Validation ensures and documents the most important properties of processes: Reproducibility and robustness. And thus guarantees your GxP standards in sectors such as the pharmaceutical industry and medical engineering in addition to risk-based qualification.
Testo Industrial Services supports you in individual validation projects or takes over the complete handling. The area of validation includes cleaning validation, transport validation, process validation or computer and software validation. For all validations a risk-based approach is the basis of our tailor-made services for you.
The term "validation" is to be understood as an umbrella term and includes, for example, process validation, cleaning validation, method validation and the qualification of technical systems. In a GMP-compliant validation, manufacturing processes, medical devices or machines and systems are checked to see whether they meet defined usage objectives. The FDA defines validation as "a process by which, using specific laboratory testing methods, it is demonstrated that the performance of an analytical method is appropriate for its intended use".
In pharmaceutical manufacturing, for example, process validation is an important quality assurance tool. The GxP guidelines require the validation of processes that have an influence on product quality, unless 100% control is implemented in the process itself. In process validation, the real end product is used to test whether a process that always runs under the same conditions (e.g. pressure, temperature or humidity) always delivers the desired result. Thus, documented, reproducible conditions guarantee the quality of the end product.
Computer/software validation (CSV) is carried out in the pharmaceutical sector in accordance with the GAMP 5 guideline (Good Automated Manufacturing Practices). There the V-model is specified as the most common model for the validation of computer-aided systems.
"The employees of Testo Industrial Services have integrated themselves excellently into the existing team. The professional training was very good, which was reflected in the implementation and structuring. Also the broad application knowledge, from pure process knowledge to optimization strategies for cleaning processes to regulatory knowledge in the field of cleaning validation".
Dr. Michael Pfeil, Manager at Merz Group Services GmbH
