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

Country/Territory
Indonesia
Document type
Regulation
Date
2018
Source
FAO, FAOLEX
Original source
Official Gazette of the Republic of Indonesia no. 1600 of 2018.
Subject
Livestock, Food & nutrition
Keyword
Hygiene/sanitary procedures Business/industry/corporations Education Public health Transport/storage Risk assessment/management Animal by-products Animal health
Geographical area
Asia, Asia and the Pacific, East Asian Seas, Indian Ocean, South-Eastern Asia
Entry into force notes
7 December 2018.
Abstract

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.

Full text
English/Indonesian
Website
peraturan.go.id