FAT, SAT, IQ & OQ · Equipment testing and qualification for GMP manufacturing environments

Validation is a fundamental requirement in GMP manufacturing environments, where equipment must be controlled, documented, and verified throughout its lifecycle. Comecer provides a structured validation approach covering Factory Acceptance Test (FAT), Site Acceptance Test (SAT), and optional Installation Qualification (IQ) and Operational Qualification (OQ) activities for pharmaceutical and radiopharmaceutical systems.

This validation process supports traceability from factory testing through on-site qualification, helping manufacturers reduce commissioning risk, document critical verifications, and prepare systems for operation in regulated production environments.

Structured validation from factory testing to on-site qualification

Comecer applies a validation workflow that begins at its manufacturing facility and continues at the customer’s site. The validation process includes factory testing under controlled conditions, verification after installation, and optional qualification activities performed in the real operating environment.

• Factory Acceptance Test (FAT) before shipment
• Site Acceptance Test (SAT) after installation
• Optional IQ and OQ protocols performed on-site

Each phase is designed to verify system conformity with approved specifications, operating conditions, and applicable GMP expectations.

Factory Acceptance Test (FAT)

The Factory Acceptance Test is performed at Comecer’s facility before shipment to verify that the equipment is assembled correctly, functions as intended, and corresponds to approved project specifications. FAT allows technical and documentary checks to be completed under controlled conditions before the system is installed at the customer’s site.

The FAT process typically includes:

• Verification of instrumentation, calibration certificates, and qualification documentation
• Design and construction checks against approved drawings, schemes, and specifications
• Functional testing of mechanical operations, alarms, and software interlocks

Depending on the system configuration, FAT may also include safety and performance tests such as glove breach testing, leak tightness verification, and filter integrity testing.

For systems operating in controlled environments, FAT can also include tests related to cleanroom and airflow performance, such as smoke pattern analysis, air velocity and air change rate measurements, and non-viable particle counting. For reference, cleanroom airborne particle cleanliness classification is addressed in ISO 14644-1. Completing these activities at the factory stage helps identify issues early and reduces risk during commissioning.

Site Acceptance Test (SAT)

The Site Acceptance Test is performed after installation to verify that the system operates correctly in the customer’s real production environment. SAT confirms that transport, installation, utilities, and site conditions have not affected system performance and that the equipment remains aligned with FAT results.

SAT activities generally include:

• Installation and configuration checks
• Verification of main components, finishing quality, and utility settings
• Repetition of critical functional and interlock tests performed during FAT
• Process-specific operational checks, depending on the equipment type

Safety validation and operational readiness are also part of SAT. These activities may include verification of safety devices and interlocks under real conditions, together with operator training for correct use and maintenance.

A key output of the SAT phase is the delivery or completion of the documentation package required for traceability and project handover. This may include FAT records, user and maintenance manuals, spare parts documentation, as-built drawings, material certificates, calibration certificates, and welding qualifications.

Installation Qualification (IQ) and Operational Qualification (OQ)

As an optional service, Comecer performs IQ and OQ activities on-site through its validation team. Installation Qualification verifies that the system has been installed in accordance with design requirements, approved documentation, and applicable regulatory expectations. Operational Qualification verifies that the equipment performs reliably within predefined operating parameters.

A key aspect of this phase is continuity with FAT. The IQ/OQ protocols follow the same validation logic already applied during factory testing, so that checks are repeated in the actual production environment using calibrated instruments and standardized qualification documentation.

• Replication of relevant FAT checks on-site
• Execution of tests with calibrated instruments
• Documentation of results through formal qualification protocols

This approach helps confirm that the system is not only technically functional, but also suitable for operation under real installation and process conditions.

Validation activities aligned with GMP expectations

Through FAT, SAT, and optional IQ/OQ activities, Comecer supports manufacturers in implementing a documented qualification path aligned with GMP manufacturing requirements. In Europe, sterile manufacturing expectations are defined in EU GMP Annex 1. Where electronic records and signatures are part of the control system environment, additional requirements may also be relevant under 21 CFR Part 11.

By combining factory testing, site verification, and optional qualification services, Comecer provides a validation framework that supports documentation completeness, operational readiness, and more controlled system start-up in pharmaceutical and radiopharmaceutical environments.

Discuss your validation scope with Comecer

If you are preparing a new installation, reviewing project qualification requirements, or defining the documentation needed for commissioning and validation, contact Comecer to discuss the FAT, SAT, and IQ/OQ scope best suited to your system and production environment.