Validation & Qualification

Ensuring the compliance and performance of critical equipment involves a meticulous qualification process. Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) verify construction, installation, and functionality. Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Process Performance Qualification (PQ) play crucial roles in confirming compliance with user requirements, GMP guidelines, and functional specifications. Let’s explore each stage’s significance in assuring the reliability of the system.

Woman in a suit checking the performance of a machine on a tablet.

Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)

The purpose of these tests is to ensure that the most critical equipment of the system or specific components meet the design requirements and the user-established requirements in the factory environment (FAT) initially and in the plant environment (SAT).

FAT/SAT protocols are part of the system commissioning documentation.

As part of this preliminary check, the proper construction and installation of the system are verified according to the detailed design, specified materials, and construction standards, as well as other regulatory requirements. Furthermore, to ensure that the system, as constructed, operates according to design criteria, necessary functional and performance tests will also be conducted.

Design Qualification (DQ)

The design qualification protocol verifies that the system design has been carried out according to user requirements for product quality and GMP. In this stage, user requirements regarding equipment design documentation are thoroughly checked.

Installation Qualification (IQ)

The goal of installation qualification is to ensure that the installed equipment/system or the installation itself complies with the supplier’s recommendations, as well as the description of design specifications. It is verified that it is well-documented in all relevant aspects and installed according to GMP guidelines. IQ will include supplier tests and specific tests based on risk analysis results.

Operational Qualification (OQ)

The objective of operational qualification is to verify that the operating parameters of the equipment/system comply with functional specifications and acceptance criteria in each case, according to established test conditions, including limit conditions. It will be based on critical quality attributes (CQAs) and critical process parameters (CPPs) identified in the previous stages of qualification, as well as critical aspects (CAs) or risk control measures derived from risk analysis.

Process Performance Qualification (PQ)

The goal of process performance qualification is to verify that the operating parameters of the equipment/system comply with functional specifications covering the intended process operating range.