A company recently received this 483 observation:
…..Document control procedures have not been adequately established.
Several signed, original copies of procedures, including SOP ….., “Tank Installation and Performance Validation,” and SOP ….., “Lot Number System,” were observed with handwritten updates that were not processed through your document control system.
For more observations pertaining to medical device manufacturing controls see Issue 1024 available today. It also has observations pertaining to manufacturing controls, data integrity and sterile manufacturing controls.