Qualification of pure areas

Produce after GMP demand the examination and validating of all plants, systems and processes, which have influence on the product. The production environment, thus under others air and/or the premises has a large influence on the quality of the production. The EEC GMP guideline demands the qualification of the quality influencing plants, to which the supplying ventilation systems and also the pure area belongs. The Valdierung contains the calibration, qualification and validating strictly speaking. The calibration of the plants or measuring sensors means a comparison with reference equipment, thus equipment with higher accuracy. Here must be worked with high quality, an experience of many years can from large use be. Validating contains the proof that procedures actually lead expecting results to. Detailierte information in the attached pdf document