AMU - Comment

Document ID: FDA-2010-N-0548-0003
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: December 23 2010, at 12:00 AM Eastern Standard Time
Date Posted: December 28 2010, at 12:00 AM Eastern Standard Time
Comment Start Date: December 21 2010, at 12:00 AM Eastern Standard Time
Comment Due Date: February 22 2011, at 11:59 PM Eastern Standard Time
Tracking Number: 80bbef1e
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I agree with this proposal to update the regulation to ensure that good laboratory practices are being performed at all times. Considering a lot has changed since 1978, updating this regulation would ensure and inform personnel of the importance of nonclinical laboratory operations. This update will ensure that the laboratories have computer based technology that would improve the accommodations and accurately of their studies. This advance in technology would ensure that the laboratories are compatible and up to date with today’s technology. These modifications would enable the laboratories to improve in the advancement of their studies. I agree with having an individual that would be responsible for each study, this would ensure that all activities at the facility are conducted and are being overseen by a specific individual. The changes that the FDA is considering will be a great benefit to laboratory studies and will improve the quality of test studies all around.

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