Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 43

Returning to Plate 1 we see the reference to current Good Manufacturing Practice (cGMP) regulations as it applies to the investigational drug product. The manufacturing of the investigational drug product must meet the cGMP regulations but on a graduating scale. FDA in 2008 published a guidance document describing its policy regarding the application of the cGMP requirements for Phase I investigational drugs. In summary, FDA provides some leeway for a manufacturer’s compliance with the full range of 21 CFR 211 requirements in the earliest stages of clinical testing but that leeway starts to evaporate once Phase II begins and by Phase III of clinical testing of a new drug the manufacture of the investigational drug product is expected to be in full compliance with 21 CFR 211. Whether that is always the case may be up for debate since the FDA from a programmatic standpoint does not routinely or programmatically inspect the manufacture of new drugs being used in clinical trials. That said if the FDA were to find that an investigational drug product was not being manufactured in conformance with applicable cGMP or was adulterated or misbranded they can and will act to contain its use if the responsible firm does not do so.