ARTICLES BY JERRY CHAPMAN
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![Top5]( "FDA's Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis")
FDA's Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis9/16/2019This is the second part of a two-part article counting down the FDA’s top 10 most-common drug GMP inspection citations for the agency’s 2018 fiscal year (FY2018).
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![Top 10]( "FDA Analysis Of The Top Drug GMP Inspection Citations In FY2018")
FDA Analysis Of The Top Drug GMP Inspection Citations In FY20189/4/2019In this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann present the agency’s top 10 drug GMP inspection citations for FY2018 and provide insight into the observations. This part unveils citations #10 through #6, and Part 2 will cover citations #5 through #1.
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![us-eu-flags]( "How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often")
How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often7/13/2018The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency.
Jerry Chapman
Jerry is Govzilla’s senior GMP quality expert. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly, where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality roles. In corporate quality, he designed and implemented a comprehensive GMP Intelligence process to identify, analyze, and archive pertinent drug GMP regulations, inspection findings, trends, and best practices in the U.S. and internationally. Chapman was founder and chairman of the GMP Intelligence subgroup of the Midwest Discussion Group from 2005 to 2010. He also served as senior editor at International Pharmaceutical Quality for six years; has been an invited speaker at PDA, AAPS, ISPE, and RAPS events; and was a consultant for the animal health and compounding pharmacy industries.