Methods Validation Clause Samples
The Methods Validation clause establishes the requirement for verifying and documenting that specific procedures, processes, or analytical methods used in a project or operation consistently produce reliable and accurate results. In practice, this clause typically applies to scientific, technical, or manufacturing contexts where methods must be tested against predefined criteria to ensure their suitability for intended purposes. By mandating such validation, the clause helps ensure quality control, regulatory compliance, and confidence in the results generated, thereby reducing the risk of errors or unreliable outcomes.
Methods Validation. Genchem Pharma shall cause Sicor to validate Anthra's regulatory methods for ***, as set forth in the CMCs for the United States and the European Union, and shall cause Sicor to use such assays as the basis for all AD32 release and stability testing.
Methods Validation. 5.9.1 ORPHAN is responsible for providing to LONZA approved copies of the most current and complete filed analytical methods relating to the PRODUCT for receipt of API and raw materials, in-process product testing, product lot release, and drug and product stability and cleaning validation.
5.9.2 ORPHAN is responsible for providing to LONZA a Certification of Methods Validation for all critical methods practiced by LONZA (raw materials testing, in-process product testing, product lot release, and drug and product stability) . The certifications should state, “The methods are appropriate for the intended purpose, are validated per relevant regulatory guidelines, and are readily available in case of a regulatory inspection.”
Methods Validation. Accelerated stabilities on development batches
Methods Validation. For those analytical methods to be provided by XANODYNE, XANODYNE shall be responsible for providing to DSM approved copies of the current and complete regulatory filed analytical methods and supporting validation documentation relating to the Products, for application by DSM in the production process, including receipt of API and raw materials, in-process product testing, product batch release, drug and product stability, and cleaning validation.
Methods Validation. For those analytical methods to be provided by AMAG, AMAG shall be responsible for providing to DPI approved copies of the current and complete regulatory filed analytical methods and supporting validation documentation relating to the Products for application by DPI in the production process, including receipt of API and raw materials, in-process product testing, product batch release, drug and product stability, and cleaning validation.