The initial achieved qualification status has to be maintained durably. For this purpose, relevant influencing factors on General Manufacturing Process (GMP) have to be checked periodically. The regulatory requirement of requalification is mandatory worldwide. Prominent superordinate regulations are the GMP guidelines of the US and the EU as well as the guidelines of PIC/S.
According to these guidelines, requalifications have to be performed periodically. This requirement concerns facilities as well as plants and equipment and includes the execution of important quality controls like particle counting, microbial counting and temperature distribution measurements.
Further, there is a wide range of further applications which require requalifications, e.g. change on equipment or environment, use of replacement devices, replacement of components in production plants or whole transfer of a production site. In addition to these risk-based assessments, negative trends or findings from root analysis often lead to requalification requirements. The requalification is thus part of the basic GMP demand, which is transferred to the pharmaceutical industry.
As part of Bosch Packaging Technology, Valicare GmbH has its main business in pharma industry, biotechnology, ATMPs and medicine products. Since 2002, we support our customers from the global market during the whole pharmaceutical implementation process, starting with preparation of User Requirement Specifications (URS) and finishing with the last qualification phase, as well as executing requalification projects.
Use the time you gain for routine daily tasks or urgent projects, while we qualify your plants in accordance with GMP and the actual technical standards. Valicare GmbH offers GMP-compliant support for each qualification phase. We would be pleased to advise you by phone.
Dr. E. Sons-Brinkmann
Phone: +49 69 7909 350