUREMENT
Bid & Award Equipment
Bid & Award Contracts
PROCUREMENT
Bid & Award Equipment
Bid & Award Contracts
CONSTRUCTION
CONSTRUCTION / MODIFICATION
CONSTRUCTION (modification)
CONSTRUCTION
CONSTRUCTION
Building construction
Equipment FAT
Equipment installation
Building construction
Equipment modifications
Equipment testing
Equipment modifications
Equipment testing
Handover & Closure
Equipment installation
Detailed Designs
Server / Software Installation
Software Coding / Configuration
Module / Unit Testing
System Testing / User Acceptance
Testing
Detailed Designs/Drawings
System Build
Software Configuration
System FAT
System Installation
COMMISSIONING
Verification Protocols
Verification Records
COMMISSIONING
Verification Protocols
Verification Records
COMMISSIONING
Verification Protocols
Verification Records
COMMISSIONING
Verification Protocols
Verification Records
OUTPUTS
Qualified facility ready for beneficial use
Qualified facility ready for beneficial use
Qualified facility ready for beneficial use
Qualified system ready for beneficial use Qualified system ready for beneficial use
STAGE GATE
INPUTS
Ready for handover?
Completed facility
Qualification documentation
Operating documentation
Ready for handover?
Modifications complete
Qualification documentation
Operating documentation
Ready for handover?
Modifications complete
Qualification documentation
Operating documentation
Ready for handover?
Completed system
Qualification documentation
Operating documentation
Ready for handover?
Completed system
Qualification documentation
Operating documentation
HANDOVER
HANDOVER
HANDOVER
HANDOVER
HANDOVER
Customer acceptance
Project final documentation
Project closure
CLOSURE
Learning review
Business case review
Beneficial Use review
Facility in beneficial use
Can the project be closed?
Customer acceptance
Project final documentation
Project closure
CLOSURE
Learning review
Business case review
Beneficial Use review
Facility in beneficial use
Can the project be closed?
Customer acceptance
Project final documentation
Project closure
CLOSURE
Learning review
Business case review
Beneficial Use review
Facility in beneficial use
Can the project be closed?
Customer acceptance
Project final documentation
Project closure
CLOSURE
Learning review
Business case review
Beneficial Use review
System in beneficial use
Can the project be closed?
Customer acceptance
Project final documentation
Project closure
CLOSURE
Learning review
Business case review
Beneficial Use review
System in beneficial use
Can the project be closed?
KEY ACTIVITIES and
Deliverables
OUTPUTS
STAGE GATE
COMMISSIONING
Verification Protocols
Verification Records