According to the Code of Federal Regulations (21 CFR 211.22(a) Responsibilities of quality control unit), […]
Why GMP Trends®?
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.
What is the GMP Trends bi-monthly report?
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.
What is the GMP Trends Special Topics quarterly 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.
What is the GMP Trends Annual Report?
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.
What is the GMP Trends 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 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.
Can I forward or copy the reports to other colleagues after I purchase them?
No, contents of GMP Trends® are protected by U.S. Copyright Law. Reproduction of any type is strictly prohibited by law. Authorization to photocopy for internal or personal use can be granted by contacting Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400 or (855) 239-3415. E-mail: info@copyright.com, www. copyright.com
Why should I subscribe to GMP Trends?
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.
How do I subscribe to a package?
To subscribe to a package, select Pricing from the top menu. Then select the package that you are interested in. Follow the prompts to complete your order.
How can I renew my subscription?
Your subscription will automatically renew either monthly or annually, depending on what you chose upon checkout. If you’d like to cancel, visit the Subscription section under Manage My Account.
What is the difference between the Store and a subscription package?
Customers that subscribe to a lower package can buy additional reports offered to higher packages.
Those not interested in a subscription can also purchase any report offered in the packages. All reports are cheaper if purchased as part of a package.
Can I pay by check or invoice or must I use a credit card?
GMP Trends would prefer you use a credit card to complete all orders. If this is not possible, please contact us at gmp@gmptrends.com.
How do I receive my information?
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.
How can I renew my subscription?
Your subscription will automatically renew either monthly or annually, depending on what you chose upon checkout. If you’d like to cancel, visit the Subscription section under Manage My Account.
How do I change my account information?
You can change all of your account details, and change your password by visiting the Manage My Account page from your account dashboard.
How do I add additional colleagues to my account?
Log into your account. Click on Manage My Account and select Teams from the menu on the left.
If you are the account manager, you will be able to add additional colleagues here. The Plus Package has 3 users and the Professional Package has 5 users.
This feature is not available for the Basic Package.
I forgot my username and/or password, now what?
If you forget your username or password, click here to reset it. You can also use your email address to login
Join the thousands of professionals who rely on GMP Trends® to keep them informed of the latest FDA Enforcement Trends!
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: …. Procedures to ensure that all purchased or […]
A company recently received the following observation: …..Written procedures are not established for the cleaning […]