• GREETING OF CEO
  • OVERVIEW
  • ORGANIZATION
  1. GMP
  2. CGMP
  3. HACCP

The manufacturing of pharmaceuticals shall comply with the Good
Manufacturing Practice for pharmaceutical products in Korea (KGMP) pursuant
to Article 22 on enforcement regulations of Pharmaceutical Affairs Act

  • KGMP
    (Korea Good Manufacturing Practice)

    Manufacturing and quality control standards of
    pharmaceuticals in Korea

  • cGMP
    (current Good Manufacturing Practice)

    Pharmaceutical production management standards applied
    in the USA

  • EU-GMP
    (European Union Good Manufacturing Practice)

    Pharmaceutical production management
    standards applied in the EU

Pharmaceuticals, as products for human health, shall comply with various regulations for securing quality such as efficacy, safety and stability from manufacturing to sale
(Pharmaceuticals shall be safe without side effects and stable so as to have the same effect. Moreover, they shall have similar effect on most patients)

It is duty in Pharmaceutical Affairs Act to establish, execute, and maintain quality & production management system of pharmaceuticals, through systematic management of production process from raw material purchases to manufacturing, packaging and shipping.

KGMP (Korea Good Manufacturing Practice) is the essential requirement in manufacturing and sales of pharmaceuticals. Because, in May 1992, structures and facilities of KGMP were prescribed in “Facility Standard Decree of manufacturer, importer and distributer of pharmacy and pharmaceutical (Presidential Decree No. 13637)”, and organizational management was prescribed in “Korea Good Manufacturing Practice (The Ministry of Health-Welfare Announcement No.1992-44)”

  • Design – the First step

    Engineering Code Check


    Regulations review


    Licensing


    Basic Layout


    Site Survey


    Raw data Check


    Risk Consideration

  • Design – the Second step

    Basic Engineering


    Layout Confirmation


    Defining purpose each space


    HYAC Load calculation


    Total system P&ID


    Estimated Construction Costs


    Licensing


    Risk Analysis

  • Design – the Third step

    Execution Drawings


    Specifications


    DQ (Design Qualification)