Just as we’ve seen in many FDA 483 observations, there must be written procedures for rejected inventory. Your rejected inventory must be tracked properly to ensure that it does not find its way back into production or distribution after a rejection.
Regardless of the reason for rejection, a Standard Operating Procedure must be in place for the handling, storage, and disposal of these materials. This process must be tracked from beginning to end and all inventory must be accounted for in writing. The FDA’s Material Systems Basic cGMP Requirements outlines the details around these provisions.
A company recently received this 483 observation:
ā¦.. Written procedures are not established and/or followed.
Specifically, there is no established written procedure for the transport, handling, storage, and destruction/disposal of rejected material, at the firm or disposal inventory record to track and account for the amount of rejected material destroyed by the firm. Since there is no system for tracking, identification and disposal record for rejects, there is no way to effectively ensure that rejected material is actually destroyed and not returned into the inventory for reprocessing.
For more observations pertaining to inventory control, seeĀ Issue 1043. Ā For more observations pertaining to rejected material see Issues 1077, 1069, 1066, 1065.
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