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Qualification & Validation of Equipment, Systems, Utilities in Pharmaceuticals

Qualification & Validation of Equipment

Equipment qualification as required by the FDA requires verification documentation to start with the Validation Master Plan (VMP) and flow through a series of documents that define the scope and tasks required to successfully execute your equipment qualification task.

The VMP dictates the actions that all persons involved in equipment qualification projects must comply with. The Equipment Validation Plan (VP) may often be designed to include more than one piece of equipment.

The VMP is not mandated by the FDA but is always asked for in regulatory reviews and inspections.

What is the Qualification?

Qualification is defined as an act of providing that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results. Qualification is part of the validation, but the individual qualification steps alone do not constitute process validation.

Qualification and validation protocols

There should be qualification and validation protocols describing the qualification and validation study to be performed.

As a minimum the protocols should include the following significant background information:

  • The objectives of the study
  • The site of the study
  • The responsible personnel
  • Description of SOPs to be followed
  • Equipment to be used; standards and criteria for the relevant products and processes
  • The types of validation
  • The processes and/or parameters
  • Sampling, testing, and monitoring requirements
  • Predetermined acceptance criteria for drawing conclusions.

There should be a description of the way in which the results will be analyzed.

The protocol should be approved prior to use. Any changes to a protocol should be approved prior to the implementation of the change.

Stage or Component of Qualification

  • User Requirement Specification (URS)
  • Design qualification (DQ)
  • Factory acceptance test (FAT)
  • Site Acceptance Test (SAT)
  • Installation qualification (IQ)
  • Operational qualification (OQ)
  • performance qualification (PQ)
  • Re-Qualification (RQ)

All SOPs for operation, maintenance, and calibration should be prepared during qualification.

Training should be provided to operators and training records should be maintained.


  • URS should be prepared for systems, utilities, and equipment, where appropriate
  • URS should be used to verify, at a later stage, that the purchased and supplied system, utility or equipment is in accordance with the manufacturer’s needs as specified.

Design qualification (DQ)

  • Design qualification should provide documented evidence that the design specifications were met.
  • URS should be considered when deciding on the specific design of a system, utility, or equipment.
  • A suitable supplier should be selected for the appropriate system, utility, or equipment
  • The supplier should be approved prior to purchasing the system, utility, or equipment
  • On delivery of the system, utility, or equipment, the user should verify that it meets the agreed design specifications and satisfies the URS
  • Once DQ is completed, IQ may commence.


  • Where a system, utility, or equipment is assembled, or partially assembled at a site other than that of the purchaser or end-user, testing and verification should be done to ensure that the system, utility, or equipment is appropriate and ready for dispatch.
  • The checks and tests during assembly or partial assemble, should be recorded.
  • The acceptability of the assembly and overall status of the system, utility, or equipment should be described in a conclusion of the report for the factory acceptance test (FAT), prior to shipment.
  • When the system, utility, or equipment is received at the end-user, tests should be performed to verify the acceptability of the system, utility, or equipment.
  • The results of the tests should be recorded and the outcome of the acceptability of the system, utility, or equipment recorded in the conclusion of the report for the site acceptance test (SAT).

Installation Qualification (IQ)

The performance of tests to ensure that the installations (such as machines, measuring devices, utilities, and manufacturing areas) used in a manufacturing process are appropriately selected and correctly installed and operate in accordance with established specifications.

Installation qualification should provide documented evidence that the installation was complete and satisfactory.
The purchase specifications, drawings, manuals, spare parts lists, and vendor details should be verified during installation qualification. Control and measuring devices should be calibrated.

Newly installed or modified equipment must first be validated to determine if it’s capable of producing the desired results through Design Qualification (DQ)—a protocol defined as the documented verification of a proposed design’s ability to meet the requirements it needs to fulfill.

. Installation Qualification (IQ) verifies that an instrument or unit of equipment being qualified (as well as its sub-systems and any ancillary systems) has been installed and configured according to the manufacturer’s specifications or installation checklist.

For example, a physical instrument or tool may require a specific amount of floor space, certain operating conditions, and an assurance that no damage exists on the unit. For software, IQ typically involves (but is in no way limited to) verifying folder structures are correctly established and ensuring that the minimum system requirements are met.

Regardless of whether it’s a physical unit or software being tested, the FDA’s IQ definition offers a useful statement of the overall goal: documenting that the “system has the necessary prerequisite conditions to function as expected.”

Along with this, any CGMP requirements relevant to the IQ—and the methodology used for IQ—must be documented thoroughly in the Validation Master Plan (VMP).

After the initial IQ, re-qualification must be performed following any major maintenance or when equipment is modified. Re-qualification should also be performed as part of routine quality assurance processes.

What makes IQ successful?

Successful IQ is typically measured by how well the installation process followed the manufacturer’s guidelines and met their requirements.

