Rejected products and their associated procedures are a significant focal point throughout the FDA’s CFR 211. Specifically the handling, labelling, and disposing of rejected products is a recurring topic in 483 warning letters.
CFR 211.82 states “Each container or grouping of containers for components or drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected).“
A company recently received this 483 observation:
ā¦. Written production and process controls procedures are not followed in the execution of production and process control functions.
Specifically, SOP …, “Handling of Rejects in Packing”, states that all rejected material must be collected and stored in a properly labelled red crate. However, during inspection of your packaging operation … Capsules batch … the inline rejected material was noted as being collected in blue crates without proper identification of the material status.
Does your SOP include a procedure for handling, labelling and storing rejected products? The GMP Trends SOP Template is a free download and can provide some guidance with your operating procedures.
For more observations pertaining to manufacturing controls, see Issue 1048 available today. It also has observations pertaining to lab controls, sterile manufacturing controls and medical device manufacturers.
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