A company recently received this 483 observation:

…. 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.

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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