Regulation of the Indonesian Food and Drug Authority no. 34 of 2018 on guidelines for good manufacturing practice for drugs. País/Territorio Indonesia Tipo de documento Reglamento Fecha 2018 Fuente FAO, FAOLEX Fuente original Official Gazette of the Republic of Indonesia no. 1600 of 2018. Materia Ganado, Alimentación y nutrición Palabra clave Higiene/procedimientos sanitarios Negocios/industria/corporaciones Educación Salud pública Transporte/depósito Evaluación/manejo de riesgos Subproductos animales Sanidad animal Área geográphica Asia, Asia y Pacifico, Mares del Asia Oriental, Océano Índico, Asia Sudoriental Entry into force notes 7 December 2018. Resumen This Regulation concerns the necessary standards and the good practices for drug manufacturing in the country. The Regulation defines: pharmaceutical industry; good manufacturing practice; drug, as a combination of materials, including biological products, used to influence or explore physiological system or pathological state, in order to determine diagnosis,, healing, recovery, health improvement and contraception to human; storage and transport of drugs; use of ionising radiations in drugs manufacturing; quality risk management; procedures for the imposition of administrative sanctions in case of misconduct. The Attachment details and specifies the guidelines for good manufacturing practice, including measures for personnel education and training; hygiene and sanitary requirements for both staff and building and premises; packaging; use of animal species in the manufacture of drugs; animal health information. Texto completo Inglés/Indonesio Página web peraturan.go.id