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Hanmi Fine Chemical.Co.,Ltd.

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HomePlants & QualityQuality Control System

Plants & Quality

Quality Control System

Quality Control

Quality assurance is one of the core values of Hanmi Fine Chemical and a duty that must be fulfilled to gain and maintain customer trust. We have confidence in meeting the high standards we have set for ourselves as well as the level of quality demanded by our customers. In order to assure that our products satisfy our own standards as well as those of our customers, we have dedicated most resources including human resources to the divisions associated with quality control and management.

Quality Policy

Hanmi Fine Chemical establishes a quality policy and notify all the workers throughout our facilities thereof on a regular basis. The following matters are prescribed in our quality policy:

"We shall provide high quality products that meet the demands and expectations of our customers;
establish and operate a quality control system that conforms to the ISO and ICH Guidelines and GMP regulations;
perform regular quality review of APIs to substantiate the consistency of processes;
discover and resolve any quality-related issues through inter-departmental cooperation and effective communication among ourselves;
continually improve our product quality based on a quality observation system and evaluation of process application and results;
and provide continuous education and training to the workers and the necessary motivation. "

Quality Control System Factors

The quality control system of Hanmi Fine Chemical encompasses activities performed to assure the appropriateness of the organization structure, procedures, processes, resources and the quality and purity of the manufactured APIs.
All the activities related to quality control and assurance have been set forth as documented regulations and policies and are recorded immediately upon their execution. Deviations that violated the established regulations and policies have also been documented and explained, and in the event of a major violation, investigation is conducted and the content and results thereof are documented. We have established the necessary regulations and policies on handling customer complaints on quality, recall and regulatory control as well as on product defects, serious incompliance with GMP, and field inspections by external institutions. At Hanmi, we have quality divisions, operating independently from the Production Division, that are in charge of quality control and assurance activities. We also have designated individuals who are responsible for each semi-finished and finished product items, and restrict sales of products that are determined to be non-conforming by the Quality Control Division.

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