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Legacy Equipment /
System Qualification
21St Annual Validation Week
October 2015
Yau Kai Wong
This presentation is the opinion expressed during this presentation are those of the
presenter and do not represent the views, policies or practices of my employer,
or regulatory agencies.
1. What is Legacy Equipment
2. Issues with Legacy Equipment
3. Regulatory Standards
4. Objective of Legacy
Equipment Qualification
5. Remediation / Qualification
Process
Agenda
Terminology Equipment
Apparatus used to conduct the
required process or test or a
piece of process equipment
(e.g., a mill or a centrifuge)
or to a containment system
to complete a major step of
a recipe step
System an organization of engineering
components, which have a
defined operational function,
e.g., piping, instrumentation,
processing equipment, facilities,
facilities, computer hardware,
computer software, etc.
Terminology cont’d
Qualification The practice of establishing
that equipment operatesas it was designed for its
intended use in a
reproducible manner
Validation Established documented
evidence which provides a high
degree of assurance that a
specific process will consistently
produce a product meeting its predetermined specifications
and quality attributes
Terminology cont’d
Verification
The process of evaluating
the products of a given
phase to ensure
correctness and
consistency with respect
to products and standards
provided as input to that
phase.
Legacy Equipment / System
Definition There is no formally accepted
definition for “Legacy”
equipment / system
GAMP Good Practice Guide
(PGP) – a “Legacy” system
should be considered to be
an GxP relevant system that is
in place and in use, and
which id deemed not to
satisfy current regulatory
expectations.
Legacy Equipment / System
Definition cont’d
In Computing, a legacy
system is an old method,
technology, computer
system, or application
program, “of relating to,
or being a previous or
outdated computer
system”
Reasons for Keeping a
Legacy Equipment / System The system works satisfactorily
The costs of redesigning or replacing
the system are prohibitive
Retraining on a new system would
be costly in lost time and money
The system requires near-consistent
availability
The way the system works is not well
understood
The user expects that the system
cab easily be replaced when this
becomes necessary
Newer systems perform undesirable
Disadvantages with Legacy
Equipment / System
Ownership of equipment /
system
Qualification / validation
documentation
Cost of maintenance
Hard to maintain
Integration with newer
equipment / systems
Equipment functionalities
Security / Data integrity
Data archival
Regulatory Standard
CFR – 21 CFR
ICH – GMP
Industry – ISPE, ASTM
Corporate – Policies,
Quality Manual,
SOPs, Directives
Objective of Legacy Equipment
/ System Qualification
To meet the requirement
that facilities, systems,
equipment and utilities
are properly qualified
and maintained to
assure data and product
integrity
Forms the starting point
for future change control
Objective of Legacy Equipment
/ System Qualification cont’d
To provide a framework to
demonstrate regulatory
compliance To ensure that the legacy
equipment / system
properly supports the
process
Objective of Legacy Equipment
/ System Qualification cont’d
Enhance confidence in the
engineering of the legacy
system
Potentially to reduce system
maintenance costs
Demonstrate that
users are
competent to operate the legacy
system
Objective of Legacy Equipment
/ System Qualification cont’d
To establish a complete
set of system
documentation providing
a precise definition of the
operating environment,
functionality, hardware
and software, procedures
and reference manuals
associated with the
legacy system
Qualification / Remediation
It is not possible to undertake the details of an Installation Qualification for established equipment / system nor the detailed approach for an Operational Qualification, nevertheless there should be data available that support and verify the operating parameters and limits foe the critical variables of the operating equipment
The calibration, cleaning, preventative maintenance, operating procedures, and operator training procedures for the use of the equipment should be documented and in use
Risk-based
Remediation / Qualification
Approach
Life Cycle
Risk-Based Approach Clearly communicate the risk
assessment objectives
Define the risk levels
high, medium, low
1, 2, 3
Other methods
Determine business process
criticality
Determine the test plan and
test cases The rigor / scale of testing should
reflect the risk determined
Verification
Life Cycle Approach
Requirement
Risk Assessment
Qualification
Configuration
Management
Change Management
Deviation Management
Requalification
Management
ISPE LifeCycle
Maintain the Validated State
Operational procedures
Change management
Security management
Incident management
Performance monitoring
Periodic review
Backup, recovery, and
disaster recovery
Retirement
Periodic Review
22
System ID # & location
Validation status
System security & access
Backup and restore &
decommissioning
Deviation
Change control
CAPAs
Audit trail
Case Study
• IV solution manufacturing company
• Packaging line
CSV Remediation
Remediation Process Flow
Remediation Process
Scope
Assessment
Planning
Qualification Specification
Configuration
Reporting
Gap Assessment Template
User Requirement
Specification
Can one go back to re-create
user requirement?
Is this a value added proposition?
What is the purpose of re-
creating the URS?
System DescriptionSystem 1
System 2
System 3
System Overview
ISPE: An Example of System Overview Diagram for Process and Data Flow of a HPLC
System Description /
Functional Specification
Template
Risk Assessment1. Business Risk
2. Patient Safety, Product Quality
Risk Assessment cont’d
Criticality of Functions
Likelihood of Occurrence
Risk Assessment cont’d
Likelihood of Detection
Example of Risk Assessment
Risk AssessmentMeasure(s) to Mitigate
Risk
Main Function
Sub-Function
Risk Scenario
Cause of Risk
Probability Occurrence
(L/M/H)
Impact(s) on Specified Function
Severity of Impact(L/M/H)
Risk Classification(Level 1/2/3)
Probability of Detection(L/M/H)
Risk Priority(H/M/L)
URS
Function 1 Sub-fct 1 Stop Not enough grease
M Machine not able to run
H 1 H M PM
Function 2 Data can be missing when the role is forwarded to approval
Technical L Role required data not completed
H 2 H L Test thoroughness
UR 1
FS # Hazard
Severity of Harm
Probability of Occurrence
Risk Assessment
Mitigation
Function 1 <Destruction of system due to power surge
Critical Low Medium Install the system onto a UPS
Function 2 Specialized/proprietary construction has limited replacements
Critical Low Medium
Function 3 Loss of system function due to network disruption
Major Low Low Local storage or backup>
Example of Risk Assessment
Qualification & Verification
Based on the assessed risk
Set up verification templates
Verify the intended functions
Perform additional tests
Follow the system lifecycle