Equipment Qualification Fit for Intended Use Presented by Justin Roose Head Validation Engineer – Product Quality Assurance (Global Compliance) 1
Equipment Qualification
Fit for Intended Use
Presented by Justin RooseHead Validation Engineer – Product Quality Assurance (Global Compliance)
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Session
Agenda
Introductions
Equipment Validation Requirements
Equipment Validation Execution
Installation Qualification
Operation Qualification
Performance Qualification
Deviations
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WHAT IS VALIDATION AND
WHY DO WE DO IT?
What is Validation
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Documented evidence that
processes, procedures, and
equipment lead to predetermined
expectations, specifications and
quality attributes.
What is Equipment Qualification
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Equipment used in the manufacture,
processing, packing, or holding of a drug
product shall be of appropriate design,
adequate size, and suitably located to
facilitate operations for its intended use
and for its cleaning and maintenance.
21 CFR 211.63
Why Validate
Validation ensures that the processes and
the equipment that are in place (or being
installed) function to meet the quality
requirements you committed to…
• your customers,
• government agencies,
• your manufacturing staff.
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Fit For Intended Use
• What is the definition?
FIT FOR INTENDED USE
Definition
• Capable to the job we want it to do?
• Does it do the job we bought it to do?
• Does it NOT do what we don’t want it to do?
Applies to New & Legacy Equipment Qual
Needs to be Defined up front in the process
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FIT FOR INTENDED USE
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WHERE & WHEN DO YOU
HAVE TO VALIDATE
Validation
Scope of Validation
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Equipment
Facilities & Utilities
Process & Packaging
Control & Information
Systems Software
Test Methods
Laboratory Equipment
Sanitizing
Cleaning
Scope of Validation
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Company Validation Policy
• Should include
• New and Legacy Equipment
• Risk Based Approach
WHAT IS THE EQUIPMENT
QUALIFICATION PROCESS
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MASTER PLAN
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Sanitary
Design
USP
Requirements
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Validation
Protocol
OSHA
Requirements Equipment
Codes
Industry
Design
Standards
ISO
Standards
Equipment
SpecificationsUser
Requirement
Documents
Intended
Use
Requirements Equipment
Manual
Pre-Qualification Activities
FAT
• FACTORY ACCEPTANCE TEST
• The testing of equipment for performance and reliability performed at the vendor before authorizing delivery.
SAT
• SITE ACCEPTANCE TEST
• The inspection and testing of equipment at the manufacturing site (in the plant) after delivery, installation, and debug to verify it is in the same condition as in the FAT.
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Qualification Activities
1. Write Protocol • Based on Fit for Use specification
• Based on other requirements
2. Execute Protocol
3. Address any Deviations in the Protocol
4. Create Final Report Summarizing the
Protocol
5. Close Out Qualification
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What does it take to do an
Equipment Qualification?
Equipment Qualification IQ/OQ/PQ are Built …
From the User Requirements Documents
From Manuals
To encompass range of products to be produced with subject equipment
For cGMP requirements
Data is obtained from the FAT and SAT results to update the final IQ, OQ, PQ protocols
For functional and debugged equipment
“ready for validation”
#1 Cause of Deviations
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EQUIPMENT
QUALIFICATION
REQUIREMENTS
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Lets focus on how to test
FIT for Intended USE?
INSTALLATION
QUALIFICATION
IQ OQ PQ
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Equipment Qualification (IQ)
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Documentation verification that all
aspects of a system, facility, utility or
equipment that can affect product
quality are installed according to
specifications and design criteria.
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Installation Qualification (IQ)
Equipment VerificationA• Basic Equipment Info: Make, Model, Serial Number, etc. – FIT FOR
USE?
Drawing List and DocumentationB
• Update and As-built
• P&IDs, Wiring/Logic/Loop Diagrams, Plan View
• Can be completed during SAT
Equipment Install VerificationC
• Ensure environment is suitable (outdoors, XP) – FIT FOR USE?
• Accessible for cleaning/maintenance – FIT FOR USE?
• Appears clearly labeled (ID, controls, safety)
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Installation Qualification (IQ)
Materials of Construction D• Includes lubricants (food grade – USDA H1)– FIT FOR USE?
• All product contact parts (i.e., Pump, Filler, Mix Tank)– FIT FOR USE?
• Attach material certs (preferred) or manufacturer material certification
Utilities VerificationE• All critical utilities required for proper operation of equipment
(i.e., electrical, water, compressed air, etc.)– FIT FOR USE?
