• Regulatory NewsRegulatory News

    ICH Proposes Two New Guidelines

    The International Council for Harmonisation (ICH) has announced two new guidelines, with one (M9) providing recommendations to support the biopharmaceutics classification of medicinal products, while the other (M10) applies to the validation of bioanalytical methods and study sample analyses in non-clinical and clinical studies. Both of the new plans for the guidelines are part of efforts to harmonize regional differences in guidance documents and were finalized by ICH ...
  • New Guidance Provides Framework on How to Keep a Drug the Same over Time

    A new draft guidance document released by the US Food and Drug Administration (FDA) is meant to clarify the analytical procedures and methods used to validate the production of drugs and biological products. Background The guidance was last issued in final form in 1987-26 years ago-and in draft form in 2000. Validation procedures and methods are important in the production of pharmaceutical products because they allow a company and regulators to say, with certainty, th...
  • Feature ArticlesFeature Articles

    Establishing Effective Device Supplier Qualifications

    Supplier qualification is an important quality system requirement that, when performed effectively, ensures with a high level of confidence that a purchased product will consistently meet specified requirements. An effective supplier qualification procedure should include risk analysis, quality auditing and the use of qualified analytical test methods and statistical techniques to determine supplier capability. A risk score assigned to suppliers, based on the result of s...
  • EMA Guide on Development of Novel Drug Development Methodologies Released

    The European Medicines Agency (EMA) released a new guidance on 26 January that addresses the development of novel methodologies in drug development, and how EMA develops qualification opinions and advice for scientific methods and protocols. The qualification process is a "new, voluntary scientific pathway leading to either a [Committee for Medicinal Products for Human Use (CHMP)] opinion or a Scientific Advice on innovative methods or drug development tools." The pr...