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Are There Gaps in Labeling Security and Sampling Programs?

May 19, 2010 – 12:56 pm
McNeil Consumer Healthcare’s recent recall of certain children’s products appears to be related to quality issues. And now FDA is widening its investigation. However, I read FDA’s inspection report a few days ago and learned there were some packaging-related observations included, too. It is unclear whether any of these would have been reason enough for a recall. But making note of these observations may serve to educate others in the industry.
For instance, FDA inspectors noted that “strict control is not exercised over labeling issued for use in drug product labeling operations.” Specifically, “labeling was not stored in a locked cage with limited access,” read the report.
The labeling observation intrigues me because strict accounting of label supplies should be part of a company’s error-prevention program as well as a brand security program. But how is this commonly achieved throughout the industry? Are there gaps that need to be addressed? By whom?
Also from the inspection report: “There is no written testing program designed to assess the stability characteristics of drug products.” Specifically, “stability samples collected off of the packaging line for lots . . . were pulled from the beginning of the packaging run. . . . Stability samples are not representative samples from the beginning, middle, and end of the fill run specifically for the three batches with super potent end sample fills.”
I have heard many questions from the industry about sampling, and this observation should serve to address some. Packagers wonder how to develop a statistically sound sampling method. FDA very clearly seems to state that sampling should involve the beginning, middle, and end of a run. Is this enough feedback from FDA–or is a more-specific plan required?

Daphne Allen

  1. One Response to “Are There Gaps in Labeling Security and Sampling Programs?”

  2. Daphne – Interesting observations regarding labeling security. Given the FDA’s broad application of the term “labeling” to include documents such as package inserts and IFUs, as well as labels that are applied to finished goods, did the report provide any details in that regard?

    Another thing that jumps out at me is that the quote you excerpted would seem to imply McNeil was/is pre-printing finished good labels well in advance of applying them to products. Otherwise, the only risk of unsecured labeling supplies is pilfery; akin to stealing pens from the office supply cabinet, which is hardly a regulatory issue. In other words, a strict accounting of labeling supplies should only be a regulatory concern once they are printed as finished good labels ready for application.

    Thus, I think the real question – which may or may not apply to the McNeil situation – is if there are gaps in identification and reconciliation of printed product labels within pharma and device manufacturing environments. And, the answer is yes.

    In my humble experience, reconciliation of printed labels is most commonly achieved with manual reporting by shop-floor personnel at the end of a production run (i.e. X total labels printed, of which X were applied to product and X were scrapped). As you might imagine, the risk of human error is significant, as is the risk of diversion for counterfeiting purposes.

    By Patrick Kearney on Jun 23, 2010

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