BPOM Updates CPOB Guidelines for Hospitals

The National Agency of Drug and Food Control (Badang Pengawas Obat dan Makanan – “BPOM”) has issued Regulation No. 12 of 2022 on Guidelines for Good Drug Manufacturing Practices (Cara Pembuatan Obat yang Baik – “CPOB”) in Hospitals (“Regulation 12/2022”). These matters were previously addressed under Regulation of the BPOM No. 34 of 2018 (“Regulation 34/2018”), which set out a comprehensive set of CPOB guidelines that applied to all pharmaceutical industries and facilities and that addressed the manufacture of drugs and drugs materials.[1] However, through the issuance of Regulation 12/2022, all provisions that address CPOB in pharmaceutical installations in hospitals and facilities that engage in the provision of radiopharmaceutical (radiofarmaka) materials have now been repealed and replaced.[2]