5 Commonly Overlooked Laboratory Checks for your FDA cGMP Audits

April 1, 2015 | Posted by Team in Lab Admin Tools |

This blog post is a guest post from Edword Simpson, technical engineer at Science Exchange lab, RS Calibration.

labcheck

Ensuring that everything in your laboratory is ready for any upcoming audit is a nail-biting task. The annual FDA audit for compliance with regulatory guidelines, like the current goods manufacturing process (cGMP) is especially tedious. Manufacturing processes and equipment for pharmaceuticals are regulated very carefully by the FDA and require strict adherence to industry standards.

 

Here are five things that aren’t always given the attention they require and could easily result in regulatory action for failing to comply with cGMP: Read the rest of this entry »

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