11.120.10

Procedimiento para la verificación del cumplimiento de las buenas prácticas de manufactura de medicamentos para uso humano (Procedure for the verification of compliance with good manufacturing practices for medicines for human use) (25 pages, in Spanish)

The notified text establishes the regulations governing the process to verify compliance with good manufacturing practices for medicines, with the aim of ensuring the quality of medicines, as one of the factors for the reduction of risks associated with manufacturing. It applies to manufacturing plants belonging to national or foreign laboratories that manufacture or market pharmaceutical products in the national territory, to ensure the quality of medicines.