The following 483 describes an organization denying FDA Investigators entry into a warehouse storing APIs, […]
GMP Trends has served Quality, Regulatory, and Manufacturing Professionals in pharmaceuticals and medical device production by trending 483’s and compliance data since 1979.
GMP Newsletter
Sent out twice a month, our Newsletter is an expansion of one facet of our most recent Twice Monthly Report. A single 483 is highlighted so that Quality, Regulatory, and Manufacturing Professionals can learn how to improve their own systems by learning from the mistakes of others. The Newsletter includes links to more information about each edition's topic. Our Newsletter is a free resource we are proud to provide to the Quality, Regulatory, and Manufacturing community as an effort toward our goal of equipping the community with Compliance Confidence. Sign up today to get our Newsletter in your inbox twice a month to support the improvement of your systems.
Twice-Monthly Trends Report, Annual Report, Quarterly Special Topics Report
Each of our reports is created with the same goal in mind: to equip your team with the information necessary to stay in compliance. Our reports increase the productivity of your team by keeping all involved informed on what other firms are messing up, so that your team can get it right the first time. GMP Trends Reports are an essential tool that can deliver value to every department pharmaceutical and medical device companies by supporting compliance and regulatory intelligence. Our clients have used our reports across their entire companies, using it on teams including QA, regulatory, chemist, operations, and manufacturing.Twice Monthly Trends Report
Our scientists use real, relevant, and recent 483's to write the GMP Trends® Twice Monthly Report every two weeks. This report covers observations for manufacturing controls, laboratory controls, and medical device controls. Each issue features a rotating category. These rotating categories include: Sterile manufacturing controls, active pharmaceutical ingredient manufacturing controls, packaging and label controls and data integrity.
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.
Quarterly Special Topics 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.
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.
GMP Newsletter
The following 483 describes an organization denying FDA Investigators entry into a warehouse storing APIs, […]
FDA cited a facility for failing to adequately test in-process materials for quality after extended […]
FDA recently cited an organization for egregious data integrity mistakes. Throughout time, staff developed workarounds […]