DECONTAMINATION AND DEPYROGENATION IN ASEPTIC FILLING OPERATIONS

摘要

No one ever got fired for buying IBM; this 1970s adage succinctly captures the conservatism of the biopharmaceutical industry. That is not to say that conservatism and caution are not required when patient safety is at risk - but how much of this is driven by the fear, uncertainty and doubt of incumbent suppliers defending existing technology? The 'c' in cGMP is for 'current' and indicates that the GMPs are not static and should move with the times. To quote the FDA: 'The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement', and 'systems and equipment that may have been 'top-of-the-line' to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's standards'.