Validation, Acceptance and Qualification

Everything is dependent on an ingenious design. The initial concern is the product’s targeted use. Even the smallest details matter here. The reliability and useability of the product is validated before, during, as well as after production.

Validation

Validation is used to demonstrate and document that a process and system perform in accordance with specifications. In accordance with GMP/GAMP practices the development of a system is split up into a number of phases on the basis of the V Model. Each phase concludes with a handover document that serves as the starting point for the next phase. The objective of the validation is to ensure that processes are reliable and consequently produce high-quality products. This is key given that everything in the pharmaceutical and food industries often revolves around human and animal health. Risks must consequently be reduced to an acceptable level. To be able to demonstrate this, it is important to create effective documentation. Validation is the means used to demonstrate and document that a process and the associated system perform exactly in accordance with the specifications.

 

This is why testing is a key activity throughout the entire validation process. For each specification or design phase on the left side of the V Model, there is a corresponding integration and test phase on the right side. For all test phases, a protocol is prepared in advance and the results are documented in a phase acceptance report. For example, the results of an FAT protocol are documented in an FAT report.


Acceptance: FAT & SAT

To meet GMP/GAMP requirements and pass government inspections, testing the systems is simply not sufficient. There must be demonstrable evidence that the systems perform precisely in accordance with their specifications. Failure of systems to perform well can result in dangerous situations, financial losses, damage and even loss of life. The objective of the Factory Acceptance Test (FAT) and the Site Acceptance Test (SAT) is to detect and remedy quality problems as early as possible in the process lifecycle. FAT and SAT are acceptance tests: a well-planned, documented and managed engineering approach for the start-up and handover of facilities, systems and equipment to the end user.

 

The supplier, as well as the user, has a major stake in the handover of new installations: the user wants an installation that is suitable for its targeted use and virtually problem-free during its operation, while the supplier aims to minimise aftercare costs. The new installations are therefore subjected to various tests in support of these common interests. First, the FAT is carried out at Veenbrink RVS’s location. A test setup is constructed for this purpose that largely incorporates the ultimate system and that is used to simulate various situations. This way any deviations are detected at an early stage where they still only have a limited impact and can quickly be remedied. This happens before the installation is transported to the customer’s location. After the FAT has been carried out and any defects have been remedied, the system is transferred to the customer location where it is integrated into other systems and networks. An SAT or integration test is conducted onsite. At this point the connection and interaction with adjoining installations can be tested. In addition, tests can be carried out to ensure that the system works with locally available facilities, such as electrics, water, steam, compressed air or CIP cleaning systems. In addition, end users can now be involved in conducting the tests.

Qualifications: DQ, IQ, OQ & PQ

While the FAT and SAT are classified as acceptance tests, the IQ, OQ and PQ concern qualification or user tests. FAT and SAT are sometimes also referred to as pre-qualifications and are used to effectively qualify the installation. Design Qualification (DQ) actually takes place before the process equipment is in fact produced. During Design Qualification the design is critically evaluated and approved at different stages, ranging from the conceptual design to a completely developed detailed design. During the Installation Qualification (IQ) the system is assessed in terms of the technical specifications. The installation is inspected to ensure it has been connected and installed correctly. During the Operational Qualification (OQ), the installation is tested to ensure that all aspects designed to ensure product quality actually function as intended. The Performance Qualification (PD) tests the system’s actual performance within the organisation. This test in particular assesses the quality of the delivered output. This is generally determined by completing a number of runs to produce the desired end product.

 

Some of the results from the FAT and SAT tests can be incorporated into the qualification tests. This can be very advantageous. It results in tremendous cost savings and potentially also reduces elapsed time. After all, why re-test everything when all of the test results are already available? However, sometimes the end user is forced to invest in the quality of the supplied documentation. Risks must be taken into consideration in this respect. Depending on the installation’s impact on the end product’s quality, a decision may be taken to conduct qualification tests in addition to the FAT/SAT acceptance tests or to forego these tests.


Contact us


Whether you are looking for high-quality process equipment, or have any questions about any of our products, do not hesitate to contact us! You can contact us using the adjacent contact form or by calling us at the telephone number shown below.

Veenbrink RVS

General

+31 (0) 348 47 50 41

privacy statement