Qualification

 Qualification in the pharmaceutical industry refers to the process of demonstrating that equipment, facilities, utilities, and systems are suitable for their intended use and meet pre-established requirements. Qualification is a critical aspect of ensuring that pharmaceutical products are of high quality and meet regulatory requirements.

Qualification typically includes three stages:

  1. Design Qualification (DQ): This stage involves verifying that the design of the equipment or system meets the user's requirements and regulatory standards.

  2. Installation Qualification (IQ): This stage involves verifying that the equipment or system has been installed correctly and meets the manufacturer's specifications.

  3. Operational Qualification (OQ): This stage involves verifying that the equipment or system operates consistently within its defined operating ranges and that it produces the desired results.

In addition to these three stages, some equipment and systems may require a fourth stage, called Performance Qualification (PQ), which involves demonstrating that the equipment or system consistently performs as intended over a sustained period of time.

Qualification is typically performed by a cross-functional team, including representatives from engineering, quality, and operations. Qualification protocols are developed to outline the testing and acceptance criteria for each stage, and the results of the testing are documented in a qualification report.

Qualification is an ongoing process, and equipment, facilities, utilities, and systems must be periodically re-qualified to ensure that they continue to meet their intended use and regulatory requirements.

  • Prior to proceeding for process validation, qualification of equipment and its ancillary systems should be completed including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
  • Design Qualification (DQ): Documented objective evidence that the proposed design of the facilities, equipment, and its ancillary systems is suitable for the intended use.
  • Installation Qualification (IQ): Documented objective evidence that the equipment and its ancillary systems, comply with the approved design, manufacturer’s recommendations, and User Requirement Specifications (URS).
  • Operational Qualification (OQ): Objective documented evidence that the equipment and its ancillary systems, perform as intended throughout the required operating range.
  • Performance Qualification (PQ): Objective documented evidence that the equipment and its ancillary systems together can per

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