Main Banner

Qualifications and Validations

Independent Quality Consultants (IQC) provides a full range of consulting services including Process validations and IQ/OQ/PQ at very competitive rate. Our consulting services ensures that projects are initially performed correctly and that FDA requirements are fully satisfied.

Verification, Validation, Qualification: Design, Product, Process, Tester

Qualification (Equipment)

  • Assuring through inspection, testing and documentation that:
    • The correct equipment has been installed, meeting installation requirements
    • The equipment per forms according to preestablished written specifications

Verification (Design)

  • Accepted definition from USFDA: “establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.

Validation (Process or Method)

  • Accepted definition from USFDA:“establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
  • Validation applies to processes or analytical Methods. Validation of an analytical method must always be performed on qualified equipment to ensure that the method will work with similar equipment.Method validation provides assurance that the method produces accurate results under a range of conditions that includes using other equipment that also satisfies the DQ specifications

Definitions for the Qs

  • Design Qualification(DQ) provides a set of user specifications set forth to ensure that the appropriate instrument is chosen for the intended use.
  • Installation Qualification (IQ) verifies that the specified equipment was installed correctly.
  • Operational Qualification (OQ) verifies that the equipment is operating according to
    specifications.
  • Both IQ and OQ are required for new equipment or equipment that has been redesigned or relocated.
  • PQ is often referred to as Performance Qualification in the process world;showing that the equipment will perform as required, i.e.
    temperature ranges,etc.
  • Re-qualification (RQ) including risk and impact of assessment of changes to perform proper validation testing.

PPQ

  • The PPQ combines the actual facility, utilities, equipment (each now qualified), and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches. https://www.fda.gov/media/71021/download
  • Calibrations in validations are performed with NIST traceable standards. Equipment gauges calibration are verified during validation.

Validate or Qualify

  • Analytical methods must be validated.
  • Processes must be validated.
  • Process Control Systems must be validated.
  • Data systems must be validated (the application performs one or more processes).
  • All regulated equipment must be qualified.

In Summary

  • For process, IQ/OQ/PQ demonstrates that the equipment is installed correctly,is functioning to specifications and meets the demands of the process.
  • Validation proves that a process produces a product that is consistent with predetermined requirements
  • or that an analytical method is robust and will performs required using qualified equipment.