The Federal Commission for the Protection against Health Risks (COFEPRIS) published a Catalogue of Criteria and Requirements establishing the regulatory framework for submitting samples of medicinal products, biological products, vaccines, and active pharmaceutical ingredients (APIs) for laboratory analysis. The document outlines documentation requirements, analytical protocols, packaging and cold chain conditions, and acceptance criteria applicable to submissions processed by the Analytical Control and Coverage Expansion Commission (CCAYAC). The guidance aims to standardize sample submission processes, ensure analytical reliability, and strengthen regulatory compliance within accredited laboratories supporting market surveillance and quality control activities.
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