This document provides an overview of equipment qualification terminology and processes. It discusses conducting a risk assessment to determine validation requirements and maintaining qualified equipment. The key points covered include defining user requirements, performing installation qualification to verify proper installation, and operational qualification to confirm the equipment operates as intended. Maintaining qualification involves ongoing change control and periodic review.

1. Equipment Qualification – Fit for Intended Use
IVT
18th Annual Validation Week™
October, 2012
Presented By:

2. Agenda
• Equipment Qualification – Terminology
• Intended Use - User Requirements
• Maintaining the Qualified State
• Interactive Exercise
• Bonus Material
IVT Validation Week - October, 2012 2

3. Terminology
• Risk Assessment- Determines the ability/likely hood that the
subject equipment can impact product quality, efficacy, patient
or care provider safety.
• Commissioning - The purpose of Commissioning is to
establish confidence that the equipment or system is safe and
functional and that it meets established requirements and
specifications. For equipment or systems with a direct or
indirect affect on product quality, commissioning establishes that
the equipment or system is ready for turnover to qualification
and validation. Turnover at the end of commissioning also
places the equipment or system under formalized change
control. For projects where formal FAT, SAT, or Commissioning
activities are not performed, those activities must be completed
during the Qualification phases.
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4. Terminology (cont.)
• Factory Acceptance Test (FAT)
The purpose of FAT is to establish confidence that the equipment or system is tested to the
extent possible at the manufacturer’s facility and that it is ready for shipment and installation
at the operational site. The extent of testing is agreed with the manufacturer in advance and
is documented in a test plan or protocol. FAT activities may include:
Verification that the equipment or system has been constructed in conformance
with the Purchase Order and other Engineering specifications.
Safety issues and concerns have been addressed if applicable (e.g. Safety
Assessment).
Any software associated with the equipment or system has been verified for
proper installation and security.
The equipment will perform the specified operations as designed and
documented
Any issues or concerns are addressed by the vendor prior to shipment and
acceptance by the customer.
All required drawings, documents, cut-sheets, sequence of operations, etc. are
properly documented and delivered by the vendor.
Reference to documented results in the FAT may be appropriate for subsequent
qualification activities if it was planned, executed, and documented to a sufficient
level to do so.
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5. Terminology (cont.)
• Site Acceptance Test (SAT)
The purpose of SAT is to establish confidence that the equipment or system has been built to design
specifications, assembled, and debugged by the manufacturer at the operational site, and that it is
ready for turnover to the customer for acceptance. The extent of testing is agreed with the
manufacturer in advance and is documented in a test plan or protocol. Once the SAT is approved
the customer owns the equipment.
Typically the SAT is a repeat* of the FAT along with testing for anything that was discovered,
repaired, redesigned, etc. during or after the FAT.
SAT activities may include:
Visual and or other inspections to ensure no damage occurred during shipment.
Reassembly if the equipment had to be shipped in pieces due to size or other issues
Verification that the equipment or system has been constructed in conformance with the
Purchase Order and other Engineering specifications.
Any software associated with the equipment or system has been verified for proper
installation and security.
Start up and running with the site utilities to ensure the equipment operates the same
as at the FAT
All required drawings, documents, cut sheets, sequence of operations are complete and
appropriate from the vendor.
*Reference to documented results in the SAT may be appropriate for subsequent
qualification activities if it was planned, executed, and documented to a sufficient level to do so.
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6. Terminology (cont.)
• Installation Qualification – Documentation of objective evidence
showing that the equipment has been installed according to
specifications (manufacturer’s recommendations)
• Operational Qualification - Documentation of objective evidence
showing that the equipment operates according to specifications (User
Guide, User Requirements)
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7. What’s the difference between Validation and
Qualification?
Validation means confirmation by examination and
provision of objective evidence that specified requirements
have been fulfilled. (CFR 21 Part 820.3 (z))
Qualification
• Not defined by FDA
• Subset of validation
• Provides documented evidence that the subject
equipment has been installed per specification
(manufacturer's recommendations) and will attain and
maintain critical process parameters repeatedly and
reliably.
• Typically done as part of a larger validation effort.
