Review & Approval
The National Lot Release System
- Unlike chemical drugs, biologics such as vaccines are produced using organism-origin materials, so it is difficult to
maintain consistency and safety throughout the manufacturing processes. As a result, it is essential that quality control
be conducted in each lot of biologics. Thus, in Korea, national lot release system has been implemented to further
confirm the quality of each lot of product before it is marketed.
From June 8, 2012, in conjunction with the existing lot release testing of final drug products, our national lot release
system has been put into effect to review the summary protocol for production and quality control. The summary
protocol is the summarized document on manufacturing processes and test results of products, covering from raw
materials to final drug products. This system has become well-established over the three years that have passed since its
The MFDS has committed to the improvement of national quality control system for the biologics and established a
comprehensive lot release system. The major improvement focuses on classification of risk of each product based on risk
analysis, thus enabling the system to apply different test items for lot release in each products
Please press the button below to see the corresponding flow chart image.