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What is NOM-059-SSA1-2015: Medications GMP Standards about?

NOM-059-SSA1-2015 establishes mandatory requirements for the manufacturing of medications for human use in Mexico, focusing on quality management and good manufacturing practices (GMP). It outlines definitions, classifications of biosecurity levels, and the necessary documentation for maintaining quality throughout the manufacturing process. The standard emphasizes the importance of controlling contamination, ensuring safety, and managing risks associated with the production of pharmaceuticals.

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EN