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    Month: September 2020

    Internationally Recognized Stability Criteria

    With the 2019 revision to <797>, the USP eliminated the ability to extend Beyond Use Dates (BUDs) using stability indicating methods, citing there was more…

    Seth DePasquale, R.Ph., BCSCP September 5, 2020
    0 Comments

    483 #3 – Smoke Studies and Media Fills

    Learning Objectives Explain the purpose of smoke studies Define the two types of smoke studies that need to be performed Explain the two conditions under…

    Seth DePasquale, R.Ph., BCSCP September 3, 2020
    2 Comments

    Recent Posts

    • FDA 483 #10 – Non-Viable Particle Counting
    • FDA 483 #9 – Bacterial Endotoxin Testing
    • Pharmacy Inspection Podcast – Episode 48 – Can we share stability studies?
    • Can we share Stability Studies?
    • FDA 483 #8 – Using ungraded ingredients

    Recent Comments

    • Bret Snow on You received a 483? Don’t Panic…
    • Rick Meyer on Pharmacy Inspection Podcast – Episode 44 – Is my building right for my compounding pharmacy?
    • Seth DePasquale, R.Ph., BCSCP on Cleaning up Confusion; correctly cleaning your room
    • Rick Meyer on Pharmacy Inspection Podcast – Episode 46 – HEPA Filtered Exhaust
    • Seth on 483 #3 – Smoke Studies and Media Fills
    © 2025 - Sterile.AF
    483 #3 - Smoke Studies and Media Fills

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