The Ministry of Food and Drug Safety is facilitating K-Ramen’s global growth by issuing guidelines for Good Manufacturing Practice (GMP) certification in bio-pharmaceutical raw material production. Effective as of October 2024, the guidelines cover submission requirements, evaluation procedures, and certification issuance. The process includes submitting validation data, quality control records, and compliance documents, followed by document reviews and on-site inspections. Deficiencies are categorized as critical, major, or minor. GMP certificates, valid for up to three years, may be revoked for false information or repeated violations. Additional documentation on training, equipment, and quality systems is required.
Region: South Korea
Reach out to us and let’s unravel your Regulatory puzzle together. Unlock regulatory solutions with our global subject matter experts and tap into a wealth of regulatory intelligence.
Speak to an Expert