Where the results of a process cannot be fully verified by subsequent inspection, test or other form of quality monitoring in a sufficient or cost efficient way, SP Medical will perform validation according to established procedures and predefined requirements. The validation degree is based on complexity and knowledge of the product and process.
The main purpose of the validation is to establish the objective evidence for the installation, process control limits and repeatability and reproducibility of the product to fulfil all predetermined requirements and by that ensure the continuous product quality and process stability.
Additionally the validation is performed to ensure stability of the process by elimination of the observed variations and ensuring continuous achievement of the desired product quality.
SP Medical performs validation of manufacturing equipment according to GHTF guidelines as well as other guidelines as GAMP, FDA's 21 CFR 11 and other standards.
Periodically and according to knowledge and risk associated with the process, a re-validation is carried out, which takes into account evaluation of at least 16 factors such as impact of Change Request (CR) implemented in the process, CAPA (Non Conformity Reports), Audits, NC or observations, calibration, maintenance, review of logbooks, error rate, suppliers agreements etc.