The qualification of machines and systems is essential in the regulated environment of the pharmaceutical industry in order to ensure product quality, patient safety and regulatory compliance. This scientific approach ensures that equipment is installed according to the manufacturer’s specifications, functions correctly and delivers the expected results.
User Requirement Specification (URS)
The User Requirement Specification (URS) marks the start of the qualification process. It defines in detail the performance, functional and compliance requirements for the equipment and is decisive for the selection of suitable machines and systems.
The risk-based approach
A risk-based approach to qualification makes it possible to prioritize activities according to the potential risk to product quality and patient safety. This approach supports the efficient use of resources and guarantees the targeted implementation of training.
Steps in device and system qualification
System requirements and restrictions
What should the system achieve, what should the system include?
The URS is the basis for qualification.
Do the characteristics of the planned equipment meet all predefined requirements?
Documented proof that the equipment is designed as ordered.
Has the equipment been set up and installed professionally?
Are all technical specifications met?
Documented proof that the equipment has been installed as specified.
Does the equipment function according to the previously defined specifications?
Documented proof that the equipment functions as specified by the manufacturer.
Are the performance requirements met with the product installed?
Documented proof that the equipment provides the previously defined performance.
Commissioning after successful qualification.
Process and cleaning validation
Process validation confirms that the production process consistently produces high-quality products. The cleaning validation ensures that no impurities impair the product quality. Both are an integral part of quality assurance.
Timetable and implementation
A structured qualification schedule begins with the URS and continues with the DQ, IQ, OQ and PQ. Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) must be carried out before final commissioning to confirm compliance with the requirements.
The role of HET Filter
At the end of this extensive and scientific process is the need to rely on proven and innovative solutions to meet the high demands of the pharmaceutical industry. This is where HET Filter offers a valuable resource with its specialized expertise in filtration technology. With customized solutions that are specifically tailored to the needs of pharmaceutical production, HET Filter ensures that the qualification of machines and systems not only meets regulatory requirements, but also increases the efficiency and quality of production processes.
If you want to ensure that your production processes meet the highest standards, we invite you to get in touch with HET Filter. Our expertise in filtration technology can optimize your qualification processes and lead to excellent results.
Conclusion: The central importance of qualification in the pharmaceutical industry
The qualification of machines and systems is a decisive step in ensuring product quality and safety in the pharmaceutical industry. Through a methodical and scientific approach, this process not only enables compliance with regulatory requirements, but also the optimization of production processes. The application of a risk-based approach and the thorough planning and execution of the qualification steps from DQ to PQ are essential to ensure the integrity and efficiency of pharmaceutical manufacturing.
HET Filter’s expertise, especially in filtration technology, contributes significantly to the realization of these quality and safety goals. With tailor-made solutions and specialized know-how, HET Filter supports the pharmaceutical industry in meeting not only current but also future requirements. Working with an experienced partner like HET Filter therefore offers clear added value and helps companies to continuously improve their processes and make a contribution to global healthcare.