• May support multiple validation efforts. (see slide #26)
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8. Getting Started
Validation Team
The Project Leader is responsible to form a multi-functional team to
plan and oversee the validation activities. A team approach
assures that the validation processes are well thought out, the
protocols are comprehensive, and that the final packages are well
documented and easy to follow. Members of the validation team
could include representatives from or personnel with expertise in:
• Quality Assurance (must be a member of all validation teams)
• Engineering
• Manufacturing
• Others depending on facility organization and equipment/product
types:
o Laboratory
o Technical Services
o Research & Development
o Regulatory Affairs
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9. Getting Started
For all phases described, the Project Team must:
• Determine what, how and when to verify/measure.
• Determine how many to verify/measure, i.e. statistical
significance.
• Define acceptance/rejection criteria.
• Identify required documentation.
• The division of responsibilities and activities must be
determined by the Project Team based on the Risk
Assessment to provide a high degree of assurance that
the equipment under test is suitable for its intended
purpose.
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10. Intended Use
User Requirements - A stand alone document that is
common for computer systems. For equipment User
Requirements come from many sources.
Commercial Off The Shelf (COTS) equipment, they usually
take the form of Owners’ Manual or Users’ Guides. Maybe a
Request for Quote (RFI) if the equipment is custom.
Other sources:
• Set up sheets
• Design of Experiment
• Parameter Limit Values
• Environmental requirements and/or constraints
• Manufacturer’s installation guide
Regardless of their origin they form the basis for your Risk
Assessments and Acceptance criteria
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11. Risk Assessment
CONDUCTING RISK ASSESSMENT
A risk assessment must be performed for all validations and
determines the documentation deliverables.
The risk assessment will determine the validation parameters of the
overall equipment or system and the required functions.
The assessment must also analyze the potential failure and fault
modes of the equipment or system to determine if the design is
appropriate and to gauge the
relative level of validation testing and
need for external safeguards.
Risk assessment must be conducted using methods appropriate to
the scope and nature of the validation project.
The conclusions of the risk assessment process may be included in
a project Validation Plan, in individual protocols, or in a separate
document.
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12. EQUIPMENT QUALIFICATION
REQUIREMENTS
The following GAMP V Model (Figure 1) demonstrates the
traceable approach to equipment qualification
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13. Don’t forget the software!
• Conducting GxP Assessment
All equipment systems must be assessed for their impact to patient
safety, product quality and data integrity. This assessment will be
accomplished by following SOP-MD-2010411, GXP Assessment
System Categorization.
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14. Validation Requirements Based on GxP
Assessment
Each piece of computerized equipment or computerized system
determined as GxP as a result of the GxP assessment is assigned
a criticality per SOP-XYZ based on the use and application of the
equipment with rationale.
Equipment criticality is assessed by performing risk assessment
directly on equipment or through process and/or product.
All equipment systems determined as GxP related are categorized
as Non-configured, Configured, or Custom.
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15. Computer System Validation requirements
Some Examples
Category Description Examples Requirements
o Molding tools o Product Risk Assessment
Process impact equipment with o Manual Press o Equipment Identification
Non-Computerized
no computerized component o Solvent Dispensers o Risk based test against process identified
parameters
o Firmware –based applications o Abbreviated life cycle approach
o COTS Software/equipment o Abbreviated (i.e. equipment specifications or
o Instruments manuals)
o Installation Qualification and version control
Run-time parameters may be
entered and stored, but the o Risk-based approach to supplier assessment
Non-Configured o Version control
software cannot be configured
to suit the business process. o Risk-based test against (for simple systems
regular calibration may substitute for testing)
o Verify procedures are in place for maintaining
compliance and fitness for intended use
o LIMS o Life cycle approach
o SCADA o Risk-based approach to supplier assessment
o Spreadsheets o Demonstrate supplier has an adequate Quality
o
Simple Human Machine
Interfaces(HMI) o
Management System
Some life cycle documentation (DS) retained by
Software that can be Note: specific examples of the above supplier.
configured by the user to meet system types may contain o Installation Qualification against Design
the specific needs of the user’s substantial custom elements. Qualification
Configured business/manufacturing o Operational Qualification against Functional
process. Software code is not Specification
altered. o Performance Qualification against .
o Version control
o Risk-based testing to demonstrate application
works as designed.
o Verify procedures are in place for maintaining
compliance and fitness for intended use
o Internally and externally Same as for configurable, plus:
developed IT applications o More rigorous supplier assessment.
