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
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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)”
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Design – the First step
Engineering Code Check
Regulations review
Licensing
Basic Layout
Site Survey
Raw data Check
Risk Consideration
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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
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Design – the Third step
Execution Drawings
Specifications
DQ (Design Qualification)
