Should Equipment Status Identification Labels be retained with the Batch Record?
Keeping equipment status identification labels with the batch record provides additional confirmation during the review process. But is it required?
Keeping equipment status identification labels with the batch record or other files is often done to provide additional confirmation during review of the record. It supports verification that certain equipment was cleaned before usage for manufacturing. But is it required?
The U.S. Food and Drug Administration FDA has answered this question in an Q&A Document. Assuming each major piece of equipment has a unique “Cleaning and Use Log” that is adequately retained, these “quick reference” equipment labels can be discarded according the agency. FDA sees “no value in the retention of such labels in addition to the required equipment log or batch record documentation. The labels serve a valuable, temporary purpose of positively identifying the current status of equipment and the material under process. Any status label should be correct, legible, readily visible, and associated with the correct piece of equipment. The information on the temporary status label should correspond with the information recorded in the equipment cleaning and use log, or the previous batch record for non-dedicated equipment.”
However, as said before, it might be useful keeping these labels in a batch record. Many companies are doing so; not because it is a requirement but it is a helpful and reliable practice.
/////////
Filed under: Regulatory Tagged: batch record, equipment status identification labels
