Home Forums General Discussion Who stores MY stability samples?

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  • joao4515
    Participant
    Post count: 5

    I have worked in various biotech companies, large and small, and the QC department has always stored the stability samples under their custody. I understand this to be the industry norm, if not the standard. An exception would be if I were to have stability samples stored at an offsite facility.

    Is there anyone in a company where the Materials Management department handles storage of stability samples? What was the justification?

    Cheers,

    J

    John O’Neill
    Moderator
    Post count: 73

    I would agree that QC is the most frequent custodian of stability samples, but have thought that this was usually because QC was most often the home organization of the Stability Operations Group. Over the years I have also encountered Stability Groups residing within Pharmaceutical Sciences and Analytical Sciences and they held responsibility for their sample storage. I suppose that Materials Management handling stability sample storage could be acceptable if they met all the requirements of equipment, procedures and training usually found in the QC Stability Groups. In a former life, a site-wide samples handling group was responsible for all movement of samples, but in the long run, handling of stability samples was returned to the responsibility of the QC Stability Group to avoid complicated inventory issues. While QC responsibility makes perfect sense and is the most common practice, maintaining total GMP compliance could be a justification for a different group handling the sample storage. One of the risks might be encountering an inspector who personally believes that the job is solely the responsibility of QC.

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