K-Ramen’s Global Growth: GMP Certification Guidelines for Bio-Pharmaceutical Raw Materials

The Ministry of Food and Drug Safety (MFDS) is supporting K-Ramen’s international expansion with new Good Manufacturing Practice (GMP) certification guidelines for bio-pharmaceutical raw material production, effective October 2024. These guidelines outline the necessary steps for manufacturers seeking GMP certification to ensure their products meet global quality standards.

Key Aspects of the GMP Certification Process:
Submission Requirements:

Manufacturers must submit validation data, quality control records, and compliance documents to begin the certification process.
Evaluation Procedure:

Submitted documents will undergo a thorough review process by the MFDS.
On-site inspections will be conducted to ensure compliance with GMP standards.
Deficiency Categorization:

Any deficiencies identified during the review or inspection will be categorized as:
Critical
Major
Minor
Critical and major deficiencies may delay certification or result in corrective action.
Certification Issuance:

GMP certificates will be issued upon successful completion of the evaluation and inspection process.
The certificates are valid for up to three years.
Revocation of Certification:

GMP certificates may be revoked if manufacturers provide false information or repeatedly violate GMP standards.
Additional Documentation:

Additional documentation will be required for the assessment of training, equipment, and quality systems in the manufacturing process to ensure continuous compliance with GMP standards.
This initiative aligns with K-Ramen’s efforts to expand its bio-pharmaceutical raw material production globally while ensuring high standards of quality and safety.

Source: https://www.mfds.go.kr/brd/m_1060/view.do?seq=15524&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1

Region: South Korea