Commissioning and Qualification From Traditional
Commissioning and Qualification From Traditional
Commissioning and Qualification From Traditional
Ricardo Girão
Tiago Pires
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Contents
▪ Basic Concepts
▪ Traditional Approach (Commissioning and Qualification)
▪ Guidelines for a more efficient approach
▪ The Verification Approach – Science & Risk Based
▪ New concepts and fundamentals
▪ (Examples)
▪ Final considerations
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OBJECTIVE
Traditional Verification
Approach Approach
(Science & Risk
(IQ;OQ;…) Based)
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Traditional Approach - Basic Concepts
• Qualification
As per ISPE Good Practice Guide: Applied Risk Management for Commissioning
and Qualification: “Qualification: is the demonstration of suitability for
intended use which has been formally documented and approved”
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Qualification Traditional Approach
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Qualification Traditional Approach
TRADITIONAL
TRADITIONAL QUALIFICATION
QUALIFICATION
RIGID PROCESS
RIGID PROCESS
Qualification
Issuing of Approval of Approval of Release for
IQ Testing OQ Testing Activities
IQ/OQ IQ OQ PQ/PV
Finished
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Qualification Traditional Approach
Example 1: Reactor / Tank Verification to open It is verified that it is
Qualification a certain valve another one that opens
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Qualification Traditional Approach
Example 2:
Option 1:
- Open a deviation to be evaluated and approved by the Q-Unit.
Option 2:
- Stop the Qualification / Project and wait for the instrument to be calibrated.
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Qualification Traditional Approach
• What is the added value of:
Efficiency (cost)
Product Quality
NO ADDED VALUE
(Risk Control)
Patient Safety
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GUIDELINES FOR A MORE EFFICIENT APPROACH
Key Concepts
▪ Describes a risk-based and science-based approach to specification, design,
and verification of manufacturing systems
▪ Intended to ensure that systems are fit for intended use, and to satisfy
requirements for design, installation, operation, and performance
▪ Encompasses all types of approaches - commissioning and qualification,
verification, system validation, or other.
▪ Applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs
for the 21st Century—A Risk-Based Approach
▪ Supports, and is consistent with, the framework described in ICH Q8, ICH Q9, ICH Q10,
and ICH Q11.
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Science & Risk Based Verification Approach
▪ Science-based – use of product and process information, such as Critical Quality Attributes
(CQA) and Critical Process Parameters (CPP) – in line with ICH Q8
▪ Identify Critical Aspects of the systems - functions, features, abilities, and performance or
characteristics to ensure consistent product quality and patient safety.
▪ Verification documentation shall be sufficiently flexible to be synchronized with the project
progress rather than to rigidly dictate the project execution
▪ Use Good Engineering Practices (GEP) to verify installation and operation, including vendor
documentation, and to address discrepancies not related with Critical Aspects
▪ Identify Subject Matter Experts (SME) and emphasize their role as key through all phases
▪ Re-focus the role of the Q-Unit to the approval of requirements, specs, test plans and
deviations related only with Critical Aspects for product quality and patient safety
▪ Design Reviews and Change Management to assure fitness for use through the system life-
cycle
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Qualification Traditional Approach
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SUBJECT MATTER EXPERT
▪ Defines or oversees:
– The verification strategy
– The verification deliverables
QA
– The verification activities
QRM
– The acceptance criteria
– The evaluation of deviations
– The release for use
SME
CQA; CPP GEP
Operations Engineering
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HOW TO GET THERE
https://ispe.org/publications/guid
ance-documents/good-practice-
guide-applied-risk-management-cq
Verification Approved by
Plan Quality Unit
Subject Matter Experts
Acceptance Approved by
and Release Quality Unit
Operation,
Continuous
Improvement
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Science & Risk Based Verification Approach
• Verification Process Application
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Science & Risk Based Verification Approach
Example 1: Reactor / Tank Verification to open It is verified that it is
Qualification a certain valve another one that opens
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Science & Risk Based Verification Approach
Example 2:
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Science & Risk Based Verification Approach
Example 3:
It is verified during the IQ that one instrument is not
calibrated.
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Science & Risk Based Verification Approach
Suggested Tools:
Use of Red-Lined documentation
Open Deviation (Usage of
Quality Unit Resources)
Ex:
Traditional
Testing: Verification of Missing a non-critical
P&ID instrument on an P&ID
Verification
Use of Red-Lined
documentation
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Science & Risk Based Verification Approach
▪ Initial Qualification – The particles equal to or greater than 0.5 μm should be measured.
▪ For Monitoring – The particles equal to or greater than 0.5 μm and 5 μm should be measured.
Traditional Verification
Approach Approach
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Science & Risk Based Verification Approach
Curiosity – Did you know how many times does the word “Risk” appears?
Traditional Verification
Approach Approach
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Science & Risk Based Verification Approach
Provide
clarification of QRM and Alignment with
roles and
responsibilities,
Science post-ICH Q8,
Q9 and Q10
with more Base regulatory
efficient use of
SMEs
Approach expectations
Improve
process
knowledge as Decrease
basis for projects
subsequent complexity and
operations and “bureaucracy”
life cycle Ensure focus is
maintenance on quality-
critical system
features
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FINAL CONSIDERATIONS
…just stop
here ...or may want
You may
stay here …or here to get there!
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REFERENCES
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Questions?
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