GMP Trends Newsletter
Join our mailing list for free news and highlights from recent FDA Inspections Reports and enforcement actions along with compliance tips from our expert editors. The topics include manufacturing controls, laboratory controls, and medical device controls.
Bi-Monthly Trends Report
A compilation of relevant 483 observations edited for significance. The report covers observations for manufacturing controls, laboratory controls, and medical device controls. Each issue also features a rotating category. These rotating categories include Sterile manufacturing controls, active pharmaceutical ingredient manufacturing controls, packaging and label controls and data integrity.
Inspected Facility List
A summary of drug and device facilities that were inspected by the US FDA during a certain quarter. The report includes domestic and foreign inspections. The report is in excel format and allows for sorting based on selected criteria. It includes whether or not a facility received a 483, the time duration of the inspection and CFR citations where available.
Special Topics Report
The GMP Trends Special Topics quarterly report expands on the bi-monthly report by focusing on just one specific topic regardless of industry. Special Topic reports contain observations about change control, validation, stability, etc.
The GMP Trends® Annual Report is a review of FDA Inspection Observations for the previous Fiscal Year. The report includes examples of cited observations from actual Form 483s, trends of top-cited observations for Drug and Device Facilities. The report is published in the first quarter of the year.