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Equipment Qualification Fit for Intended Use

IVT18th Annual Validation Week

October, 2012

Presented By:


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Agenda

Equipment Qualification TerminologyIntended Use - User RequirementsMaintaining the Qualified State Interactive ExerciseBonus Material

2IVT Validation Week - October, 2012


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Terminology

Risk Assessment- Determines the ability/likely hood that thesubject equipment can impact product quality, efficacy, patientor care provider safety.

Commissioning - The purpose of Commissioning is toestablish confidence that the equipment or system is safe andfunctional and that it meets established requirements and

specifications. For equipment or systems with a direct orindirect 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 changecontrol. For projects where formal FAT, SAT, or Commissioningactivities are not performed, those activities must be completed

during the Qualification phases.



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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 manufacturers 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 andacceptance 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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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 isready for turnover to the customer for acceptance. The extent of testing is agreed with themanufacturer 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 properinstallation and security.

Start up and running with the site utilities to ensure the equipment operates the sameas at the FAT

All required drawings, documents, cut sheets, sequence of operations are complete andappropriate 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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Terminology (cont.)

Installation Qualification Documentation of objective evidenceshowing that the equipment has been installed according to

specifications (manufacturers recommendations)

Operational Qualification - Documentation of objective evidenceshowing that the equipment operates according to specifications (User

Guide, User Requirements)



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Whats 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 andreliably.

Typically done as part of a larger validation effort. May support multiple validation efforts. (see slide #26)

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Getting Started

Validation TeamThe 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, theprotocols 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 Laboratoryo Technical Serviceso Research & Developmento Regulatory Affairs



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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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Intended Use

User Requirements - A stand alone document that iscommon for computer systems. For equipment User

Requirements come from many sources.

Commercial Off The Shelf (COTS) equipment, they usuallytake the form of Owners Manual or Users Guides. Maybe a

Request for Quote (RFI) if the equipment is custom.Other sources:

Set up sheetsDesign of ExperimentParameter Limit Values

Environmental requirements and/or constraintsManufacturers installation guide

Regardless of their origin they form the basis for your Risk

Assessments and Acceptance criteria



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Risk Assessment

CONDUCTING RISK ASSESSMENT

A risk assessment must be performed for all validations anddetermines 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 faultmodes 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 separatedocument.



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EQUIPMENT QUALIFICATIONREQUIREMENTS

The following GAMP V Model (Figure 1) demonstrates the

traceable approach to equipment qualification



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Dont forget the software!

Conducting GxP AssessmentAll 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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Validation Requirements Based on GxPAssessment

Each piece of computerized equipment or computerized systemdetermined as GxP as a result of the GxP assessment is assigned

a criticality per SOP-XYZ based on the use and application of theequipment 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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Category Description Examples Requirements

Non-Computerized Process impact equipment withno computerized component

o Molding toolso Manual Presso Solvent Dispensers

o Product Risk Assessmento Equipment Identificationo Risk based test against process identified

parameters

Non-ConfiguredRun-time parameters may beentered and stored, but the

software cannot be configuredto suit the business process.

o Firmware based applicationso COTS Software/equipmento Instruments

o Abbreviated life cycle approacho Abbreviated (i.e. equipment specifications or

manuals)o Installation Qualification and version controlo Risk-based approach to supplier assessmento Version controlo 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

ConfiguredSoftware that can beconfigured by the user to meet

the specific needs of the usersbusiness/manufacturing

process. Software code is not

altered.

o LIMSo SCADAo Spreadsheetso Simple Human Machine

Interfaces(HMI)Note: specific examples of the above

system types may contain

substantial custom elements.

o Life cycle approacho Risk-based approach to supplier assessmento Demonstrate supplier has an adequate Quality

Management Systemo Some life cycle documentation (DS) retained by

supplier.o Installation Qualification against Design

Qualificationo Operational Qualification against Functional

Specificationo Performance Qualification against .o Version controlo Risk-based testing to demonstrate application

works as designed.o Verify procedures are in place for maintaining

compliance and fitness for intended use

Custom Software custom designed andcoded to suit the businessprocess.

o Internally and externallydeveloped IT applications

o Internally and externallydeveloped process control

applicationsCustom ladder logic

Same as for configurable, plus:oMore rigorous supplier assessment.oPossible supplier auditoPossession of full life cycle documentationoDesign and source code review

Computer System Validation requirements

Some Examples


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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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Installation Qualification

Purpose Scope Equipment descriptiono Boundaries ancillary equipment

Environment Critical Utilities Drawings Preventive Maintenanceo Spare Parts

Product Contacto Cleaning procedureso Materials of construction Product Contact



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Section Requirement/Content

Purpose State the equipment needs to be qualified

Scope State whether the installation is for

o New equipment oro 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

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 andRequirements

Specify the cleaning procedures that must be executed after the equipment is installed 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 EngineeringTurnover 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 ofthe 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 anyIQ

Define the test procedure; IQ testing must be designed to confirm that the equipment is installed in accordancewith manufacturers recommendation or document justification for exceptions

Define the acceptance criteria; for an IQ this is usually a Pass/Fail resultDiscrepancies 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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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 designfeatures that may be considered.



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Operational Qualification (OQ)

User Guides/Manuals Critical Process Parameters Environment Critical Utilities



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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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Section Requirement/Content

Purpose State the equipment needs to be qualified

Scope State whether the installation is foro New equipment oro 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 completedhas 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 bedeferred 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 aseparate 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) Verify the operating ranges and acceptance criteria for each parameterNotes:

Software parameters must also be considered; separate computer validation protocol can be used to address thisRationale and Sampling Locations Provide rationale for:

Qualification approach takenSample size rationaleSelected test conditionsCritical parameters

Testing and Acceptance Criteria Define the test range for each critical process parameter for verificationo The testing range typically brackets the operating range to ensure equipment is qualified with extra security;

e.g., if temperature operating range is 50C to 100C, then the test range should be 40C to 110C

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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Equipment Employed for Multiple Products

When equipment is employed for multiple products, one may consider using

theproven 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 COperating 90 -110 85 - 100 100 - 120

Control 85 - 115 80 - 105 105 - 125Proven Acceptable 80 - 120 75 - 110 100 - 130


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Maintaining the Qualified State

Training Preventive Maintenanceo Spare Parts List

Calibration Change Control Re-Qualification



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Re-Qualification

Re-Qualification Review

The validation status of qualified equipment must bereviewed to determine whether it continues to operate in a

qualified state. With the exception of those processes that

are subject to regulatory requirements regarding timespecific 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 validationassessment 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


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Documentation Strategies


IOQ

IQ OQ


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Interactive Stuff

Participants develop an equipment qualification protocol



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BONUS Material

Mold Validation Procedure Forms

Production Equipment and Process validation ProcedureGxP Assessment Procedure


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