FALLS CHURCH, Va., Jan. 24, 2013 /PRNewswire-iReach/ -- Good Distribution Practices Summit
**Presented by FDAnews**
March 18-20, 2013 – Bethesda, MD
FDA-Regulated Manufacturers — If one syringe goes missing in your distribution chain, you could be facing a total recall. Or, if your product exceeds its maximum allowed temperature by a fraction of one degree, the whole lot might have to be destroyed.
Welcome to the emerging — and risk filled — world of good distribution practice (GDP) compliance.
For example, a product may be manufactured at a foreign facility, shipped by air or ship to the US, transferred through an airport or port, loaded onto a truck, moved between 2-3 distributors all before reaching the pharmacy or patient. At any of those points, if you can't convince regulators you have maintained security and stability controls, you could be looking at a Form 483 or other warning.
Inspectors are requiring manufacturers to prove they have adequate risk management controls in place AND provide detailed records and test results that assure temperature stability of past shipments.
The truth is, you're in for more headaches and complications. But there's help close at hand. FDAnews welcomes you to Washington, D.C., to learn and share with your colleagues best practices to maintain GDP compliance.
Come to Washington Monday-Wednesday, March 18-20, 2013, for the Biopharmaceutical Good Distribution Practices Summit.
It's three days and two nights of face-to-face interchange with regulators, GDP pioneers, po
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