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6 BioPharm International eBook December 2019 Lessons from FDA 483s and cGMP Inspection Data Production and process controls, organization and personnel were the top problems found, while packaging and labeling citations increased in 2017 and 2018. T o prov ide insight into reg ulator y t rends and factors contributing to noncompliance, the authors analyzed data from Form 483 observations issued by FDA during routine i nvest igat ions of f i n ished d r ug a nd A PI manufacturing sites between 2014 and 2018. The goal was to provide pharmaceutical quality compli- ance professionals, managers, and operators with insights into how they can best strengthen compli- ance and develop appropriate solutions for key reg- ulatory compliance issues. This article summarizes results of the study. To rev iew the basics, for m 483s are issued by FDA's Office of Regulatory Affairs (ORA), which is responsible for field activities such as site inspec- tions and enforcement (1). OR A inspectors issue For m 483 obser vat ions when t hey f i nd c u r rent good ma nufac t ur ing prac t ice (cGM P) v iolat ions during a facility inspection. These observations are then presented to the company's senior managers to IVAN TRAIMAK - STOCK.ADOBE.COM AJAY PAZHAYATTIL is a management consultant ( MARZENA INGRAM is senior manager, quality and compliance at Eurofins CDMO. NAHEED SAYEED is deputy director, validation services at Sanofi. AJAY BABU PAZHAYATTIL, MARZENA INGRAM, AND NAHEED SAYEED Regulatory Sourcebook FDA Inspections

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