HK inno.N

Enterprise Quality Management System

Quality
Management

Policies to improve product quality are established and a quality management system is operated.
Quality
Assurance

The quality of drugs is guaranteed by meeting cGMP standards.
Quality
Improvement

Through technological support, inno.N aims not only to offer good products, but those that meet some of the most stringent quality standards.
Quality
Audits

Through continuous quality audits, one of the most thorough quality management systems is maintained and managed.

About the quality system

inno.N operates an Enterprise Quality Management System to ensure the safety of the pharmaceutical products, from their R&D stage to the moment they are administered to patients. Continuous quality management, quality assurance and quality improvement activities are carried out to produce drugs that meet the standards of cGMP for safety, stability and efficacy.

The quality teams on each site of inno.N establish quality policies, conduct quality audits throughout the entire site and offers technical support to maintain and manage the quality management system.

Quality Policy

OUR MISSION

Heal the World for a Better Life

Code of Conduct

We always listen to our customers and do our best to respond to their needs, fulfilling our social responsibilities for the patients suffering from disease and their families.
We constantly improve with the New Frontier spirit for better quality.
We follow principles and standards for quality and act honestly.
We strive to have the appropriate members and systems to improve quality.

Data Integrity

Establishing data governance and activities for improvement of data integrity

HK inno.N has established governance to ensure the quality and integrity of data related to pharmaceutical manufacturing, and actively promotes dissemination of the quality-first culture that prioritizes data integrity.
First, HK inno.N declares the policies and the Code of Ethics that reflect the philosophy of the Management on quality, and takes the lead in preventing data integrity issues by building systematic training programs and systems along with adequate allocation of resources.
Second, to form an open organizational culture, the Company promotes open communication and reporting on data integrity failures, errors of individuals/systems, or potential data integrity issues.
Third, systematic education and training are implemented to raise employees' awareness of data integrity, such as the importance of data integrity and its impact on quality.
Fourth, procedures and systems are established and in operation, enabling systematic management of data integrity, such as data risk assessment and management, data review, and periodic monitoring.
In particular, HK inno.N records/manages all GMP-related activities in accordance with the most up-to-date global GMP regulations to enhance the reliability of GMP data for pharmaceutical products of the Company.
Internally, the Company distributes DI Letters to employees for embedding the quality-first mindset, implements data integrity training and evaluations on a regular basis, and continues to promote various activities to raise awareness of data integrity.

IT Operating System for GMP

MES, Manufacturing Execution System
LIMS, Laboratory Information Management System
QMS, Quality Management System
EDMS, Electronic Document Management System

Strengthening Data Integrity

		Frequency	Year 2023	Year 2022	Year 2021
Education	Publication of DI Letter	Every month	10 times *	12 times	12 times
Education	DI training	Bi-annually	2 times, all employees at manufacturing department (631 employees)	2 times, all employees at manufacturing department (587 employees)	2 times, all employees at manufacturing department (546 employees)
Committee	DI Committee	Quarterly	4 times	5 times	3 times
Committee	Working-level Committee on DI	Quarterly	4 times	5 times	3 times
Audit	Self-audit on DI	Three times a year	3 times	3 times	3 times

* Published from February to November since year 2023

One of the most cutting-edge production facilities for pharmaceutical products in Korea that meets global standards, the Osong Plant is where high quality oral solid dosage products, Oncology Injectables and IV fluids are manufactured.

01

Compliance with cGMP/EU GMP
02

Cutting-edge manufacturing facilities and an IT system for the full production process
03

Production technologies and hands-on experience from over 30 years in the industry
04

Compliance with global standards for safety and environment

Address	239, Osong Saengmyeong 2 Ro, Osong-Eup, Heungdeok-Gu, Cheongju-Si, Chungcheongbuk-Do, Korea
Area of the site	146,013 m²
Area of the buildings	58,896 m²
Key facilities	12 buildings specializing each in the manufacturing of oral solid dosage products, Oncology Injectables and IV fluids
Dosage forms of products	Oral solid dosage products, Oncology Injectables and IV fluids
Certifications	KOSHA-MS, ISO 45001, ISO 14001, KGMP

Oral solid dosage products

Products can be manufactured to various scales using a closed system.

