Privatsphäre-Einstellungen

Today there is the duty to perform a trending of all data evaluated in production areas. This is especially relevant to the microbiologists in the quality control (QC) and/or quality assurance (QA) departments. This trending does not only include analytical product data - which represent the basis for the product release decision - but also covers data that have been evaluated „process-relatedly“. Because only if a demonstrable proper product environment is guaranteed, it is ensured that also the final product will comply with the respective requirements - besides the product-relevant quality of drug substance and excipients.
This is also reflected in the authorities’ requirements and in the inspection practices which focus on the very strict supervision of the manufacturing process of the product; in this context even parametric release (release without the sterility testing of terminally sterilized products) is under discussion.
But before taking this into account, all requirements which are directly related to a release decision have to be defined according to corresponding requirements; action and warning limits are fixed to be able to assess the produced batches. Nevertheless, today’s practice even requires more than limits and their observance to supply evidence that all production areas are under control from an up-to-date point of view. Evaluation, analysis and taking consequences of trending results are expected to be implemented into the daily duties of QA/QC departments by the authorities. Furthermore, alert and action levels have to be defined specifically to each individual filling line or implementation of target values lying beyond these levels are proposed. They should reflect the current hygiene status of a specific production area and shall be used to take preventive action before exceeding limits.
A trending model covering the expectations mentioned above is presented in the following paper. The model was evaluated by Novartis Pharma AG (at site Stein in Switzerland) and has been applied at the quality management of sterile production for many years.