Hanmi Fine Chemical.Co.,Ltd.

Quality Policy Quality Control GMP Approval

Quality Policy

Hanmi Fine Chemical complies with all global GMP requirements and operates the following quality policies.

We manage to produce and supply competitive, high-quality products that continuously satisfy the needs of our customers.
We establish, operate, and continuously enhance a quality management system that conforms to global GMP regulations.
We produce products of a consistent quality with secured safety and strive for continuous quality improvement.
We make efforts to share quality-related information between teams and to discover and solve mutual problems based on them.
We induce continuous quality improvement by implementing a quality monitoring system, evaluating the results, and reflecting such results to be practiced on-site.
To achieve the above goals, we provide support and put forth efforts to facilitate the acquisition of the necessary knowledge and skills through raising awareness, increasing motivation, and conducting continuous and repetitive education and training.

Act

Management Review
CAPA
Supplier Ratings
Customer Communication

Plan

Contract Review
Purchasing Requirements
Resource Requirements
Customer and Regulatory Requirements
Training Requirements

Do

Top Level Procedures
Department Work Instructions
Production Instructions
Training
Vendors / Suppliers
Maintenance

Check

Self Inspection
Process Measurements
Quality Goals Measurements
Quality Control

Quality Control

Quality Improvement
Enterprise Service Program
We are continuously enhancing quality reliability through Data Integrity so that confidence in our quality can lead to customer satisfaction.
Quality Culture
Human Resource Development
In order to provide high-quality products to our customers, we take the lead in fostering talents through various training programs and allow our technology to be accumulated so that it can further lead to specialization.
Customer Satisfaction
Business Partnership
In order to achieve the best service required by our customers, we are conducting quality activities in partnership with a specialized analysis equipment company to maintain the best laboratory condition through the periodic Analytical Instrument Qualification (AIQ) process and Preventive Maintenance (PM) activities.

Service Overview: Our personnel possess high levels of knowledge and vast experience, and they utilize global testing facilities to provide services through inspections to ensure compliance with clients’ standards.
In addition to the introduced equipment, we have diverse types of analysis equipment, and they are used for customer service.
Please ask us about any requests for analysis.

ICP-MS
XRD
Q-TOF/MS
NMR
PSD
LC/GC

ICP-MS: Inductively Coupled Plasma Mass Spectrometer

Used to measure the concentration of small metals and some non-metallic elements.

Manufacture

Agilent

Model No.

7700

XRD: X-Ray Diffraction

Used to reveal the atomic and molecular structure of the crystal by using the diffraction of X-rays entering the crystal.

Manufacture

Bruker

Model No.

D2 PHASER

Q-TOF LC/MS: Quadrupole Time of Flight LC/MS

The Q-TOF system features high sensitivity for ultra-trace compounds, and it can identify unknown substances using high level of precision, and additional information can be simultaneously identified through non-targeted analysis.

Manufacture

Agilent

Model No.

6550

NMR: Nuclear Magnetic Resonance Spectrometer

Used to analyze various organic compounds and confirm the synthesis of compounds through the RF (Radio Frequency) resonance for the rotation of the atomic nucleus of the sample to be analyzed.

Manufacture

GEOL

Model No.

400 MHz

PSD: Particle-Size Distribution

Used to measure the particle size and distribution of various materials using laser diffraction technology.

Manufacture

Malvern

Model No.

Mastersizer 3000

LC/GC: Liquid/Gas chromatography

Used for the analysis of various substances through diverse types of detectors, such as UV, MS, RI, CAD, DAD, FLD, FID, and TCD.

Manufacture

Agilent

Model No.

HPLC 1260 Infinity
UPLC 1290 Infinity Ⅱ
GC 7890

GMP Approval

Hanmi Fine Chemical has obtained GMP approval for its API manufacturing facilities from global regulatory authorities including those in the United States and Europe.