Twice-Monthly Trends Report
The Twice-Monthly Trends Report is our flagship product. Published every two weeks, it complies relevant 483 observations, edited for significance: to you save time and to support your systems’ compliance. Observations covered include manufacturing controls, laboratory controls, and medical device controls, along with a rotating category such as Sterile manufacturing controls, active pharmaceutical ingredient manufacturing controls, packaging & label controls, and data integrity.
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GMP Trends Newsletter
Join our free mailing list for an elaboration on one topic from our most recent Twice-Monthly Report. Focused on manufacturing controls, laboratory controls, or medical device controls, our Newsletter details recent FDA Inspection enforcement actions and provides compliance tips from our expert editors.
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Inspected Facility List
The Inspected Facility List is a summary of domestic and foreign drug and device facilities that were inspected by FDA during a certain quarter. It specifies if an inspected facility received a 483, the time duration of the facility’s inspection, and its CFR citations, when available.
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Special Topics Quarterly Report
The GMP Trends Special Topics Quarterly Report expands on the Twice-Monthly report by focusing on one specific topic regardless of industry. Special Topic Quarterly Reports contain observations about topics including but not limited to change control, validation, and stability.
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Annual Report
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 Annual Report is published in the first quarter of the year.
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