What are the requirements for a Good Manufacturing Practice (GMP) Certificate for Cosmetics for the Cosmetics Industry located in ASEAN countries?
It can be in the form of a GMP certificate or a Statement of GMP Implementation, with the following conditions:
- The remaining validity period is at least 6 months before the certificate or statement expires.
- If the validity period is more than 5 years or does not include a validity period, the certificate or statement is valid for 5 years from the date of issue.
What are the general requirements for a Good Manufacturing Practice (GMP) Certificate for Cosmetics for the Cosmetics Industry located outside ASEAN countries and the Cosmetics Industry outside Indonesia that accepts production contracts?
The GMP certificate for the Cosmetics Industry located outside ASEAN countries and the Cosmetics Industry outside Indonesia that accepts production contracts must meet the following conditions:
- a. Issued by authorized government officials or recognized institutions in the country of origin;
- b. Legalized by the local Indonesian Embassy/Consulate General;
- c. The remaining validity period is at least 6 months before the certificate expires;
- d. If the validity period is more than 5 years or does not include a validity period, the certificate is valid for 5 years from the date of issue.
In the event that the conditions as referred to in letter a) are not met, the importer must include:
- a photocopy of the GMP certificate issued by an accredited certification body recognized as equivalent to ASEAN Good Manufacturing Practice (GMP); and
- a photocopy of the Cosmetics industry/production permit.
What are the GMP Certificate requirements for the Cosmetics Industry located in ASEAN countries, but the Principal/Brand Owner is from outside ASEAN?
The GMP certificate issued by authorized government officials or recognized institutions in the country of origin; may also use a Self Declaration or GMP Statement made by the Factory/Cosmetics Industry (no need to be legalized by the Indonesian Embassy).
What GMP certificates are recognized as equivalent to ASEAN Good Manufacturing Practice (GMP)?
GMP certificates that are recognized as equivalent to ASEAN Good Manufacturing Practice (GMP) can be in the form of:
- International Standard ISO 22716
- Certificates that refer to Guidelines, including:
- a. WHO Guide to GMP for Pharmaceutical Products
- b. PIC/S Guide to GMP for Medicinal Products/Australian Code of GMP for Therapeutic Goods
- c. US CTFA Guideline for Cosmetic Good Manufacturing Practice
- d. COLIPA Guideline for Manufacturing of Cosmetic Products
Does the ISO 22716 certificate for producers outside ASEAN have to be legalized by the local Indonesian Embassy?
Yes. Based on the Regulation of the Head of the Food and Drug Supervisory Agency:
- Regulation of the Head of the Food and Drug Supervisory Agency No. 26 of 2018 concerning Electronic Business Licensing Services in the Drug and Food Sector in Article 13 point 4e.
- Regulation of the Head of the Food and Drug Supervisory Agency No. 14 of 2017 concerning Guidelines for Distribution Permits in Appendix 2.
Is it permissible for the ISO 22716 certificate to be issued by a certification body from a different country than the country of the factory?
Yes, it is permissible.
What if the authorized government official or recognized institution in the country of origin does not issue GMP?
The importer must include:
- A photocopy of the Cosmetics industry/production permit.
- A photocopy of the CPKB certificate issued by an accredited certification body recognized as equivalent to ASEAN Good Manufacturing Practice (GMP); and
What institutions can be accepted as issuers of ISO 22716 certificates?
Institutions that are accredited to issue ISO 22716, for example, SGS, Intertek, Bureau Veritas, Dekra Wit, Korea System Certification Body (KSCB), IQRA, Lloyd’s Register Quality Assurance Ltd, KIWA CERMET, TUV, Korea Management Registrar (KMR), AFNOR Asia Ltd, BSCIC Certifications Pvt. Ltd., Certiquality S.r.l. Instituto Di Certificazione Della Qualita, Advanced Certification Ltd, China Quality Certification Center (CQC), Institute of Global Certification (IGC), UL Register LLC, TB BELGELENDIRME, International Technology Standard (ITS), G-Certi, Euro-Quality System France, Pfeiffer Consulting, Global Standards Co., Ltd. (GSC), Quality Services Limited, Korean Foundation for Quality (KFQ), SQR Certification (Sigmacert), Perry Johnson Registrars, Inc.
What if the ISO 22716 certificate is issued by an institution that has not been previously known?
Supporting data must be included in the form of the institution’s company profile and proof of accreditation related to ISO 22716.
How long is the validity period of the Good Manufacturing Practice for Cosmetic (GMPC) Certificate that can be accepted in submitting a cosmetic notification business entity?
The remaining validity period is at least 6 (six) months before the certificate expires.
What things must be included in the GMP certificate?
The GMP certificate includes:
- The authorized party issuing the GMP
- Name and address of the factory
- Validity period
- Dosage form (if any)
- ISO guidelines used: ISO 22716, USFDA, ASEAN GMP
- Date, signature, and stamp of the Indonesian Embassy/Consulate General or KDEI Legalization (specifically for Taiwan)
What if the GMP certificate does not include a validity period?
The validity period of the GMP certificate is calculated as 5 years from the date of issue. Based on the Regulation of the Head of the Food and Drug Supervisory Agency:
- Regulation of the Head of the Food and Drug Supervisory Agency No. 14 of 2017 concerning Guidelines for Distribution Permits in Appendix 2.
- Regulation of the Head of the Food and Drug Supervisory Agency No. 26 of 2018 concerning Electronic Business Licensing Services in the Drug and Food Sector in Article 13 point 5.
If the product is produced in Korea, but the Principal is from the USA, is the GMP issued from the USA or Korea?
The GMP is issued by the country according to the location of the factory, namely Korea.
Can a foreign factory have GMP for Pharmaceutical/Drug products, can it be accepted as a GMP requirement?
It can be accepted if the dosage form is the same as the cosmetic dosage form to be imported.
