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in hospitals and facilities that engage in the provision of radiopharmaceutical (radiofarmaka) materials have now been repealed and replaced.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]