6 Steps to Compliant Equipment Qualification

The US Food and Drug Administration does not define qualification. Considered a subset of validation, it is typically performed as a larger validation effort or in support of such. Equipment qualification will provide 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. Taken from a presentation at IVT’s Validation Week, the following are the six steps to a compliant equipment qualification.

1. Assemble the Validation Team

A multi-functional team, led by a project leader, should be established to plan and oversee the validation activities. A team approach to will guarantee the validation processes are well thought out, the protocols are comprehensive, and that the final packages are well documented and easy to follow. The team members should include quality assurance, engineering, and manufacturing. Depending on the facility organization and the equipment/product type, employees working in the laboratory, technical services, research and development, and regulatory affairs could also be part of the validation team.

For all phases of the equipment qualification, the project team must:

  • Determine what, how, and when to verify/measure key metrics including the statistical significance.
  • Define acceptance/rejection criteria.
  • Identify required documentation.
  • Identify the division of responsibilities and activities. The team must determine this based on the risk assessment to provide a high degree of assurance that the equipment under test is suitable for its intended purpose.

2. What are the Intended Use/User Requirements?

What the intended use for the equipment must be clearly defined. For computer systems, this will come from the user requirements document. The user requirements document is a standalone document that is common for computer systems. For other equipment, the user requirements will come from other sources. With commercial-off-the-shelf (COTS) equipment, they usually take the form of Owners’ Manual or Users’ Guides. If the equipment is custom made, a request for quote (RFI) can be a potential source. 

Other common sources include design of experiment/parameter limit values set up sheets, environmental requirements or constraints, and the manufacturers’ installation guide. 

The user requirements will form the basis for risk assessments and acceptance criteria.

3. Conduct a Risk Assessment

A risk assessment must be performed for all validations. As such, it will determine the documentation deliverables. The risk assessment will determine the validation parameters of the overall equipment or system and the required functions.  

The assessment, by using methods appropriate to the scope and nature of the validation project, must 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.  

The conclusions of the risk assessment process may be included in a project validation plan, in individual protocols, or in a separate document.

4. Installation Qualification

The purpose of the IQ is to establish by objective evidence that the equipment as installed or modified according to specifications.

For equipment qualification, the requirements for installation qualification follow in Table I.

Table I: Installation Qualification Sections and Requirements

Section Requirement/Content
Purpose State the equipment needs to be qualified
Scope State whether the installation is for new equipment or 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 extremely. Design features are dependent upon the complexity of the equipment.

Table II contains examples of various design features that may be considered.

Table II: Installation Qualification Design Features

Design Features
Product contact materials of construction
Labeling (marking/identification)
Process Piping
Material of construction
Pressure test
Particulates (viable and/or non-viable)
Valve type
Actuator type
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)
Description of the alarm and whether they are Operational or Quality in nature
Acceptance criteria
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

5. Operational Qualification

Operational qualification is the documentation of objective evidence showing that the equipment operates according to specifications. OQ, at the very least, must include and/or address the items in Table III. Statistical tools such as design experiment and/or response surface design should be applied to optimize equipment and process performance.

Table III: Operational Qualification Sections and Requirements

State the equipment needs to be qualified
State whether the installation is for new equipment or 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 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
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 the goal of process validation. The function of PAR is to include and validate all corresponding control and operating ranges at the same time. Table IV is an example of equipment that employing three products or molds of which temperature is one of the critical process control variables.

Table IV: Equipment that Employs Three Products or Molds of Which Temperature is One of the Critical Process Control Variables.

  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°

The objective to challenge the operating range should test on the lowest and highest proven acceptable limits.  

6. Requalification 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 requalification 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.   

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