CGMP Compliant Facility Assessment for Cosmetics in Korea (우수화장품 제조 및 품질관리기준 적합업소)

Common situations

Pick the question closest to your case: each one gives the conclusion first, then what changes it, the documents involved and the expected timeline.

1. We are registered as a cosmetics manufacturer in Korea. Do we need a CGMP compliance decision to operate?

   Short answer No. CGMP is a standard that MFDS may recommend to manufacturers, and it is not a requirement for manufacturer registration. However, manufacturer obligations such as preparing and keeping standard documents and records, hygiene management and testing and inspection apply regardless of a compliance decision.

   • You only want to manufacture without a compliance decision Meet the manufacturer obligations (standard documents and records, facility hygiene and inspection, testing from receipt to release) and operate.
   • You want the compliant facility logo or adjusted surveillance Apply and operate the standard at least 3 times, then apply for the assessment.

   Documents

   Manufacturing control standard, product standard, manufacturing records, quality control records (obligations) / for a compliance decision, the application for assessment and attachments

   Timeline

   If you apply, the processing period on the application form is 90 days

2. Our factory is still being built. Can we apply for a cosmetics CGMP assessment before registering as a manufacturer in Korea?

   Short answer The standard is aimed at cosmetics manufacturers, and the application form asks for the plant's area, staff and operating record, so the order is to complete manufacturer registration first, apply and operate the standard at least 3 times, and then apply.

   • You are not yet registered as a manufacturer Complete cosmetics manufacturer registration first.
   • You are registered but lack an operating record Apply and operate the standard at least 3 times, prepare the self-assessment and then apply.

   Documents

   Cosmetics manufacturer registration documents (registration stage) / self-assessment, operating organisation, facility details, manufacturing control status, quality control status (assessment stage)

   Timeline

   Registration and operating time come first; after filing, the processing period on the form is 90 days

3. Our plant receives bulk product from elsewhere and only does filling and packaging. Can we still get a CGMP compliance decision in Korea?

   Short answer Yes. Partial processes are divided into bulk manufacturing and filling and packaging (primary packaging). You state the process on the application, and the certificate and logo are issued for partial processes.

   • You only do filling and packaging (primary packaging) Select filling and packaging under partial processes in the application category.
   • You do everything from bulk manufacturing to packaging Apply for all processes.

   Documents

   Application for assessment (with the application category stated), self-assessment, operating organisation, plant facility details, manufacturing control status, quality control status

   Timeline

   90 days under the application form

4. How many times must we operate the Korean cosmetics CGMP standard before submitting the self-assessment?

   Short answer The application must be accompanied by a self-assessment after applying and operating the Standards for Good Cosmetics Manufacturing and Quality Control at least 3 times.

   • You have operated the standard fewer than 3 times Complete the required number of runs before preparing the self-assessment.
   • You have records of 3 or more runs Prepare the self-assessment together with the other attachments and apply.

   Documents

   Self-assessment after applying and operating the standard at least 3 times, operating records

   Timeline

   In practice, time to complete the required runs is needed before filing

5. What level of floor plan and facility documents do we need for a cosmetics CGMP application in Korea?

   Short answer Submit a 1/100 scale measured floor plan showing the names of workrooms, testing room, storage and auxiliary facilities as well as doors and corridors, a ventilation system diagram, a water treatment system diagram, and lists of manufacturing and testing facilities and equipment (name, specification, quantity).

   • Your drawings are not measured floor plans Prepare a 1/100 scale measured floor plan again.
   • You outsource testing Include the contract testing agreement and management status in the quality control status together with the testing facility list.

   Documents

   1/100 scale measured floor plan, ventilation system diagram, water treatment system diagram, manufacturing facility and equipment list, testing facility and equipment list

   Timeline

   In practice, time to prepare drawings is needed

6. What goes into the manufacturing control status and quality control status for a Korean cosmetics CGMP application?

   Short answer Manufacturing control status covers the manufacturing control standard and list of rules, contract manufacturing agreements and management status, workroom zoning and entry rules, cleaning and disinfection, and pest control. Quality control status covers calibration management, manufacturing water control and test examples, equipment inspection rules and equipment register, and contract testing agreements.

