Other CMC/GMP Developments Reported by IPQ

Global News Updates in Brief

IPQ lists CMC/GMP developments in the global arena, with links to the referenced documents and to our related in-depth analysis.

FDA Warning Letters

Drug GMP warning letters posted by FDA are ordered chronologically by letter date. The main areas of concern are listed along with links to the warning letters themselves. Included is a summary of the letter’s most noteworthy features.

EMA Non-Compliance Reports

Drug GMP non-compliance reports posted by EMA are orderd chronologically by report date. The main areas of concern are noted, and links provided to the compliance reports themselves. Included is a summary of the report’s salient features.

FDA Drug Recalls

IPQ provides a list of the drug product recalls included in FDA’s weekly Enforcement Reports. Included are the generic names of the products, the dosage form, the manufacturer, the number of lots involved, FDA’s classification, and the specific reason provided by FDA. The recalls are grouped by the general category of problem that caused them. The categories, not all of which are represented in any given month, are: ● contamination/lack of sterility assurance ● GMP/GDP ● impurity/foreign substance ● labeling/packaging ● NDA/monograph compliance ● particulate ● potency/content uniformity ● dissolution/stability, and ● other spec nonconformance. Within the categories, the recalls are organized by class, with the most serious recalls (Class I) listed at the top.