Equipment Qualification Fit for Intended Use

IVT
18th Annual Validation Week October, 2012
Presented By:

Agenda
Equipment Qualification Terminology Intended Use - User Requirements Maintaining the Qualified State Interactive Exercise Bonus Material

IVT Validation Week - October, 2012

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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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 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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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. IVT Validation Week - October, 2012 5

Terminology (cont.)

Installation Qualification Documentation of objective evidence

showing that the equipment has been installed according to specifications (manufacturers recommendations)

Operational Qualification - Documentation of objective evidence

showing that the equipment operates according to specifications (User Guide, User Requirements)

IVT Validation Week - October, 2012

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 and reliably. Typically done as part of a larger validation effort. May support multiple validation efforts. (see slide #26)
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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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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 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 Manufacturers 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 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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EQUIPMENT QUALIFICATION REQUIREMENTS

The following GAMP V Model (Figure 1) demonstrates the traceable approach to equipment qualification

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Dont 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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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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Computer System Validation requirements Some Examples

Category Description o Process impact equipment with o no computerized component o o o o Run-time parameters may be entered and stored, but the software cannot be configured to suit the business process. Examples Molding tools Manual Press Solvent Dispensers Firmware based applications COTS Software/equipment Instruments o o o o o o o o o o LIMS SCADA Spreadsheets Simple Human Machine Interfaces(HMI) Software that can be Note: specific examples of the above configured by the user to meet system types may contain the specific needs of the users substantial custom elements. business/manufacturing process. Software code is not altered. o o o o o o o Requirements Product Risk Assessment Equipment Identification Risk based test against process identified parameters Abbreviated life cycle approach Abbreviated (i.e. equipment specifications or manuals) Installation Qualification and version control Risk-based approach to supplier assessment Version control Risk-based test against (for simple systems regular calibration may substitute for testing) Verify procedures are in place for maintaining compliance and fitness for intended use Non-Computerized

Non-Configured

Configured

Custom

Software custom designed and coded to suit the business process.

Internally and externally developed IT applications o Internally and externally developed process control applications Custom ladder logic o

Life cycle approach Risk-based approach to supplier assessment Demonstrate supplier has an adequate Quality Management System o Some life cycle documentation (DS) retained by supplier. o Installation Qualification against Design Qualification o Operational Qualification against Functional Specification 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 Same as for configurable, plus: oMore rigorous supplier assessment. oPossible supplier audit oPossession of full life cycle documentation oDesign and source code review

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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 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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Installation Qualification (IQ)

Requirement/Content State the equipment needs to be qualified State whether the installation is for o New equipment or o Modifying previous qualified equipment Describe what the equipment does, how it is used, what process/products use it, and its basic design features Vendor certification and safety feature verification 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 required to operate the equipment should be identified Specify the cleaning procedures that must be executed after the equipment is installed Document that the cleaning procedures have been successfully executed and completed List supporting documentation that may be used to identify or operate the equipment such as Engineering Turnover Packages, Purchase Orders, or Equipment Manuals Establish maintenance procedure Include a listing of any preventive maintenance activities 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 List and include in the qualification protocol for the system drawings used to support the IQ 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 Discuss and justifies events per required deviation or exception procedure Summarize IQ test results, which demonstrate that the equipment was installed correctly Provide a conclusion on whether the equipment installation is acceptable

Section Purpose Scope

Equipment/ System Description Supplier Equipment Components

Utilities Construction, Installation and Requirements Supporting Documentation Maintenance Programs Spare/Change Parts Drawings

Testing and Acceptance Criteria

Discrepancies Summary and Conclusion

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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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Installation Qualification (IQ)

Category Equipment Process Piping Design Features Product contact materials of construction Labeling (marking/identification) Material of construction Size Pressure test Insulation Temperature Humidity Particulates (viable and/or non-viable) Valve type Size Actuator type Lubricant description Commodity number Stock number Whether the lubricant has direct or incidental product contact Device type Product contact surface material Pressure and temperature rating (if applicable) Description of the alarm and whether they are Operational or Quality in nature Acceptance criteria

Environment

Valves

Lubricants

Safety Devices

Alarms 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 Compressed gas connections Sample ports (if required), labeling and sizes

Utilities

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Operational Qualification (OQ)

User Guides/Manuals Critical Process Parameters Environment Critical Utilities

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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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Operational Qualification (OQ)

Section Purpose Scope Requirement/Content State the equipment needs to be qualified State whether the installation is for o New equipment or o Modifying previous qualified equipment 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 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 Operating Parameters A completed record of qualified test equipment and approved materials that is used during protocol execution List calibration date and next due date 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 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 Verify the key and critical process parameters (some equipment may not have critical process parameters) Verify the operating ranges and acceptance criteria for each parameter

Equipment/System Description Operational Qualification Pre-requisites Test Equipment Calibration Verification Standard Operating Procedures Alarm/Control Challenges

Notes: Software parameters must also be considered; separate computer validation protocol can be used to address this

Rationale and Sampling Locations

Testing and Acceptance Criteria

Provide rationale for: Qualification approach taken Sample size rationale Selected test conditions Critical parameters 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 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 Discrepancies Summary and Conclusion

Summarize test results and confirms the acceptance criteria Discuss and justifies discrepancies Summarize equipment OQ results and provide a conclusion on whether the equipment operation is acceptable

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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 Product A limits. Product B Product C
Operating Control Proven Acceptable 90 -110 85 - 115 80 - 120 85 - 100 80 - 105 75 - 110 100 - 120 105 - 125 100 - 130

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Maintaining the Qualified State

Training Preventive Maintenance o Spare Parts List Calibration Change Control Re-Qualification

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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 requalification. IVT Validation Week - October, 2012

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Documentation Strategies

IQ

OQ IOQ

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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 Procedure GxP Assessment Procedure

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