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Revista Cubana de Farmacia

versión impresa ISSN 0034-7515versión On-line ISSN 1561-2988

Resumen

MONTES DE OCA, Nivian; VILLOCH CAMBAS, Alejandra  y  ROQUE PINERO, Esnayra. Methodology to design the Master Plan of Validation of production processes of National Center of Agricultural Health. Rev Cubana Farm [online]. 2010, vol.44, n.2, pp.144-152. ISSN 0034-7515.

The methodology to design the Validation Master Plan the production processes of National Center of Agricultural Health was created from the requirements present in the Regulation 16, 2006 of Good Practices of drugs manufacture including the organization policy for validation activity of its organizing structure, installations, systems, equipments and processes to be validated, documentation format used, planning and calendar of each activity; the results from each protocol performed, the generating changes control, abstract of prior validations, fulfillment of proposed plan, conclusions where are determined in a summarized way if the validated processes are under control, the more relevant results, as well as how the corrective and preventive actions executed, and lastly, the distribution of all the generated information is defined, thus creating the validation of Master Plan. This validation system is showed thorough procedures, protocols and registries applied in manufacturing process of Surfacen® a human use drug manufactured in the National Center of Agricultural Health.

Palabras clave : Surfacen; pulmonary surfactant; processes validation; Validation Master Plan.

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