The document discusses risk-based approaches in GMP (Good Manufacturing Practices) project life cycles. It describes how to identify GMP projects, the benefits of a risk-based approach, and the typical structure and implementation of a GMP project life cycle. The life cycle includes phases for project origination, initiation, planning and design, execution and control, and close-out. It provides examples of tools and documents used in each phase, as well as who is responsible for key tasks and when they should be performed to successfully implement a risk-based GMP project life cycle. An interactive exercise is proposed to help apply the concepts.

1. Risk-Based Approaches in GMP’s Project
Life Cycles
Jorge A. Cordero-Monroig; BSChE, MBA-GM
Sr. Equipment/Control System Validation Engineer
B+L Greenville Solutions Plant
CONFIDENTIAL [1]

2. Risk-Based Approaches in GMP’s Project Life Cycles
Agenda:
 How to identify a GMP Project
 Why Risk-based Approach
 GMP Project Life Cycle – The Structure
 GMP Project Life Cycle – The Implementation
 Interactive Exercise: GMP Project Life Cycle – The Application
 Q&A
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3. Risk-Based Approaches in GMP’s Project Life Cycles
How to identify a GMP Project:
 GMP (Good Manufacturing Practices) - GMP is a group of practices
used to ensure that a product is consistently manufactured within quality
standards. In other words, practices that guarantee the strength-potency,
purity, quality, identity and safety of the product.
 What is a GMP Project – Any project that affect any equipment, control
system, software, process or facility (ECS-SPF) that have direct impact in
the safety, identity, potency-strength, quality and/or purity of the product.
 For example:
 Equipments: Mix Tanks (Reactors)
 Control Systems: DCS (Distribute Control System)
 Software: Blue Mountain (Calibration/Metrology Software)
 Process: Product Compounding // Cleaning // Chemistry final
product test.
 Facility: Clean Rooms (Class A / 100 / ISO 5) renovations
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4. Risk-Based Approaches in GMP’s Project Life Cycles
How to identify a GMP Project (Cont.):
 The first step to identify a GMP project is listing all the
equipment, control system, software, process or facility
(ECS-SPF) affected by the project.
 After break down all the equipment, control system,
software, process or facility (ECS-SPF) related with the
project, we need to perform an impact assessment for
each one.
 Impact Assessment Classifications:
 Direct Impact
 Indirect Impact
 No Impact
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5. Risk-Based Approaches in GMP’s Project Life Cycles
How to identify a GMP Project (Cont.):
 Direct Impact (ECS-SPF) shall answer YES to one of the
following questions:
 Does the ECS-SPF come in direct physical contact with the
product?
 Example: Filler, Tanks, Pumps, Agitators, etc…
 Does the ECS-SPF produce or distribute a material that has direct
contact with product?
 Example: Bottles/Caps Molding machines, Form Fill & Seal
(FFS) Machines, etc…
 Is the ECS-SPF used for cleaning, sanitize or sterilize?
 Example: SIP and CIP systems, Autoclaves, etc…
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6. Risk-Based Approaches in GMP’s Project Life Cycles
How to identify a GMP Project (Cont.):
 Does the ECS-SPF create or maintain a specified environmental
condition required to preserve product quality?
 Example: HVAC, Class A / ISO 5 rooms, etc…
 Does the ECS-SPF produce, monitor, evaluate, store or report
data used to accept or reject product or GMP materials or data
used to support Regulatory Compliance-Practices?
 Example: DCS, E-Batch Records, EMS, etc…
 Does the ECS-SPF perform a critical process step or operation in
the manufacturing, processing, packaging, labeling testing or
holding of the product?
 Example: Inspections Systems, Process Filters, scales, etc…
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7. Risk-Based Approaches in GMP’s Project Life Cycles
How to identify a GMP Project (Cont.):
 Indirect Impacts ECS-SPF shall answer YES to the
following question:
 Is the ECS-SPF linked or support a direct impact systems?
 Example: DI Water Systems, Chillers, Compressed Air Units,
etc…
 No Impact ECS-SPF answer NO to all previous questions.
