Indonesia Clarifies GMP Certification Procedures

The certification documents of GMP are divided into GMP Certificate and Fulfillment Certificate for GMP Aspects. The difference between applying for these certification documents is the GMP quality system implementation degree.

Cosmetic enterprises in Indonesia in conducting production activities are obliged to comply with GMP Guideline. The application of the GMP Guideline is proved by GMP certification documents. On Dec. 1, 2020, Indonesia BPOM released a new draft regulation, Certification Procedures of Cosmetic Good Manufacturing Practices, clarifying the types of GMP certification documents, the required documents for GMP certification, the certification process, certification renewal and modification ^[1].

GMP Certification Documents Types

The certification documents are divided into GMP Certificate and Fulfillment Certificate for GMP Aspects. They are issued by BPOM and are valid for 5 years.

1) GMP Certificate

Enterprises that have been contracted to produce cosmetics need to prove their GMP implementation status with a GMP Certificate.

2) Fulfillment Certificate for GMP Aspects

Enterprises that have not yet been contracted to produce cosmetics need to prove their GMP compliance status with either a GMP Certificate or a Fulfillment Certificate for GMP Aspects.

There are 2 categories of Fulfillment Certificate for GMP Aspects.

Class A Gradual Fulfillment Certificate for GMP Aspects (for enterprises with Class A production license); or
Class B Fulfillment Certificate for GMP Aspects (for enterprises with Class B production license).

Types of cosmetics intended to be produced must be stated on the GMP Certificate or Fulfillment Certificate for GMP Aspects. Cosmetics enterprises are prohibited from producing cosmetics outside the types stated in the GMP Certificate or Fulfillment Certificate for GMP Aspects.

Determination principles of cosmetic types for GMP Certification can refer to ChemLinked coslist.

Required Documents for GMP Certification

Documents necessary for obtaining GMP certificate and Fulfillment Certificate for GMP Aspects are listed in the following table. The difference between applying for these GMP certification documents is the GMP quality system implementation degree.

Documents		GMP Certificate	Class A Gradual Fulfillment Certificate for GMP Aspects	Class B Fulfillment Certificate for GMP Aspects
Administrative Documents	Application letter	√	√	√
	Proof of payment of non-tax revenue	√	√	√
	Approval for building plans for the cosmetics industry	√	√	√
Technical Documents	GMP quality system implementation documents covering 12 aspects of general requirements, personnel, buildings and facilities, equipment, sanitation and hygiene, production, quality control, documentation, internal audit, storage, production and testing contracts, complaints handling, and product withdrawals	√
	GMP quality system implementation documents covering aspects of personnel, building and facilities, equipment, sanitation and hygiene, production, quality control, documentation, and storage		√
	GMP quality system implementation documents covering aspects of sanitation and hygiene, and documentation			√
	A valid approval letter for the use of shared facilities between cosmetics and medicines or traditional medicines	√	√	√
	Has a technical person in charge	√	√	√

GMP Certification Procedures

Source: Regulation for Electronic Business Licensing of Drug and Food

Explanations of Class A and B Production Licenses

All cosmetic manufacturers must obtain a production license before manufacturing cosmetics in Indonesia. Production license is divided into two categories by cosmetic forms and types:

Class A Production License grants rights to manufacture all forms and types of cosmetics.
Class B Production License grants restricted rights confined to the manufacture of certain forms and types of cosmetics with low risks or are made with simple technologies. Find permitted cosmetic forms and types for Class B Production License here.