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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