Kamis, Juni 22, 2023

BPOM Stipulates Qualifications for Suppliers of Drugs Ingredients

The Head of the National Agency for Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") has issued Circular No. 5 of 2023 ("Circular 5/2023") on Qualifications for Suppliers of Drug Ingredients ("Suppliers"), which has been in force since 29 May 2023.
The fulfillment of qualifications by Suppliers encompasses criteria, selection, stipulation and the maintenance of supplies. In this regard, Circular 5/2023 states that any pharmaceutical companies, including their branches, that organize procurements, storage and the distribution of drug ingredients must secure various qualifications as Suppliers. Said qualifications include the following, among others: 1) Must secure relevant licenses from the government, especially in relation to good practices for the manufacture and distribution of drugs; 2) Must satisfy various pharmaceutical grade standards that apply to drug ingredients; and 3) Must implement risk controls in order to ensure the quality of all manufactured and distributed drugs.
It should also be noted during the implementation of their business activities, Suppliers must comply with the following legal frameworks: 1) Regulation of BPOM No. 34 of 2018 on Good Manufacturing Guidelines for Drugs; and 2) Regulation of BPOM No. 9 of 2019 on Technical Guidelines for Good Distribution Practices for Drugs, as amended by Regulation of BPOM No. 6 of 2020.

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The Head of the National Agency for Drug and Food Control (Badan Pengawas Obat dan Makanan – "BPOM") has issued Circular No. 5 of 2023 ("Circular 5/2023") on Qualifications for Suppliers of Drug Ingredients ("Suppliers"), which has been in force since 29 May 2023.
The fulfillment of qualifications by Suppliers encompasses criteria, selection, stipulation and the maintenance of supplies. In this regard, Circular 5/2023 states that any pharmaceutical companies, including their branches, that organize procurements, storage and the distribution of drug ingredients must secure various qualifications as Suppliers. Said qualifications include the following, among others: 1) Must secure relevant licenses from the government, especially in relation to good practices for the manufacture and distribution of drugs; 2) Must satisfy various pharmaceutical grade standards that apply to drug ingredients; and 3) Must implement risk controls in order to ensure the quality of all manufactured and distributed drugs.
It should also be noted during the implementation of their business activities, Suppliers must comply with the following legal frameworks: 1) Regulation of BPOM No. 34 of 2018 on Good Manufacturing Guidelines for Drugs; and 2) Regulation of BPOM No. 9 of 2019 on Technical Guidelines for Good Distribution Practices for Drugs, as amended by Regulation of BPOM No. 6 of 2020.

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