Indonesia Unveils Determination Principles of Cosmetic Preparation Forms and to Amend the GMP Guideline

The regulation is formulated to facilitate the determination of the forms of cosmetic preparations in public services, especially for GMP certification. The draft amendments to Guideline for Cosmetic Good Manufacturing Practice include the introduction of Gradual Fulfillment Certificate for GMP and the inclusion of GMP Guideline operational instructions.

On September 28, 2020, Indonesia BPOM released and implemented the Regulation for the Determination of Forms of Cosmetic Preparations ^[1]. Following that, Indonesia released the draft amendments to Guideline for Cosmetic Good Manufacturing Practice for public consultation ^[2].

1. Regulation for the Determination of Forms of Cosmetic Preparations

This regulation is formulated to facilitate the determination of the form of cosmetic preparations in public services, especially GMP certification. Enterprises can determine the cosmetic preparations forms according to the following table.

No.	Cosmetic Preparation Forms	Cosmetic Preparation Types
1	Solid	Bath soap bar Shampoo bar Lotion bar Eyebrow pencil Lipstick Lip liner Pencil stick Deodorant stick Foundation stick Fragrance Cold powder Other solid preparations that meet the safety, efficacy, and quality standard
2	Powder	Powder Compact powder Scrub Mangir Bath salts Other powder preparations that meet the safety, efficacy, and quality standard
3	Semi-solid	Cream Gel Paste Pomade Other semi-solid preparations that meet the safety, efficacy, and quality standard
4	Liquid	Liquid Viscous liquid Suspension Other liquid preparations that meet the safety, efficacy, and quality standard
5	Aerosol	Aerosol Other aerosol preparations that meet the safety, efficacy, and quality standard

2. Draft Amendments to Guideline for Cosmetic Good Manufacturing Practice

The main amendments are:

1) Introduce the new concept of "Gradual Fulfillment Certificate for GMP"

Cosmetic enterprises in Indonesia in conducting production activities are obliged to comply with GMP Guideline. Enterprises receiving a production contract need to prove their GMP compliance/implementation status with a GMP Certificate, while enterprises that do not receive a production contract should have a GMP Certificate or a Gradual Fulfillment Certificate for GMP.

Gradual Fulfillment Certificate for GMP is a document proving that the cosmetic enterprises will gradually implement GMP. The certificate is valid for five years.

Visit ChemLinked coslist to find the required information for applying for GMP certificate.

2) Include the content of Operational Instructions of GMP Guideline

The operational instructions clarify the detailed requirements for implementing GMP in the following aspects:

General requirements
Personnel
Buildings and facilities
Equipment
Sanitation and hygiene
Production
Quality control
Internal audit
Storage
Production and testing contracts
Complaints handling and product withdrawals