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.