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

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.