5. Stability Studies - EFRAC | Drug, Food, Gas, Proficiency Testing Laboratory

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    Molecules deemed promising as Probable Candidates for API/ Pharmaceutical Formulation during the Drug Discovery Process are exposed to Stability Testing, which is Integral to the development of New Drug Candidates i.e., APIs and Pharmaceutical Formulations/Products for establishing their Shelf Life or Expiry Date. It is advisable to Study the possible Influence or Interaction of Packaging Material and Drug Products during their Shelf Life Period.

    It is also important during Routine Manufacturing Process to monitor Product Quality with respect to Time and Environmental Conditions.

    As per ICH Guidelines, EFRAC’s Stability Storage Facility is equipped with Stability Chambers equipped with Online Temperature and RH Data Recording, Auto Alarm, and Mobile Text Warning Facilities and is compliant with 21 CFR Part 11 Requirements. EFRAC covers a wide range of Environmental Conditions like:

    Refrigerated Condition 5°C

    Primary ICH Long Term Condition (For Zone I to II) 25°C/ 60% R.H

    Intermediate ICH Condition (For Zone Ivb)  30°C / 75% RH

    Intermediate ICH Condition (For Zone I to Iva) 30°C / 60% RH

    At EFRAC we tries to deliver the best quality services to our customers. Our innovative and strategic layouts are designed to guide the global Pharma industries towards guaranteed Product Safety, Superior Quality at minimized risks.

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    Pharma Specialized Services ………........ Stability Studies