equipment qualification

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

2 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.


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.


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.


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)


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)

IVT Validation Week - October, 2012 7

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


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.


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 IVT Validation Week - October, 2011 10

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.


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


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.


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.



Category Description Examples Requirements

Non-Computerized Process impact equipment with no computerized component

o  Molding tools o  Manual Press o  Solvent Dispensers

o  Product Risk Assessment o  Equipment Identification o  Risk based test against process identified

parameters

Non-Configured

Run-time parameters may be entered and stored, but the software cannot be configured to suit the business process.

o  Firmware –based applications o  COTS Software/equipment o  Instruments

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

manuals) o  Installation Qualification and version control o  Risk-based approach to supplier assessment o  Version control 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

Configured

Software that can be configured by the user to meet the specific needs of the user’s business/manufacturing process. Software code is not altered.

o  LIMS o  SCADA o  Spreadsheets o  Simple Human Machine

Interfaces(HMI) Note: specific examples of the above

system types may contain substantial custom elements.

o  Life cycle approach o  Risk-based approach to supplier assessment o  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

Custom Software custom designed and coded to suit the business process.

o  Internally and externally developed IT applications

o  Internally and externally developed process control applications

Custom ladder logic

Same as for configurable, plus: o More rigorous supplier assessment. o Possible supplier audit o Possession of full life cycle documentation o Design and source code review

Computer System Validation requirements Some Examples

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.


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



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

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 Requirements

•  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 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



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.



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


Operational Qualification (OQ)

•  User Guides/Manuals •  Critical Process Parameters •  Environment •  Critical Utilities



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.



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) •  Verify the operating ranges and acceptance criteria for each parameter Notes: •  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



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°

Maintaining the Qualified State

•  Training •  Preventive Maintenance o  Spare Parts List

•  Calibration •  Change Control •  Re-Qualification


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.


Documentation Strategies


IOQ

IQ OQ

Interactive Stuff

Participants develop an equipment qualification protocol


BONUS Material

• Mold Validation Procedure •  Forms

• Production Equipment and Process validation Procedure

• GxP Assessment Procedure


equipment qualification

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