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For Your Best Storage Process
For Your Best Storage Process
Develop the best process for stability storage in the pharmaceutical industry and make it available worldwide
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Posts Tagged with Inventory

FDA 483 Tips #5

FDA 483 Tips #5

May 29, 2016

Related FDA483/Warning Letter The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically: Sub section (b)There is no written standard operating procedure in place to (A) control, secure, and allow authorized personnel to access the stability chambers. It appears that...

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Chain of Custody / 483

Chain of Custody / 483

April 12, 2016

Chain of Custody is the documentation of your samples lifecycle history. Most people don’t realize that Chain of Custody starts very early in the manufacturing process and continue through the testing phase. All stages of a sample’s life cycle have some sort of chain of custody or an inventory...

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