Tag: ANVISA

  • Regulatory Inspection Management in Pharmaceutical Company

    Regulatory Inspection Management in Pharmaceutical Company

    Pharmaceutical companies are governed by regulations and thus regulatory inspection management is very important for pharmaceutical companies. They must follow the regulations and/or regulatory guidelines of the country where they are authorized to sell their products. Generally, the regulatory authority inspects the manufacturing site of the pharmaceutical company before giving a manufacturing license or approving…

  • Specific Regulatory Requirements of ANVISA for Analytical Method Validation

    Specific Regulatory Requirements of ANVISA for Analytical Method Validation

    The requirements for analytical method validation which are listed in “ANVISA RDC 166/2017-Validation of Analytical Methods” and “ANVISA RDC 53/2015- Guide on notification, identification, and qualification of degradation products in medicinal products,” and are going beyond those defined in ICH Q2(R1), FDA guidance for Industry and relevant chapters of USP, EP and JP are summarized…