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Equipment qualification

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  • 1. Equipment Qualification – Fit for Intended Use IVT 18th Annual Validation Week™ October, 2012Presented 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. IVT Validation Week - October, 2012 3
  • 4. Terminology (cont.) •  Factory Acceptance Test (FAT)The purpose of FAT is to establish confidence that the equipment or system is tested to theextent possible at the manufacturer’s facility and that it is ready for shipment and installationat the operational site. The extent of testing is agreed with the manufacturer in advance andis 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. IVT Validation Week - October, 2012 4
  • 5. Terminology (cont.) •  Site Acceptance Test (SAT)The purpose of SAT is to establish confidence that the equipment or system has been built to designspecifications, 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 approvedthe 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. IVT Validation Week - October, 2012 5
  • 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) IVT Validation Week - October, 2012 6
  • 7. What’s the difference between Validation andQualification?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 (manufacturers 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) IVT Validation Week - October, 2012 7
  • 8. Getting StartedValidation 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, 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 IVT Validation Week - October, 2012 8
  • 9. Getting StartedFor 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. IVT Validation Week - October, 2012 9
  • 10. Intended UseUser Requirements - A stand alone document that iscommon for computer systems. For equipment UserRequirements come from many sources. Commercial Off The Shelf (COTS) equipment, they usuallytake the form of Owners’ Manual or Users’ Guides. Maybe aRequest 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 guideRegardless of their origin they form the basis for your RiskAssessments and Acceptance criteria IVT Validation Week - October, 2011 10
  • 11. Risk AssessmentCONDUCTING RISK ASSESSMENTA risk assessment must be performed for all validations anddetermines the documentation deliverables.The risk assessment will determine the validation parameters of theoverall 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 isappropriate and to gauge the relative level of validation testing andneed for external safeguards.Risk assessment must be conducted using methods appropriate tothe scope and nature of the validation project.The conclusions of the risk assessment process may be included ina project Validation Plan, in individual protocols, or in a separatedocument. IVT Validation Week - October, 2012 11
  • 12. EQUIPMENT QUALIFICATIONREQUIREMENTSThe following GAMP V Model (Figure 1) demonstrates the traceable approach to equipment qualification IVT Validation Week - October, 2012 12
  • 13. Don’t 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. IVT Validation Week - October, 2012 13
  • 14. Validation Requirements Based on GxP AssessmentEach piece of computerized equipment or computerized systemdetermined as GxP as a result of the GxP assessment is assigneda criticality per SOP-XYZ based on the use and application of theequipment with rationale.Equipment criticality is assessed by performing risk assessmentdirectly on equipment or through process and/or product. All equipment systems determined as GxP related are categorizedas Non-configured, Configured, or Custom. IVT Validation Week - October, 2012 14
  • 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 IdentificationNon-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 IVT Validation Week - October, 2011 15
  • 16. Installation Qualification (IQ)The purpose of the IQ is to establish by objective evidencethat the equipment as installed or modified. For equipmentqualifications, an IQ should contain these minimumrequirements. IVT Validation Week - October, 2012 16
  • 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 IVT Validation Week - October, 2012 17
  • 18. Installation Qualification (IQ) Requirement/Content SectionPurpose State the equipment needs to be qualifiedScope State whether the installation is for o  New equipment or o  Modifying previous qualified equipmentEquipment/ Describe what the equipment does, how it is used, what process/products use it, and its basic design featuresSystem DescriptionSupplier Vendor certification and safety feature verificationEquipment 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 appropriateUtilities Utilities required to operate the equipment should be identifiedConstruction, Installation and •  Specify the cleaning procedures that must be executed after the equipment is installedRequirements •  Document that the cleaning procedures have been successfully executed and completedSupporting Documentation •  List supporting documentation that may be used to identify or operate the equipment such as Engineering Turnover Packages, Purchase Orders, or Equipment ManualsMaintenance Programs •  Establish maintenance procedure •  Include a listing of any preventive maintenance activitiesSpare/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 referenceDrawings List and include in the qualification protocol for the system drawings used to support the IQTesting 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 resultDiscrepancies Discuss and justifies events per required deviation or exception procedureSummary and Conclusion •  Summarize IQ test results, which demonstrate that the equipment was installed correctly •  Provide a conclusion on whether the equipment installation is acceptable IVT Validation Week - October, 2012 18
  • 19. Installation Qualification (IQ)The IQ will document that the required design feature havebeen properly installed. The number of design features canvary from a few to any number of design features. Designfeatures are dependent upon the complexity of theequipment.The following slide contains examples of various designfeatures that may be considered. IVT Validation Week - October, 2011 19
  • 20. Installation Qualification (IQ) Category Design FeaturesEquipment •  Product contact materials of construction •  Labeling (marking/identification)Process Piping •  Material of construction •  Size •  Pressure test •  InsulationEnvironment •  Temperature •  Humidity •  Particulates (viable and/or non-viable)Valves •  Valve type •  Size •  Actuator typeLubricants •  Lubricant description Commodity number •  •  Stock number •  Whether the lubricant has direct or incidental product contactSafety 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 criteriaInstrumentation •  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 programUtilities •  Compressed gas connections •  Sample ports (if required), labeling and sizes IVT Validation Week - October, 2011 20
  • 21. Operational Qualification (OQ)•  User Guides/Manuals•  Critical Process Parameters•  Environment•  Critical Utilities IVT Validation Week - October, 2012 21
  • 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. IVT Validation Week - October, 2012 22
  • 23. Operational Qualification (OQ) Section Requirement/ContentPurpose State the equipment needs to be qualifiedScope State whether the installation is for o  New equipment or o  Modifying previous qualified equipmentEquipment/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 acceptableOperational 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 beginTest 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 dateStandard 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 completedAlarm/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 equipmentOperating 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 thisRationale and Sampling Locations Provide rationale for: • Qualification approach taken • Sample size rationale • Selected test conditions • Critical parametersTesting 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 equipmentTest Result Documentation Summarize test results and confirms the acceptance criteriaDiscrepancies Discuss and justifies discrepanciesSummary and Conclusion Summarize equipment OQ results and provide a conclusion on whether the equipment operation is acceptable IVT Validation Week - October, 2012 23
  • 24. Operational Qualification (OQ)Equipment Employed for Multiple ProductsWhen 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° IVT Validation Week - October, 2012 24
  • 25. Maintaining the Qualified State•  Training•  Preventive Maintenance o  Spare Parts List•  Calibration•  Change Control•  Re-Qualification IVT Validation Week - October, 2012 25
  • 26. Re-QualificationRe-Qualification ReviewThe 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 StuffParticipants 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