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Regulation of the Indonesian Food and Drug Authority no. 34 of 2018 on guidelines for good manufacturing practice for drugs.

Pays/Territoire
Indonésie
Type du document
Règlement
Date
2018
Source
FAO, FAOLEX
Source d'origine
Official Gazette of the Republic of Indonesia no. 1600 of 2018.
Sujet
Bétail, Alimentation et nutrition
Mot clé
Hygiène/procédures sanitaires Commerce/industrie/sociétés Éducation Santé publique Transport/dépôt Évaluation/gestion des risques Sous-produits animaux Santé des animaux
Aire géographique
Asie, Asie et Pacifique, East Asian Seas, Océan Indien, Asie du Sud-Est
Entry into force notes
7 December 2018.
Résumé

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.

Texte intégral
Indonésien/Anglais
Site web
peraturan.go.id