This often includes (but is not limited to) the following areas of focus:

  •  Location of install and necessary floor space
  • Documentation of any and all computer-controlled instrumentation
  • Gathering all manuals and certifications
  • Properly unpacking and cross-checking instruments
  • Examining instruments and components for damage
  • Ensuring correct power supply
  • Installing ancillary instruments
  • Documenting firmware versions and serial numbers
  • Environmental and operating conditions
  • Checking software system installation and accessibility
  • Recording calibration and validation dates of tools used for IQ
  • Verifying connections and communication with peripheral units

Operational Qualification (OQ)

  • Documented verification that the system or subsystem performs as intended overall anticipated operating ranges.
  • Operational qualification should provide documented evidence that utilities, systems or equipment, and all its components operate in accordance with operational specifications.
  • Tests should be designed to demonstrate satisfactory operation over the normal operating range as well as at the limits of its operating conditions (including worst-case conditions).
  • Operation controls, alarms, switches, displays, and other operational components should be tested.
  • Measurements made in accordance with a statistical approach should be fully described.

Operational qualification (OQ) is performed after meeting each protocol of IQ. OQ’s purpose is to determine that equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges. In action, this means identifying and inspecting equipment features that can impact final product quality.

During OQ, all items in the test plan are tested and their performance is thoroughly documented. Since this is a prerequisite for acceptance of equipment and the facility, it can only be conducted once the IQ is run.


In general, OQ serves as a detailed review of hardware or software startup, operation, maintenance, cleaning, and safety procedures (if and where they’re applicable). Every unit of hardware and software must be shown to be operating within the specified limits.

What makes OQ successful?

As we explained above, the action items of OQ are identifying and inspecting the components of equipment that impact product quality and ensuring they’re operating within specific limits.

These often include (but, again, are no way limited to) the following:

  • Temperature control and variations
  • Servo motors and air flaps
  • Temperature protection systems
  • Card readers and access systems
  • Pressure and vacuum controllers
  • Temperature distribution
  • Display units and signaling LEDs
  • CO2 controls
  • Humidity-measuring and control
  • Fan and fan-speed controllers

Performance Qualification (PQ)

  • Documented verification that the equipment or system operates consistently and gives reproducibility within defined specifications and parameters for prolonged periods. (In the context of systems, the term “process validation” may also be used.)
  • Performance qualification should provide documented evidence that utilities, systems, or equipment, and all its components can consistently perform in accordance with the specifications under routine use.
  • Test results should be collected over a suitable period of time to prove consistency

The final step of qualifying equipment is PQ. In this phase, the qualification and validation team verifies and documents that the equipment is working with reproducible results within a specific working range in simulated real-world conditions.

Instead of testing components and instruments one-by-one, PQ tests them all as a partial or overall process.

Before they start qualifying, however, the team must create a detailed test plan based on the process description. It’s important to note that the quality of the qualification depends in large part on the quality of the test plan. This is one area where a third-party specialist can (and often should) be brought in to ensure thoroughness and accuracy.

The Process Performance Qualification (PPQ) protocol is a fundamental component of process validation and qualification. Its purpose is to ensure ongoing product quality by documenting performance over a period of time for certain processes.

FDA Criteria for PQ and PPQ Protocols

In its guidance, “Process Validation: General Principles and Practices,” the FDA officially defines the PQ stage into its two elements:

  1. Design of the facility and qualification of the equipment and utilities
  2. Process Performance Qualification (PPQ)

During the second stage, the FDA states in its guidance that “CGMP-complaint procedures must be followed,” adding that “successful completion of Stage 2 is necessary before commercial distribution.”

The FDA guidance recommends including the following elements as part of PQ and PPQ protocols:

  • Manufacturing conditions such as equipment limits, operating parameters, and component inputs
  • A thorough list of the data that should be recorded or analyzed during tests, calibration, and validation
  • Tests to ensure consistent quality throughout the production
  • A sampling plan detailing the sampling methods used during and in between production batches
  • Analysis methodology for making data, scientific and risk-oriented decisions based on statistical data
  • Definitions for variability limits and contingency plans for handling non-conformance
  • Approval of the PPQ protocol by relevant departments—namely the Quality Unit.


  • Re-qualification should be done in accordance with a defined schedule.
  • The frequency of requalification may be determined on the basis of factors such as the analysis of results relating to calibration, verification, and maintenance.
  • There should be periodic requalification, as well as requalification after changes (such as changes to utilities, systems, equipment; maintenance work; and movement).
  • Requalification should be considered as part of the change control procedure.

Qualification reports

  • There should be written reports on the qualification and validation performed.
  • Reports should reflect the protocols followed and include at least the title and objective of the study; reference to the protocol; details of material, equipment, programs, and cycles used; procedures and test methods.
  • The results should be evaluated, analyzed, and compared against the pre-determined acceptance criteria. The results should meet the acceptance criteria; deviations and out-of-limit results should be investigated. If these deviations are accepted, this should be justified. Where necessary further studies should be performed.
  • The departments responsible for the qualification and validation work should approve the completed report.
    The conclusion of the report should state whether or not the outcome of the qualification and/or validation was considered successful.
  • The quality assurance department should approve the report after the final review. The criteria for approval should be in accordance with the company’s quality assurance system.
  • Any deviations found during the validation process should be acted upon and documented as such. Corrective actions may be required.



About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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