[Updated] Indonesia Proposes to Update Cosmetic GMP Certification Application and Renewal Requirements

Terms:

Good Manufacturing Practices (GMP) aim to ensure that the products produced always meet the quality requirements set out in accordance with their intended use. GMP cover all aspects of cosmetic manufacturing activities;
GMP certificate is a legal document serving as a proof that the cosmetic enterprise has fully implemented GMP in the manufacture of cosmetics;
Certificate of GMP Fulfillment is a legal document serving as a proof that the cosmetic enterprise has gradually implemented GMP. The certificate of fulfillment is divided into Class A and Class B. Class A is applicable to enterprises that can produce all types of cosmetics, while Class B is applicable to enterprises that can only produce certain types of cosmetics. Class A requires enterprises to comply with requirements for 10 aspects in GMP, while the Class B requires enterprises to comply with requirements for 2 aspects in GMP.

Editor's note: This article was originally published on November 11, 2024, and was updated on December 13, 2024, as per the latest developments. The updated contents are marked in green below.

On December 11, 2024, Indonesia released the second draft of the Technical Requirements for Cosmetic Good Manufacturing Practices (GMP) Certification. ¹ Compared to the first draft, the second draft reflects minimal changes. The key update clarifies BPOM’s review timeframe for applications related to the GMP fulfillment certificate, as well as for renewals and modifications, which must be completed within 7 working days.

On November 5, 2024, BPOM released a draft of the Technical Requirements for Cosmetic Good Manufacturing Practices (GMP) Certification for public consultation. ²

Key Proposed Amendments

1. Changes to required documents and the verification period for application submissions

The draft proposes the following changes to the required documents and the verification timeline for GMP certifications:

1) Cancellation of some documents:

The requirement of building plan approval for cosmetics facilities and valid approval letters for shared facilities (between cosmetics and medicines or traditional medicines) is removed for the GMP certificate and GMP fulfillment certificate applications. However, for the Class B certificate of GMP fulfillment, approval for building plan remains mandatory.

Required Application Documents		GMP Certificate	Class A Certificate of GMP Fulfillment	Class B Certificate of GMP Fulfillment
Administrative Documents	Application letter	√	√	√
Technical Documents	GMP quality system implementation documents covering 12 aspects of requirements, including 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 recalls.	√
	GMP quality system implementation documents covering 10 aspects of requirements, including quality management system, personnel, building and facilities, equipment, sanitation and hygiene, production, quality control, documentation, storage, compliant handling and product recalls.		√
	GMP quality system implementation documents covering 2 aspects of requirements, including sanitation and hygiene, and documentation.			√
	Approval for building plans for the cosmetics enterprise	Not required anymore	Not required anymore	√
	A valid approval letter for the use of shared facilities between cosmetics and medicines or traditional medicines	Not required anymore	Not required anymore	Not required anymore
	Has a technical person in charge	√	√	√

2) Verification time limits:

For GMP certificate applications, the review period for application letter is extended from 3 working days to 7 working days after document upload;
The requirement of BPOM to verify application letters for GMP fulfillment certificates within 3 working days has been removed.

2. Revised requirements for GMP certificate renewal

1) The GMP certificate and GMP fulfillment certificate are valid for five years and can be renewed. The draft changes the renewal application deadline from three months to six months before expiration. To be specific, applications must be submitted no later than six months prior to the certificate's expiration. If the six-month deadline is missed, a new certificate application is required.

2) For Class A GMP fulfillment certificates, the current process allows for two times of renewals, but the draft proposes only allows renewal to happen one time.

3) During the renewal, facility inspection is required if changes in production capacity is accompanied by additional room and changes in cleanliness level. The draft adds new situations where facility inspection is not required during the renewal (marked in red):

There are no changes in production capacity, room function, or warehouse;
There is additional production capacity with changes in equipment or room function, but no changes in cleanliness level;
An additional warehouse is added outside the facility's registered address;
An additional warehouse is located at the same facility.

4) The requirement of BPOM to verify renewal application letters for GMP certificate and GMP fulfillment certificate within 3 working days has been removed.

Additionally, the draft clarifies the application process and required documents for obtaining approval to use joint cosmetic production facilities with quasi-drugs or household health supplies.