Computerized Controls HW/SWF• For PLC or complex controls systems
• PLC software (i.e., title, version)
• Hardware – make/model (i.e., PLC, OIT, I/O Boards, Power Supplies)
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Installation Qualification (IQ)
Calibration – RANGES FIT FOR USE?G
• Critical Process Devices & Test Equipment
• Calibration for all process devices (Temp, Pressure, etc.)
• Any devices used in execution or measuring data (tachometer, caliper, etc.)
Preventive Maintenance H
• Document all
• Must be scheduled frequency
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Installation Qualification (IQ)
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Spare Parts I
• Critical Spares should be identified
• List of Spare Parts should be available in the Maintenance Shop, and stocked – Fit For Use?
• Product Contact Materials – Fit For Use?
Equipment Procedures J
• Equipment Operation SOPs – Fit For Use?
• Equipment Use Logs
• Cleaning SOPs – Fit For Use?
Installation Qualification (IQ)
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I/O PLC Connectivity K
• All PLC I/Os
• Can be performed by vendor or during SAT
• Can be printed with “Performed by” sign-off/date by vendor
• Empty addresses can be NAP’d
• Simulated or real-time testing
• Simulate signal with software (i.e., force signal in PLC)
• Manipulate field device (obstruct or “make” photo-eye)
• Simulate signal with equipment/instrument (i.e., strobe generator)
• Manipulate using OIT
OPERATIONAL
QUALIFICATION
IQ OQ PQ
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Operation Qualification (OQ)
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Documented verification that all aspects
and functions of a system, facility, utility
or equipment that can affect product
quality operate properly within all
anticipated operating ranges as
required by the process, capability,
procedures and design specification.
Operation Qualification (OQ)
Functional VerificationL
• Challenge the equipment operational ranges
• Vendor operational ranges
• Your Specifications – Fit For Use?
• As wide-range as possible – Fit For Use?
• Based on our equipment requirements – Fit For Use?
• Should be statistical – Fit For Use?
• FAT, SAT, Engineering/Commissioning Studies, testing may satisfy OQ testing requirements and follow GDPs
• FIT FOR INTENDED USE
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Operation Qualification (OQ)
Password Security Verification (if applicable)M• Challenge all system security features
• PLC/OIT Password level challenge (do not record passwords in the protocol)
Safety & Alarm Verification N• Challenge all critical alarms including audible and visual
indicators
• Includes E-Stop / Open Door / Main-line
Controls Verification (if applicable)O• Challenge all controls (could be many pages) – Fit For
Use?
• “Push this button” > This screen appears
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PRACTICE
ACTIVITY
IQ OQ PQ
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Functional Test Example… What would our
functional tests be?
• #1 Filler:
• New filler for moderate-high speed line;
• The filler itself is designed to operate from 20-230
upm (units per minute);
• The remaining line equipment runs 60-110 upm;
• Container sizes are specified to range from 2 ml.
to 200 ml;
• Assume specific gravity of 0.9 for all products.
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Functional Test Example… What would our
functional tests be?
• #1 Filler:
• Challenge product container fill weight
capability
• Run 2 ml bottles at 20 and 230 units per
minute
• Run 200 ml bottles at 20 and 230 units per
minute
• Sample size based on statistics of the lot
size (CpK, etc…)
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Functional Test Example… What would our
functional tests be?
• #2 Mix Vessel:
• New custom designed 12,000L;
• Raw materials are added via tank drop pipe or
through a 30” manway;
• The tank is jacketed;
• Jacket Service hot & cold water and steam;
• A turbine mixer, attached to 40hp electric variable
frequency drive (VFD) motor,
• RPM range of “0”-260 rpm.
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Functional Test Example… What would our
functional tests be?
• #2 Mix Vessel:
• Smallest volume to submerge agitator (min fill
volume)
• Max Volume
• Heating (max temp and temp ramp) Ramp Rate
• Cooling (min temp and max temp ramp) Ramp
Rate
• Agitation – with high and low viscosity products
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VALIDATION
EXECUTION
IQ OQ PQ
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Performance Qualification (PQ)
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Documented verification that all
aspects of a system, facility, utility or
equipment that can affect product
quality produce the required output
over an extended period under
typical operating conditions and
interferences.
Performance Qualification (PQ)
Performance ChallengeP
• Prove the Equipment can work:• For an extended period of time;
• With variety of starts and stops,
• Multiple formulas..
• Challenges equipment / equipment train for extended period under typical operating conditions (to simulate real-world usage)
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DEVIATIONS
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Deviations
• Failure to meet Acceptance Criteria
• Change in testing approach/method
• Equipment does not meet its intended use
Typical Deviations
• Failure / deviation (cite protocol requirements)?
• Investigation
• Corrective Action / Preventative Action
When there is a deviation…
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WRAP UPQuestions & Answers
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