According to the Code of Federal Regulations (21 CFR 211.22(a) Responsibilities of quality control unit), […]
An important way to avoid receiving an FDA 483 after an inspection is to be prepared for your audit.
Being prepared means you are up to date on the latest regulations and FDA inspector’s interpretation of them.
You can request FDA 483s through the Freedom of Information Act, you can read all the reports, you can compile the observations and determine which ones are happening most frequently or you can subscribe to the GMP Trends publications where we do the work for you.
GMP Trends has multiple reports to help keep you in compliance.
The GMP Trends bi-monthly report is a compilation of relevant 483 observations edited for significance. The 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.
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. The report includes, Review of FDA Inspections each Fiscal Year, Examples of cited observations from actual Form 483s, Trend of top cited observations for Drug and Device Facilities. The report is published in the first quarter of the year.
A summary of drug and device facilities that were inspected by the US FDA during a certain quarter. The report includes domestic and forgein inspections. Report is in excel format and allows you to sort as you need. It includes whether or not facility received a 483, the length of the inspection and CFR citations where available.
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A subscription to GMP Trends means you stay up to date on the latest information and ensures you do not miss anything. We have multiple subscription packages to help you stay complaint. Refer to the pricing page for details of each package.
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Bi-monthly reports will be posted to the website on the 1st and 15th of each month. You will receive a courtesy email on the 1st and 15th letting you know the report is available to view.
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The Bi-Monthly Trends Report
Our Bi-monthly GMP Trends Report gives our readers the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format.
A company recently received the following observation: …..Written procedures are not established for the cleaning […]