   • You are a contract manufacturer Submit the contract manufacturing agreement and management status as well.
   • All testing is done in your own testing room Organise the management records for your own testing facilities without contract testing agreements.

   Documents

   Manufacturing control standard and list of rules, workroom zoning and entry rules, cleaning and disinfection records, pest control rules, calibration rules, manufacturing water control rules, equipment inspection rules and equipment register, contract agreements (if applicable)

   Timeline

   90 days under the application form (supplementation time additional)

7. How long does a cosmetics CGMP compliance decision take in Korea, from filing to certificate?

   Short answer The processing period on the application form is 90 days, following the order receipt → document review → on-site inspection → decision → notice and certificate.

   • A supplementation request is issued The process may take longer by the time needed to submit supplementary documents.
   • You are still preparing First estimate the time to apply and operate the standard at least 3 times.

   Documents

   Application for assessment of CGMP implementation and attachments

   Timeline

   90 days under the application form / operating and supplementation time are additional

8. To estimate the cost of Korean cosmetics CGMP certification, which preparation items should we check first?

   Short answer The items required by the standard are independent manufacturing and quality departments for each plant, standard documents and records, testing facilities and equipment with calibration management, manufacturing water control, and an operating record of at least 3 runs. The scope of preparation depends on which of these are already in place.

   • Facilities and standard documents are already in place Focus on operating records, the self-assessment and organising the attachments.
   • You outsource testing or calibration Arrange contract testing agreements and management records.

   Documents

   Operating organisation documents, plant facility details, manufacturing control status, quality control status, self-assessment

   Timeline

   In practice: preparing the standard → operating at least 3 times → filing; after filing, the processing period on the form is 90 days

9. Can we use the Korean CGMP compliant facility logo on cosmetics packaging and in advertising?

   Short answer A facility with a compliance decision may display the compliant facility logo on the plant and on cosmetics manufactured there, or advertise the decision. The logos for all processes and partial processes are different.

   • Your compliance decision covers only partial processes Use the partial-process logo.
   • The product was made at a facility without a compliance decision Do not display the logo or advertise compliant facility status.

   Documents

   Compliant facility certificate, logo design (scaled proportionally, printed or engraved)

   Timeline

   The logo can be displayed once the certificate is issued

10. If a follow-up inspection finds our facility non-compliant, will our Korean cosmetics CGMP decision be cancelled?

    Short answer MFDS inspects compliant facilities at least once every 3 years and may order a non-compliant facility to correct within a set period or cancel its compliant facility decision.

    • You receive a correction order Correct within the set period and submit the results.
    • Your manufacturing or quality control is considered problematic An ad hoc inspection may take place in addition to the regular one.

    Documents

    Correction results, standard documents and records, internal audit records

    Timeline

    Regular inspection at least once every 3 years / the correction period is set by MFDS

11. If an overseas manufacturer's quality control is recognised, can we skip domestic quality testing of imported cosmetics in Korea?

    Short answer A responsible seller importing cosmetics may skip domestic quality testing where the overseas manufacturer's quality control standard is mutually recognised between countries or recognised as equal to or higher than the Korean good manufacturing standard; the manufacturer's test report then replaces the quality control record.

    • You want to skip domestic quality testing Apply to the Minister of Food and Drug Safety for a site inspection of the overseas manufacturer.
    • The recognition is cancelled Domestic quality testing by batch is required again.

    Documents

    Site inspection application documents (under the procedure set by MFDS), the overseas manufacturer's quality test report, import management record

    Timeline

    The site inspection schedule depends on MFDS review

12. If we hire an administrative agent for a cosmetics CGMP application in Korea, what exactly do they handle?

    Short answer When authorised by the client, we review the application category, prepare the application for assessment, organise the attachment list and check for omissions, file with MFDS and respond to supplementation requests. We do not provide on-site quality consulting, design standard documents, carry out facility construction, or perform validation, calibration or testing, and the compliance decision is made by MFDS.

    • You have finished operating the standard and the self-assessment We organise the attachments according to the list, file them with the application and respond to supplementation requests.
    • You first need manufacturer registration Cosmetics manufacturer registration is handled first.

    Documents

    Letter of authorisation, application for assessment, self-assessment, operating organisation, plant facility details, manufacturing control status, quality control status

    Timeline

    90 days under the application form (supplementation time additional)

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