 Example: Cooling Towers, Sand Filters, Office HVAC Units,
OEE Systems, etc…
 No impact ECS-SPF are not critical for the product quality
but could be critical for business purpose.
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8. Risk-Based Approaches in GMP’s Project Life Cycles
How to identify a GMP Project (Cont.):
 After classify the impact for the ECS-SPF projects, it is
important determine the risk level for the Direct Impact.
Indirect impact can be included in the risk analysis based on
the impact on business.
 Risk Assessments Categories:
 High
 Medium
 Low
 The purpose of the risk assessment classification is to focus on
issues that impact the patient safety, product quality and data
integrity on the early stages of the process.
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9. Risk-Based Approaches in GMP’s Project Life Cycles
Why Risk-based Approach
 What are the benefits of Risk-Based Approach?
 Identify and evaluate every single component, system, or
unit of the project.
 Classify each component, system, or unit of the project as
Direct, Indirect or No Impact.
 Justify decisions made based on risk criticality.
 Identify areas that will require more evaluation, adjustments,
or re-design prior to the implementation.
 Provide a solid rational of the project plan, schedule, and
project due date.
 Put more effort in the design stage of the process but
minimize the qualification effort which means less down
time.
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10. Risk-Based Approaches in GMP’s Project Life Cycles
Why Risk-based Approach
 What are the requirements of Risk-Based Approach?
 Determine the overall impact of the project in the patient
safety, product quality, and data integrity
 Analyze the risk to the business
 Identify risk to specific process
 Identify risk to specific functions
 Design to eliminate risk
 Define controls to mitigate risk that cannot be eliminated
 Define validation strategy
 Revise the risk assessments as require during the project
life.
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11. Risk-Based Approaches in GMP’s Project Life Cycles
Why Risk-based Approach
 Most Common Risk Assessments Models:
FMEA (Failure Modes & Effects Analysis)
FTA (Fault Tree Analysis)
HAZOP (Hazard Operability Analysis)
Risk Priority
Etc…
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12. Why Risk-based Approach
 Risk Priority:
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13. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Structure
 Project Phase Life Cycle :
 Project Origination
 Project Initiation
 Project Planning and Design
 Project Execution and Control
 Project Close-out
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14. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Structure
 Task and Responsibilities
 Project Origination
 Project identification: Process Owner (PO), Quality Assurance
(QA), or Process Excellence (PEx) based on business, and/or
regulation needs
 Project evaluation: By process excellence team
 Project selection: By upper management
 Project Initiation
 Project team development: Project Manager (PM)
 Project definition: Project Manager, Project Engineer (PE), PO, QA,
Procurement
 Initial risk identification: PEx, PO and QA
 Project plan: PM
 Project Plan Approval: Project team members
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15. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Structure
 Task and Responsibilities
 Project Planning and Design
Project meeting and expectations: Team Members
Refine project Definition:
– Scope: PE and PO
– Schedule: PM and PE
– Quality Standards: QA
– Budget: PM, PE, and Procurement
Approve Project Plan
Vendor Selection and PO approval: PE and
Procurement
Design Verification and approval: PE, PO, and QA
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16. ASC
GMP Project Life Cycle – The Structure
 Task and Responsibilities
 Project Execution and Control
Equipment, control system, software, process or facility
(ECS-SPF) development verification: PE, PO, and QA
Installation and Operational verification: PE and QA
Calibration, procedures, and preventive maintenance
implementation: PM and PO
 Project Close-out
Implementation verification: PM and PE
Risk Assessment Review: PEx, PO and QA
Close-out Letter: PM
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17. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Structure
 Tools:
 Project Origination:
 Project Proposal,
 Evaluation Rating Matrix
 Project Initiation:
 Project Charter
 Proposed Schedule
 Impact Assessment (GMP or Not GMP)
 User Requirement Specification
 Project Plan (Project Strategy)
 Budget Estimate
 Initial Risk Assessment (High/Medium/Low Risk)
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18. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Structure
 Tools:
 Project Planning and Design:
 Functional Requirement Specifications
 Functional Risk Assessment
 Traceability Matrix
 Revised Schedule
 Revised Budget
 Validation Strategy
 Design Specification/Qualification (DS/DQ)
 Project Execution and Control
 Factory Acceptance Test (FAT)
 Commissioning / Site Acceptance Test (SAT) / Engineering Studies
 Risk Assessment Review
 Qualification / Validation Protocols
 SOP’s, PM’s, and Calibration Program
 Project Close-out
 Traceability Matrix Review
 Closing Letter
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19. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Structure
 Phases Approach:
 After completion of each phase a formal Phase Review Report
should be evaluated and approved by the Project Team Members.
