Selasa, Oktober 26, 2021

BPOM Introduces New Good Practice Guidelines for the Production of Traditional Medicines

The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan - "BPOM") has issued Regulation No. 25 of 2021 on the Implementation of Good Practice During the Production of Traditional Medicines ("Regulation 25/2021"). The implementation of Good Practice During the Production of Traditional Medicines (Cara Pembuatan Obat Tradisional yang Baik – “CPOTB”), as addressed under this regulation, applies to the following parties: 1) Traditional Medicines Industries ("IOT"); and 2) Natural Extract Industries ("IEBA").
During the production of traditional medicines, IOT and IEBA are required to implement the CPOTB, which encompass the following elements: 1) IOT quality systems; 2) Personnel; 3) Buildings and capacities; 4) Equipment; 5) Production; 6) Storage and shipment; 7) Quality control; 8) Self-inspections, quality audits and supplier approval audits; 9) Complaints and product returns; 10) Documentation; 11) Outsourcing activities; 12) Qualification and validation; 13) Computerized systems; 14) Production methods for traditional medicines that utilize active ingredients; 15) Comparative and residual samples (sampel pembanding dan pertinggal); and 16) Quality risk management. Details of the CPOTB are comprehensively addressed under the Appendix to Regulation 25/2021.
Furthermore, IOT and IEBA are required to secure CPOTB certification as proof of the implementation of the CPOTB. Said certification is issued by the Head of the BPOM in accordance with the prevailing laws and regulations. Failure to implement the CPOTB during the production of any traditional medicines will result in the imposition of administrative sanctions upon the IOT and/or IEBA in question.
Regulation 25/2021 has been in force since 14 October 2021.

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The National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan - "BPOM") has issued Regulation No. 25 of 2021 on the Implementation of Good Practice During the Production of Traditional Medicines ("Regulation 25/2021"). The implementation of Good Practice During the Production of Traditional Medicines (Cara Pembuatan Obat Tradisional yang Baik – “CPOTB”), as addressed under this regulation, applies to the following parties: 1) Traditional Medicines Industries ("IOT"); and 2) Natural Extract Industries ("IEBA").
During the production of traditional medicines, IOT and IEBA are required to implement the CPOTB, which encompass the following elements: 1) IOT quality systems; 2) Personnel; 3) Buildings and capacities; 4) Equipment; 5) Production; 6) Storage and shipment; 7) Quality control; 8) Self-inspections, quality audits and supplier approval audits; 9) Complaints and product returns; 10) Documentation; 11) Outsourcing activities; 12) Qualification and validation; 13) Computerized systems; 14) Production methods for traditional medicines that utilize active ingredients; 15) Comparative and residual samples (sampel pembanding dan pertinggal); and 16) Quality risk management. Details of the CPOTB are comprehensively addressed under the Appendix to Regulation 25/2021.
Furthermore, IOT and IEBA are required to secure CPOTB certification as proof of the implementation of the CPOTB. Said certification is issued by the Head of the BPOM in accordance with the prevailing laws and regulations. Failure to implement the CPOTB during the production of any traditional medicines will result in the imposition of administrative sanctions upon the IOT and/or IEBA in question.
Regulation 25/2021 has been in force since 14 October 2021.

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