GMP in Indonesia: Regulator BPOM introduces ‘Gradual Fulfilment Certificate’ to enhance cosmetics manufacturing practices

By Amanda Lim contact

- Last updated on GMT

BPOM has introduced a new Gradual Fulfilment Certificate for cosmetic companies. [GettyImages]
BPOM has introduced a new Gradual Fulfilment Certificate for cosmetic companies. [GettyImages]

Related tags: Indonesia, Regulation, GMP

Indonesian regulator the National Agency of Drug and Food Control (BPOM) has introduced a new Gradual Fulfilment Certificate for cosmetic companies to prove they will obtain Good Manufacturing Practices (GMP) certification.

BPOM has released​ the draft amendments to the Guideline for Cosmetic Good Manufacturing Practice​ for public consultation.

According to the document, the guidelines were revised “in order to obtain cosmetics that meet quality requirements, the GMP guidelines need to be adjusted to keep up with the development of science and technology.”

Cosmetic enterprises in Indonesia are obliged to conduct production activities according to the GMP guidelines.

According to the draft, enterprises that have been contracted to produce cosmetic products need to prove their GMP compliance and implementation status with a GMP Certificate, known locally as the Cara Pembuatan Kosmetika Yang Biak (CPKB) certificate. The GMP certificate has a five-year validity.

However, enterprises that do not have an existing contract to produce cosmetic products should have either a GMP Certificate or the newly introduced Gradual Fulfilment Certificate for GMP.

Hedy He, regulatory analyst at Chemlinked​ explained that the Gradual Fulfilment Certificate for GMP was a document proving that the cosmetic enterprises would gradually implement GMP. This certificate would be valid for five years.

Furthermore, the draft also includes GMP Guideline operational instructions, clarifying the detailed requirements for implementing GMP for aspects including personnel, sanitation and hygiene, production, and complaints handling and product withdrawals.

He said the new draft integrated the GMP guidelines and the operational instructions, ensuring that the guidelines are more comprehensive, complete and convenient for the cosmetics industry to refer to.

Improving efficiency

In addition, BPOM released and implemented the Regulation for the Determination of Forms of Cosmetic Preparations.

The regulation was formulated to facilitate the determination of the forms of cosmetic preparations in public services, especially for GMP certification.

Enterprises can determine the cosmetic preparations forms according to the table in the regulation, so as to improve the efficiency of the public services. It is more convenient to determine cosmetic forms in public services and speed up service efficiency,​said He.

In May this year, BPOM laid out its goals​ under its strategic plan for 2020-2024

Among its goals, the authority aims to have 82% of cosmetics meeting the safety and quality requirements.

It also intends to help 84% cosmetic enterprises with compliant facilities and 89% cosmetics with GMP certificates.

Furthermore, it expects to have 81% of micro-, small- and medium-sized enterprises in cosmetics, traditional medicines and food production to meet safety and quality standards by 2024.

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