Rabu, Januari 25, 2023

BPOM Set to Revise Good Manufacturing Practices for Drugs Guidelines

In an effort to ensure that the applicable guidelines for Good Manufacturing Practices for Drugs (Cara Pembuatan Obat yang Baik – "CPOB") are in line with current scientific and technological developments, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing a Draft Regulation ("Draft Regulation") that will adjust some of the provisions originally set out under the CPOB guidelines ("Guidelines"), as previously addressed under Regulation of the BPOM No. 34 of 2018 ("Regulation 34/2018")
In addition to being applicable to pharmaceutical industries ("Industries") that engage in the production of drugs and/or drug materials (collectively referred to as "Drugs"), the Guidelines will also be applicable to institutions that produce radiopharmaceutical materials and that have secured considerations from the Nuclear Energy Supervisory Agency (Badan Pengawas Tenaga Tenaga Nuklir/BAPETEN). However, facilities that produce radiopharmaceutical materials for use in hospitals are exempted from compliance with the Guidelines, as said facilities should refer to the applicable CPOB for hospital guidelines.
In terms of the matters that have been outlined under the Guidelines, the Draft Regulation is set to address a total of 27 matters relating to CPOB (in comparison, Regulation 34/2018 currently only addresses 25 such matters). These matters now encompass: 1) The management of narcotics, psychotropics and pharmaceutical precursors; and 2) The manufacture of high-level therapeutic products; and 3) The manufacture of active biological materials and products.

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In an effort to ensure that the applicable guidelines for Good Manufacturing Practices for Drugs (Cara Pembuatan Obat yang Baik – "CPOB") are in line with current scientific and technological developments, the National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") is currently preparing a Draft Regulation ("Draft Regulation") that will adjust some of the provisions originally set out under the CPOB guidelines ("Guidelines"), as previously addressed under Regulation of the BPOM No. 34 of 2018 ("Regulation 34/2018")
In addition to being applicable to pharmaceutical industries ("Industries") that engage in the production of drugs and/or drug materials (collectively referred to as "Drugs"), the Guidelines will also be applicable to institutions that produce radiopharmaceutical materials and that have secured considerations from the Nuclear Energy Supervisory Agency (Badan Pengawas Tenaga Tenaga Nuklir/BAPETEN). However, facilities that produce radiopharmaceutical materials for use in hospitals are exempted from compliance with the Guidelines, as said facilities should refer to the applicable CPOB for hospital guidelines.
In terms of the matters that have been outlined under the Guidelines, the Draft Regulation is set to address a total of 27 matters relating to CPOB (in comparison, Regulation 34/2018 currently only addresses 25 such matters). These matters now encompass: 1) The management of narcotics, psychotropics and pharmaceutical precursors; and 2) The manufacture of high-level therapeutic products; and 3) The manufacture of active biological materials and products.

......