Software custom designed and o Internally and externally o Possible supplier audit
Custom coded to suit the business developed process control o Possession of full life cycle documentation
process. applications o Design and source code review
Custom ladder logic
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16. Installation Qualification (IQ)
The purpose of the IQ is to establish by objective evidence
that the equipment as installed or modified. For equipment
qualifications, an IQ should contain these minimum
requirements.
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17. Installation Qualification
• Purpose
• Scope
• Equipment description
o Boundaries – ancillary equipment
• Environment
• Critical Utilities
• Drawings
• Preventive Maintenance
o Spare Parts
• Product Contact
o Cleaning procedures
o Materials of construction – Product Contact
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18. Installation Qualification (IQ)
Requirement/Content
Section
Purpose State the equipment needs to be qualified
Scope State whether the installation is for
o New equipment or
o Modifying previous qualified equipment
Equipment/ Describe what the equipment does, how it is used, what process/products use it, and its basic design features
System Description
Supplier Vendor certification and safety feature verification
Equipment Components • Identify and briefly describes each major component of the subject equipment
• Define the system/equipment boundaries with other systems or equipment
• Ancillary equipment used in conjunction with the equipment being qualified should be identified as appropriate
Utilities Utilities required to operate the equipment should be identified
Construction, Installation and • Specify the cleaning procedures that must be executed after the equipment is installed
Requirements • Document that the cleaning procedures have been successfully executed and completed
Supporting Documentation •
List supporting documentation that may be used to identify or operate the equipment such as Engineering
Turnover Packages, Purchase Orders, or Equipment Manuals
Maintenance Programs • Establish maintenance procedure
• Include a listing of any preventive maintenance activities
Spare/Change Parts Provide a list of spare parts and change parts, if applicable, required for system operation, including a description of
the part and part number of reference
Drawings List and include in the qualification protocol for the system drawings used to support the IQ
Testing and Acceptance Criteria • Acceptance criteria must be approved by the site designate review board or project team prior to executing any
IQ
• Define the test procedure; IQ testing must be designed to confirm that the equipment is installed in accordance
with manufacturers recommendation or document justification for exceptions
• Define the acceptance criteria; for an IQ this is usually a Pass/Fail result
Discrepancies Discuss and justifies events per required deviation or exception procedure
Summary and Conclusion • Summarize IQ test results, which demonstrate that the equipment was installed correctly
• Provide a conclusion on whether the equipment installation is acceptable
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19. Installation Qualification (IQ)
The IQ will document that the required design feature have
been properly installed. The number of design features can
vary from a few to any number of design features. Design
features are dependent upon the complexity of the
equipment.
The following slide contains examples of various design
features that may be considered.
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20. Installation Qualification (IQ)
Category Design Features
Equipment • Product contact materials of construction
• Labeling (marking/identification)
Process Piping • Material of construction
• Size
• Pressure test
• Insulation
Environment • Temperature
• Humidity
• Particulates (viable and/or non-viable)
Valves • Valve type
• Size
• Actuator type
Lubricants • Lubricant description
Commodity number
•
• Stock number
• Whether the lubricant has direct or incidental product contact
Safety Devices • Device type
• Product contact surface material
• Pressure and temperature rating (if applicable)
Alarms • Description of the alarm and whether they are Operational or Quality in nature
• Acceptance criteria
Instrumentation • Verify all instruments installed on the equipment/system are labeled appropriately and any
instruments deemed to require calibration or routine certification are within calibration and have
been entered into the calibration program
Utilities • Compressed gas connections
• Sample ports (if required), labeling and sizes
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21. Operational Qualification (OQ)
• User Guides/Manuals
• Critical Process Parameters
• Environment
• Critical Utilities
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22. Operational Qualification (OQ)
At minimum the OQ must include and/or address the items
in this section. Statistical tools such as design experiment
and/or response surface design should be applied to
optimize equipment and process performance.
