Are you testing your water system regularly?

A company recently received this 483 observation: 

…..There was a failure to handle and store components at all times in a manner to prevent contamination.

Specifically, ….a review of the water sampling log over the last 18 months revealed intermittent water testing performed.  During that time, a water sample was taken from a point of use port that had an aerobic plate count of …..  This failure was captured in an OOS Investigation; however, no risk assessment was performed, and the system was not subsequently sanitized.  Your firm re-sampled the water and reported the new results.  This potentially affects at least ….. drug product lots manufactured by your firm since that time.

For more details on this observation as well as other observations pertaining to Manufacturing Controls see Issue 1018 available today.  It features observations pertaining to Sterile Manufacturing on our rotating page 3 topic as well as Laboratory Controls and Manufacturing Controls.

Stay in Compliance! Subscribe today!

Become A Subscriber And Stay Ahead of the FDA

To get the most out of GMP Trends®, sign up to one of our subscription packages for valuable, up-to-date information you won't find anywhere else! Every subscription provides 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. Join the thousands of professionals who rely on GMP Trends® to keep them informed of the latest FDA Enforcement Trends!

SUBSCRIBE NOW