This Cleaning Memo focuses on the signage (labels) that should be used during routine cleaning of equipment in pharmaceutical manufacturing facilities. It will cover possibilities for verbiage to be used in those temporary signs at various times during the cleaning process.
The purpose of such signage is to make sure the various steps in a cleaning process are done in the proper order and they are done in a way that doesn’t compromise manufactured product (which would include the product just made that will be cleaned as well as the next product made in the cleaned equipment). Here is a possible sequence of signs that could be considered for use.
It should be noted that some companies may want to include signs at even more intervals, whiles other may want to collapse the number of intervals. These will be determined by the benefits and risks of doing so. Such signage wording and usage should be captured in a SOP covering the entire facility (so that training and compliance are easier).
It should also be noted that the FDA has a “Q&A on CGMP – Production & Process Controls”) dealing with the issue of such signage. It basically states that such labels are “temporary” and need not be retained with the batch records. It further states that the signs do not have to be labels, but could be “dry erase” boards. Here is the text from the FDA website.
“The CGMP regulations for finished pharmaceuticals require the retention of cleaning and use logs for non-dedicated equipment, but no similar requirement exists for retaining what are intended to be quick reference or temporary status labels. Examples of these kinds of status labels include mixing lot ###; clean, ready for use as of d/m/y; and not clean. We see 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 nondedicated equipment.
Labels are merely one way to display temporary status information about a piece of equipment. It is considered acceptable practice to display temporary equipment status information on dry-erase boards or chalkboards. And it would be appropriate for an FDA investigator to verify that the information on a temporary status label is consistent with the log.”
Finally, this Cleaning Memo does not deal with additional signage that may be used during cleaning validation protocol execution to make sure that specified validation protocol parameters (such as making sure that the dirty hold time is at the maximum and making sure that validation sampling is done) are achieved.
I can’t emphasize enough that correct and useful signage (as well as training on its use) is important to assist in making sure the cleaning process is done correctly and efficiently. Such signage may also be helpful during a regulatory inspection, so that a visual inspection of equipment by auditors appropriately considers whether there is an expectation that the equipment be visually clean.