Regulatory Open Forum

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  • 1.  Stability study data

    Posted 22-Mar-2023 10:56

    What is the common industry practice if one of your stability studies shows that the data on your labels needs an update?

    What steps are recommended?

    Noopur Gupta, PhD | Director, Regulatory Affairs – Blood Gas products | Radiometer Medical ApS
    Åkandevej 21 | 2700 Brønshøj |

  • 2.  RE: Stability study data

    Posted 22-Mar-2023 12:10

    In short, if the erroneous / outdated / violative / incorrect expiry date (or other related data on the label) are within reasonable risk acceptance criteria (safety, performance, regulatory), then such product can be accepted as-is and left alone.  But if the risk acceptance criteria are exceeded, then corrective measures are needed to eliminate the nonconformity.  Such corrective measures would typically include relabeling and/or removal/recall.

    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

  • 3.  RE: Stability study data

    Posted 23-Mar-2023 08:29

    Hello Noopur,

    As Kevin mentioned this is usually within acceptable risk as most products with shelf-life dates or expiration dates are much longer than the product would remain in a warehouse storage location or on a customer's shelf.  In fact, a common industry practice is to have a defined "short sale date" where the product would not be sold with say less than 1 year on the shelf-life/expiration.  Probably the most important part of this is to clearly document everything, rationale, justification, and actions which are taken.  If the quality system has an adjustment process (like deviations) or change control process, this can be documented with current actions being started.  It may even be documented through a corrective action process where the root cause and corrective action (plan) is defined.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs