Home Forums General Discussion In-use stability testing single unit dose injectable

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  • Neok_007
    Participant
    Post count: 1

    Is sterility testing part of the testing panel to establish an in-use shelf life for a single unit dose injectable after reconstitution. EMA guidance and Q&A speaks of verifying chemical and physical stability, but only refers to microbiological stability in terms of “using reconstitution methods precluding microbial contamination”. In other words, does it make sense to test for sterility in an artificial setting that might not 100% reflect the hospital pharmacy setting, e.g. no laminar flow available for aseptic reconstitution?

    Walter Routh
    Moderator
    Post count: 37

    If the label states to use immediately I would think that should not require any micro support or even any routine stability on recon material, but still, that should be justified in the filing, which shouldn’t be too hard to do, especially for the reasons you give in your question. EMA’s in-use guideline states “The appropriate physical, chemical and microbial properties of the product susceptible to change during storage should be determined over the period of the proposed in-use shelf life.” First point on this is that it can be interpreted to only apply to material not labeled for immediate use after reconstitution. Second, the words “appropriate” and “susceptible to change” seem to give room for justifications if micro/sterility testing doesn’t make sense. I agree that it doesn’t make sense for an in-use stability study on non-sterile products mimicking non-sterile use to include micro and sterility testing, especially if anti-microbial effectiveness is in parallel. Still, any decision will need to be justified. If your label claim states the reconstituted material is good for a specific time/condition then the conservative approach would be to support that material via routine stability to show, at least in a sterile laboratory environment, that it does not promote microbial growth during that recon period. But there must be a several scenarios where not doing micro testing in this routine stability setting would be justified–such as a very short recon stability, or anti-microbial effectiveness tested on the non-recon material, etc.

    John O’Neill
    Moderator
    Post count: 73

    I would agree with Walter, but add that your decision and justification should get some documented agreement from the fine folks in your Microbiology, Quality Assurance and Regulatory Affairs departments. If down the line, your decision gets rejected by some agency, you don’t want to bear the blame alone.

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