 Phase criteria should be completed before move to the next
phase.
 Incomplete criteria shall be justified on the Phase Review Report.
 Benefits of Phases Approach:
 Ensure that there is no missing elements during each phase.
 Force the team members to evaluate the project goals and
expectations constantly.
 Keep control of the project
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20. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Structure
 How to measure Success
 Align schedule with Phase Review Reports deliverables
 Project design mitigate, control, and measure the identified
risks
 User requirements, functional requirements, and design
specs were addressed and tested satisfactorily on FAT,
SAT, IQ, OQ, PQ, or PV.
 IOPQ and PV have been executed satisfactorily and
approved.
 Project has been implemented and closed as scheduled.
 Project cost are within the budget requested.
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21. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Implementation
 Who, How, and When:
– Change Control:
• Who: PM, PE, or PO
• How: Any project that affect a GMP equipment, control system,
software, process or facility shall be managed under local change
control process.
• When: Before start with the project execution and control phase.
– Schedule and Timing:
• Who: PM and PE
• How: Progress report and meeting should be implemented to
manage the schedule and keep visibility of the project progress.
Milestone shall be identified and addressed.
• When: Across the entire project, typically weekly.
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22. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Implementation
 Who, How, and When:
– Protocols and Verifications:
• Who: Vendor, Consultant, Operation personnel, PE, or QA-Validation
• How:
– FAT and SAT shall be reviewed an approved by quality in order
to be leverage on the IQ, OQ, and PQ. As specified on
Validation Strategy.
– FAT and SAT shall cover all details, configurations,
functionalities, and safety requirements.
– Limited IQ, OQ, and PQ can be performed based on FAT and
SAT successful test. PV, as applicable, to demonstrate that the
process is suitable for intended use (process is validated).
• When:
– FAT is performed at vendor facility. SAT performed at the site.
– Qualifications / Validation: After success FAT and SAT.
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23. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Implementation
 Who, How, and When:
– SOP’s and Preventive Maintenance:
• Who: PO, PE, and/ or Plant Engineer
• How:
– Update and/or create standard operational procedure and
preventive maintenance task, and include any critical
instrumentation to the calibration process.
– Include the changes in the Change control plan
• When:
– Update and development (draft) before the operational
qualification.
– Approved for the Performance qualification
– Effectives after qualification/validation completion but before start
the normal operation.
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24. Risk-Based Approaches in GMP’s Project Life Cycles
GMP Project Life Cycle – The Implementation
 Who, How, and When:
– Traceability Matrix, Risk Assessment Review and Closing Letter:
• Who: PM, or PE
• How:
– Using a matrix verify that all critical requirement in URS, FRS,
and DS, as applicable, were tested in one of the deliverables.
– Reviewing the Risk Assessment to confirm that the risk were
mitigated or controlled.
– Write a memo or project plan final report summarizing the
activities performance and completion.
• When:
– After approval of all qualification protocols final reports.
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25. Risk-Based Approaches in GMP’s Project Life Cycles
Interactive Exercise: GMP Project Life Cycle – The
Application
 Determine if the project is GMP or not GMP (Direct/Indirect/No
Impact)
 Outline a Project Life cycle
 Perform a Risk Assessment
 Manage Constraints
 Projects:
– Sampling Booth in a Warehouse
– Metrology Software
– Mix Tank (Reactor)
– Compressed Air
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26. Risk-Based Approaches in GMP’s Project Life Cycles
Bonus Material
 Risk Based Approach Project Life Cycle Phase Matrix
 Phase Review Report Template
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27. Risk-Based Approaches in GMP’s Project Life Cycles
Questions and Answers
?
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