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23. Operational Qualification (OQ)
Section Requirement/Content
Purpose State the equipment needs to be qualified
Scope State whether the installation is for
o New equipment or
o Modifying previous qualified equipment
Equipment/System Description Describe what the equipment does, how it is used, what process/products use it, and its basic design features
If above fully described in the IQ, then a reference to the IQ is acceptable
Operational Qualification Pre-requisites Verify all IQ tests have been completed prior to execution of operational qualification or that any IQ testing not yet completed
has been identified in a protocol exception report as non-critical for OQ testing to begin
Test Equipment Calibration Verification • A completed record of qualified test equipment and approved materials that is used during protocol execution
• List calibration date and next due date
Standard Operating Procedures • Establish operating, maintenance, setup and/or cleaning procedures for the equipment
• Procedure(s) shall be approved and effected before or by end of OQ is completed
Alarm/Control Challenges • Identify and challenge critical alarms associated equipment/system. Note: In some cases, the alarm studies may be
deferred to an overriding operating system, such as Building Management System or equivalent
• Challenge the equipment/system operator controls and indicators such as controllers not challenged as part of a
separate software validation package and buttons, lamps, switches, etc. that are used for control or monitoring of the
equipment
Operating Parameters • Verify the key and critical process parameters (some equipment may not have critical process parameters)
•
Notes:
Verify the operating ranges and acceptance criteria for each parameter
• Software parameters must also be considered; separate computer validation protocol can be used to address this
Rationale and Sampling Locations Provide rationale for:
• Qualification approach taken
• Sample size rationale
• Selected test conditions
• Critical parameters
Testing and Acceptance Criteria • Define the test range for each critical process parameter for verification
o The testing range typically “brackets” the operating range to ensure equipment is qualified with extra security;
e.g., if temperature operating range is 50°C to 100°C, then the test range should be 40°C to 110°C
• The process will be challenged at the extremes of the critical process parameters wherever possible.
• The number of test runs needs to be statistically justified and it may be depending on the complexity of the equipment
Test Result Documentation Summarize test results and confirms the acceptance criteria
Discrepancies Discuss and justifies discrepancies
Summary and Conclusion Summarize equipment OQ results and provide a conclusion on whether the equipment operation is acceptable
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24. Operational Qualification (OQ)
Equipment Employed for Multiple Products
When equipment is employed for multiple products, one may consider using
the proven acceptable range (PAR) approach. The establishment of PAR
to include operating and control parameters represents much of what
process validation is all about. The function of PAR is to include and
validate all corresponding control and operating ranges at the same time.
The following is an example of equipment that employing three products or
molds, for which temperature is one of the critical process control
variables.
The objective to challenge the operating range should test on the lowest
and highest proven acceptable limits.
Product A Product B Product C
Operating 90° -110° 85° - 100° 100° - 120°
Control 85° - 115° 80° - 105° 105° - 125°
Proven Acceptable 80° - 120° 75° - 110° 100° - 130°
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25. Maintaining the Qualified State
• Training
• Preventive Maintenance
o Spare Parts List
• Calibration
• Change Control
• Re-Qualification
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26. Re-Qualification
Re-Qualification Review
The validation status of qualified equipment must be
reviewed to determine whether it continues to operate in a
qualified state. With the exception of those processes that
are subject to regulatory requirements regarding time
specific intervals for periodic re-qualification, the change
control process is appropriate to determine re-qualification
requirements to maintain
the validated state.
As part of the Change Control process, a validation
assessment will be completed for each change to
determine and document any potential validation impact
and any actions deemed appropriate to ensure the
validation status is maintained including the possibility of re-
qualification. IVT Validation Week - October, 2012 26

27. Documentation Strategies
IQ OQ
IOQ
IVT Validation Week - October, 2012 27

28. Interactive Stuff
Participants develop an equipment qualification protocol
IVT Validation Week - October, 2012 28

29. BONUS Material
• Mold Validation Procedure
• Forms
• Production Equipment and Process validation Procedure
• GxP Assessment Procedure
IVT Validation Week - October, 2012 29