A RISK-BASED APPROACH
TO COMMISSIONING &
QUALIFICATION
Hazem El-Eskandarani, P.E
Global Director, Commissioning & Qualification
ISPE Annual Conference
Singapore
August 2017
TRACK C
DESIGN, COMMISSIONING &
QUALIFICATION
A RISK-BASED APPROACH TO
COMMISSIONING & QUALIFICATION
AGENDA
What is Risk-Based Commissioning & Qualification?
Risk-Based versus Traditional Approach
Why Implement a Risk-Based Approach?
Regulatory Agencies & Risk-Based Qualification
Components of a Successful Risk-Based Approach
Tools to Implement a Risk-Based C&Q Program
Challenges to Implement a Risk-Based C&Q Program
Q&A
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What is Risk-Based Commissioning & Qualification?
A methodology to qualify only those design aspects that have been classified as critical-to-product-quality,
based on SMEs’ assessment.
All other design aspects are tested under commissioning (engineering testing).
Risk-Based methodology is based on 10 principles:
1. Focus on that which affects product quality
2. Process User Requirements key to acceptability
3. Risk assessments and process knowledge used to identify critical elements
4. Only critical features/functions to be qualified
5. All activities must contribute value
6. Risk-based asset delivery – not “cookbook” requirements
7. Value-added documents based on technical merit
8. Use of supplier documentation
9. Test planning (and “leverage” testing – redundant testing only when necessary)
10. Foster innovation – not all change is bad
ISPE White Paper “Risk Based Qualification for the 21st Century” March 2005
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Risk-Based versus Traditional Approach
Classic V-Model Risk Managed Model
• (Product) User Requirements not Formally Documented • Process Requirements Documented, Approved
• Protocols Developed from “Templates” • Risk Assessments Determine Critical Aspects of Design
• IQ/OQ Protocols QA “Preapproved” • Engineering Testing (“Commissioning”) Verification
• Commissioning not Leveraged • All Documents with Technical Merit Used as Evidence of Fitness for
Use
• Engineering and “Validation” Personnel Often Distinct
• Emphasis on Meeting Process Requirements
• Emphasis on Documents
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Why implement a Risk-Based approach?
Focus on impact to product quality & patient safety Number of Tests at Various Project Stages
Better posture for regulatory approval Number of Tests
Meets regulatory QbD expectations
Clear R&R
Quality team on the project focused on critical elements
SME approving most of the GEP documents
Significantly reduces the risk of issues at the end of projects
Expected savings in capital project cost & schedule Project Stages
(experience reflects around 25% savings)
Speedy regulatory review & approval
Life cycle management
COGs
All are critical business success factors
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Regulatory Agencies, Pharmaceutical Manufacturers &
Risk-Based Qualification
Risk based approach is not limited to the
US FDA, but is embraced by many
regulatory authorities around the world
Regulatory Expectations (FDA – Risk
Based, Process Validation guidelines, ICH
8,9 10)
> Design, operating, and quality
decisions should be based on
scientific knowledge of the
product and process.
> Risks to the product quality
should be understood and
managed
> A comprehensive quality
management system should be
implemented.
Regulatory Authorities that haven’t
adopted the risk-based approach are
willing to embrace it (CFDA in Xian is an
example)
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Regulatory Agencies, Pharmaceutical Manufacturers &
Risk-Based Qualification
ASTM International has issued a standard E2500 governing the
specification, design and verification process. The standard is
based on understanding and managing risks to the patient that may
be present in the manufacturing process equipment or facilities, and
also ensuring process requirements can be met. It provides some
guidance relating to how to conduct verification activities.
Note:- The FDA Process Validation Guide refers to this ASTM standard as an
acceptable approach for qualification.
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Components of a successful Risk-Based Approach
High level plan
Implementation process roadmap
Tools
Templates
Competent resources
Clear roles & responsibilities
Management support to implement
Integration with the big picture
ASTM E2500 – 13
Structured Approach
SME Quality Key
Science
Leadership Involvement Early Start
Leveraging Based
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Tools to implement a Risk-Based C&Q program
Process Flow Example (J&J SD&V Process Flow Diagram)
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Tools to implement a Risk-Based C&Q program
Logical sequence for
risk assessment,
Risk Assessment Example design reviews and
verification steps
Clear
definitions of
Risk tolerance each class
based on RPN
& company’s
internal policies
Full Traceability
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Challenges to implement a Risk-Based C&Q program
Culture Change / Risk adverse
Site-based Procedures & Practices
Transition Management
Flexibility
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Q&As
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