Just a little off the sides, please
"But after the set-up mechanic left, the machine alignment drifted slightly, and the first digit of the dosage strength was cut off of a bunch of labels, so it looked like a 50-mg product instead of a 150-mg product. Because we also sell a 50-mg product, it is easy to see that the patient might take the wrong dosage!"After a pharmacist brought it to our attention, we recalled the batch and tightened up on operator training, SOP detail, and batch-record documentation detail so that it wouldn't recur. Ugly as it was, FDA showed up to make sure we had made the necessary preventive actions and wrote us up for allowing it to happen in the first place."
"You would think an operator could do something as simple as remove a small (1 × 0.25-in.) metal insert, wouldn't you?" growls our GMP Agent-in-Place. "The batch number and expiration date for our blow–fill–seal product are imprinted onto a plastic container by putting a metal insert into each of the 30 mold cavities containing the proper information. These must be replaced for each batch.
"Apparently, the operator either had a problem replacing one metal plate or just never got to it. We produced a batch of more than 100,000 containers with one container in every 30 having the wrong lot number and expiration date. You would think that with filling checks, quality assurance set-up checks, and packaging-line checks that this would have been discovered, but apparently not.
"We recalled the batch and we put in a lot of preventive actions, including more documentation of the insert-replacement activities in the batch record, and including a blank (a formed container that doesn't get filled) in the batch record as a label proof and as another check for the lot number."
New company, new labels, new recall
"Once again, we changed our company name!" exclaims our GMP Agent-in-Place. "It seems we change our name every couple of years just for fun, and for each name change we must change all the product labels, with new logos and color schemas. Label changes were made wholesale, with new masters for every product, every strength, all at once, and the printer was happy to oblige.
"Because the new labels for one product with many dosage strengths looked identical except for the NDC number and potency, the printer evidently made a Master master label, and only changed the variable information. The master labels were received, approved by the appropriate parties, and authorized for printing. Printed copies were received, released, and sent to the line for use. The label bar code check device was set up as usual using the master label.
"Only by happenstance, and only after the first batch was distributed, did we discover that the 2.5-mg product bottle label incorrectly had an identical bar code to the 25-mg product bottle label. The one lot was recalled because some pharmacy customers used the bar code for inventory and potency checks. All the other labels had the correct bar codes when we went back and did a recheck on them."
Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer. If you have a story of clueless operators, oblivious management, inopportune lapses of judgment, or Murphy's Law in action, please send it to Control at [email protected]