A software designed to judge deviations from acceptable temperature ranges throughout the storage and transport of pharmaceutical merchandise manufactured by Sanofi. It assists in figuring out the potential impression of those deviations on product high quality and efficacy. This analytical instrument permits professionals to enter particular parameters, corresponding to temperature readings exterior the desired limits, period of the tour, and related product data. The system then assesses the chance related to the temperature variation, offering a scientific foundation for decision-making relating to the continued usability of the affected product batch.
Sustaining pharmaceutical product integrity is essential for affected person security and therapeutic effectiveness. Unplanned temperature variations can compromise a drug’s chemical stability, resulting in decreased efficiency or the formation of dangerous degradation merchandise. The calculator offers a standardized and constant technique for evaluating such occasions, minimizing subjective interpretations and selling data-driven decision-making. Traditionally, assessing these conditions relied closely on knowledgeable opinion and restricted information. This calculator facilitates a extra rigorous and clear course of, enhancing provide chain administration and lowering potential product waste.
