GMP Certification

GMP Definition

GMP stands for “Good Manufacturing Practice” and refers to the quality management system for medical device manufacturing. “Quality management system” refers to a management system to efficiently manage organization, responsibility, procedures, processes and resources for product quality control throughout the entire medical device process. (Medical device manufacturing and quality control standards)

Audit procedure flow chart

GMP Audit System
(Manufacturing)

Submission of application for review -> Review by quality control review institution and competent regional office -> Issuance of certificate of conformity

-  The validity period of the certificate of conformity is 3 years, and regular renewal examination is required every 3 years.

-  After the GMP grace period for each grade, only products from companies that have received GMP compliance certification can be sold.

GMP Audit System
(import)

(Examination classification) Audit that foreign manufacturer must undergo

In principle, each imported medical device foreign manufacturing site (hereinafter referred to as “manufacturing site”) undergoes GMP inspection, which is divided into initial audit, periodical renewal audit (3 years), additional audit (product group), and change audit (location).

• List of required documents

  ·  Copy of business license

  ·  Quality manual

  ·  Device Master Record

  ·  Submit notification-designated data such as manufacturer information overview

• Review institution

  ·  Korea Construction and Living Environment Testing & Research Institute (KCL)

  ·  Korea Testing and Research Institute (KTC)

  ·  Korea Testing Laboratory (KTL)

  ·  Korea Testing & Research Institute (KTR)

• Foreign manufacturer GMP

  Foreign manufacturer audit system

  · Independent :  Review institution

  · Joint :  Each regional food and drug safety office + review institution

Summary of GMP audit system