Qualification Step of Equipment, Facilities, Utilities

Qualification Stages for Equipment, Facilities, Utilities and Systems
 User Requirement Specification (URS)
The specification for equipment, facilities, utilities or systems should be defined in a URS and/or
a functional specification. The essential elements of quality need to be built in at this stage and
any GMP risks mitigated to an acceptable level.
 What is Design Qualification (DQ)?
Design Qualification (DQ) is the documented verification process that ensures the design of
equipment or systems meets the required specifications and operational requirements. It is
typically the first stage of the equipment qualification process and serves as the foundation for
the later stages, which include Installation Qualification (IQ), Operational Qualification (OQ),
and Performance Qualification (PQ).
 Design Qualification Process
The Design Qualification (DQ) process involves several key steps to ensure that equipment is
suitable for its intended use in pharmaceutical manufacturing. This process is typically carried
out in collaboration with the equipment supplier and the client’s engineering and quality teams.
The steps are as follows:

1. Define User Requirements Specifications (URS)
The process begins with the development of a User Requirements Specification (URS). This
document outlines what the equipment is expected to do, the operating conditions, and
performance criteria. The URS provides a detailed description of the equipment’s intended use,
including:
 Product specifications
 Environmental requirements
 Operational and maintenance expectations
 Safety and regulatory compliance needs
2. Supplier Evaluation and Selection:
After defining the URS, the next step is selecting an equipment supplier that can meet these
requirements. During this stage, potential suppliers are evaluated based on their ability to
design and manufacture equipment that adheres to the specifications. Supplier audits and
evaluations are typically performed to ensure quality and reliability.
3. Review of Equipment Design

Once a supplier is selected, the actual design of the equipment is reviewed. This involves an
evaluation of the proposed equipment to ensure it meets the requirements set forth in the URS.
Critical design aspects, such as materials, dimensions, controls, safety features, and software
integration, are carefully reviewed to confirm that the equipment is appropriate for the intended
application.
4. Risk Assessment:
A risk assessment is conducted to identify any potential issues with the equipment’s design. The
risk assessment helps ensure that any design flaws or potential operational risks are identified
and addressed before the equipment is manufactured and installed.
5. Final Design Approval
After the risk assessment and any necessary adjustments, the final design is approved. This stage
ensures that the equipment is ready for production and that it will meet all operational, regulatory,
and safety requirements when installed.
 Factory Acceptance Testing (FAT)
Factory Acceptance Testing (FAT) is a process performed at the manufacturer’s facility to ensure
that the equipment being purchased or custom-built for a pharmaceutical company operates
according to its design specifications before it is shipped. FAT is a comprehensive inspection and
testing procedure conducted in a controlled environment, usually witnessed by both the vendor
and the client, to verify that the equipment functions correctly under factory conditions. During
FAT, all aspects of the equipment are thoroughly tested, including mechanical, electrical, and
software components. FAT serves as a final quality check to confirm that the equipment performs
as expected before it leaves the manufacturer’s premises. If any issues arise during FAT, they can
be addressed immediately by the manufacturer, minimizing the risk of problems once the
equipment reaches the client’s site.
 Verification of design specifications

 Functional testing of the equipment
 Software testing and integration with other systems
 Verification of operational safety and adherence to regulatory requirements
 What is SAT?
Site Acceptance Testing (SAT) is the next stage of equipment validation and is conducted at the
client’s site after the equipment has been installed. The goal of SAT is to verify that the equipment
functions correctly once installed, connected, and integrated with other equipment and systems in
the production facility. It also confirms that the installation was completed correctly and that the
equipment meets all predefined requirements, including those identified during the Factory
Acceptance Test (FAT).
 What Are the Differences Between FAT and SAT?
Conducted at the manufacturer’s facility, Conducted at the client’s site, after the
typically in a controlled environment equipment has been delivered and
Location:
where the equipment is built or installed.
assembled.
Focuses on ensuring that the equipment Focuses on verifying that the equipment
functions as per design specifications and integrates properly with other systems and
Purpose:
passes all functional and safety tests performs correctly under actual operating
before shipment. conditions.
Performed under controlled, factory- Performed in the actual operating
specific conditions, typically without the environment, where real-world conditions,
Testing
influence of external environmental or such as temperature, humidity, and system
Conditions:
operational factors. integration, may affect equipment
performance.
 Installation qualification (IQ)
IQ should be performed on equipment, facilities, utilities, or systems.
IQ should include, but is not limited to the following:
 Verification of the correct installation of components, instrumentation, equipment, pipe

work and services against the engineering drawings and specifications.
 Verification of the correct installation against pre-defined criteria.
 Collection and collation of supplier operating and working instructions and maintenance
requirements.
 Calibration of instrumentation.
 Verification of the materials of construction.
 Operational qualification (OQ)
OQ normally follows IQ but depending on the complexity of the equipment, it may be performed
as a combined Installation/Operation Qualification (IOQ).
OQ should include but is not limited to the following:

 Tests that have been developed from the knowledge of processes, systems and equipment
to ensure the system is operating as designed.
 Tests to confirm upper and lower operating limits, and /or “worst case” conditions.
The completion of a successful OQ should allow the finalization of standard operating and
cleaning procedures, operator training and preventative maintenance requirements.
 Performance qualification (PQ)
PQ should normally follow the successful completion of IQ and OQ. However, it may in some
cases be appropriate to perform it in conjunction with OQ or Process Validation.
PQ should include, but is not limited to the following:

 Tests, using production materials, qualified substitutes or simulated product proven to
have equivalent behaviour under normal operating conditions with worst case batch
sizes. The frequency of sampling used to confirm process control should be justified.
 Tests should cover the operating range of the intended process, unless documented
evidence from the development phases confirming the operational ranges is available.

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Qualification Stages for Equipment, Facilities, Utilities and Systems

 User Requirement Specification (URS)

 What is Design Qualification (DQ)?

 Design Qualification Process

The steps are as follows:

2. Supplier Evaluation and Selection:

3. Review of Equipment Design

5. Final Design Approval

 Factory Acceptance Testing (FAT)

 Verification of design specifications

 Installation qualification (IQ)

IQ should be performed on equipment, facilities, utilities, or systems.

IQ should include, but is not limited to the following:

 Verification of the correct installation of components, instrumentation, equipment, pipe

 Operational qualification (OQ)

OQ should include but is not limited to the following:

PQ should include, but is not limited to the following:

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