regulatory compliance

  • Chapter and Verse: USP 621 and You

    By Waters Staff Reading Time: 5 minutes

    In August 2014, the United States Pharmacopeia and the National Formulary (USP-NF) put into effect new guidelines to “allowable adjustments” in its Chapter <621> (USP37-NF32 S1). And as of August 1, 2016 when USP 39 NF 34 S1 goes into effect, for <621> nothing significant has changed since. The USP doesn’t publicize changes to their…

  • Compliance Can Be Complicated, But It Doesn’t Have to Be

    By Laurie Savill Reading Time: 1 minute

    Compliance is required by every regulated industry and in nearly every nation. Whether it’s complying with strict regulations from the United States Food and Drug Administration, the European Directorate for Quality Medicines, or other regulators overseeing a wide range of industries, it’s every company’s responsibility to comply with the regulations and provide the data to…