Validation

Regular validation and calibration of pharmaceutical testing instruments is mandatory. The instruments can only be used after having been validated and they must be marked accordingly.

ProSense offers a validation and calibration service in accordance with the USP-, FIP- and GMP guidelines. This service is not only available for all ProSense products but also for others. This includes Installation Qualification (IQ), Operational Qualification (OQ), each with the corresponding validation documents. In addition the required system suitability test or performance qualification (PQ) using USP calibration tablets can be performed by our specialists. ProSense actively participates in the USP multi-centre studies to determine the limits for these single lots. ProSense validation specialists frequently perform these PQ-tests and so are experienced in their execution.

These services are utilised by a wide variety of companies: small companies not having the technical know how but also multinational companies. The corresponding standard operation procedures (SOP's) and control protocols have been developed over many years in conjunction with the pharmaceutical industry. They are constantly reviewed and extended to ensure that compliance with latest regulatory authority requirements (FDA, MCA) is guaranteed. The validation documents are signed by the ProSense validation specialist and the company's internal responsible person.

Validation can be ordered as required or alternatively validation contracts on an annual basis are available, enabling ProSense to manage your instrument validation requirements on your behalf.