Oncology Injectables

A plant dedicated to the manufacturing of Oncology Injectables with cytotoxicity, it is equipped with a completely closed system to prevent contamination.

One of the largest smart factory in Korea with the latest automated facilities, the Osong IV Plant manufactures some of the highest quality IV products.

01

One of the largest production capacities in Korea with the latest automated facilities
02

A smart factory that operates based on Big Data analysis and forecasting
03

An environment-friendly production facility using renewable energy sources such as solar power
04

A global quality management system is implemented to ensure the highest quality in products

Address	239, Osong Saengmyeong 2 Ro, Osong-Eup, Heungdeok-Gu, Cheongju-Si, Chungcheongbuk-Do, Korea
Area of the site	146,013 m²
Area of the buildings	32,191 m²
Key facilities	Production lines in the IV building, automated warehouses and utilities
Dosage forms of products	Oral solid dosage products, Oncology Injectables and IV fluids
Certifications	KOSHA-MS, ISO 45001, ISO 14001, KGMP

IV fluids

The environment-friendly smart factory features one of Korea’s largest production capacities and the latest automated facilities to ensure global quality standards are met.

IV fluids, cephalosporin antibiotics (finished products, APIs), general APIs are manufactured and supplied to domestic and international customers.

01

A CMO of over 20 years with a major Japanese pharmaceutical firm
02

Specialized technologies for IV fluid production and automated facilities that meet GMP standards
03

Production facilities entirely dedicated to the API of K-CAB tablets, Tegoprazan
04

Over 20 years’ experience in manufacturing antibiotics of aseptic processing

Address	20 Daeso Sandan-Ro, Daeso-Myeon, Eumseong-Gun, Chungcheongbuk-Do, Korea
Area of the site	58,278m²
Area of the buildings	28,411m²
Key facilities	Twenty-five buildings including those dedicated for IV fluids, Tegoprazan, cephalosporin antibiotics, and TPN.
Dosage forms of products	IV fluids, oral solid dosage products, API for cephalosporin, General API
Certifications	KOSHA-MS, ISO45001, KGMP, PMDA, Iran FDA

Tegoprazan

A building is entirely dedicated to the production of the API of K-CAB tablets, Tegoprazan.

IV fluids

The building features the latest automated facilities that meet GMP standards and a conveyer system.

Antibiotics
(Cephalosporin)

Contract manufacturing antibiotic API and supplying to Japanese originators

Antibiotics
(Cephalosporin API)

API for antibiotics of aseptic processing(cephalosporin) export to Japanese originators

With over 30 years of experience in manufacturing biopharmaceutical products, the Plant supplies its products to domestic and international customers.

01

Vaccine production facilities that are GMP-compliant
02

With over 20 products registered in a number of countries including Thailand
03

A quality management system to ensure the manufacturing of premium quality products
04

Production technologies and hands-on experience from over 30 years in the industry

Address	811 Deokpyeong-Ro, Majang-Myeon, Icheon-Si, Gyeonggi-Do, Korea
Area of the site	34,751 m²
Area of the buildings	14,492 m²
Key facilities	10 buildings including those specialized for the production of vaccines and Epokine, and for quality management
Dosage forms of products	Biological products (e.g. vaccines and genetic recombination drugs), antibiotic injections
Certifications	KOSHA-MS, KGMP, TFDA, NADFC, Philippines FDA

Injections

Biological products and finished pharmaceutical products that meet the latest GMP standards are manufactured.

Epokine

With over 30 years of experience in manufacturing drugs, the source ingredients for biological products are manufactured.

Vaccines

Vaccines that meet the latest GMP standards are manufactured.

With the establishment of a highly reliable GMP Cell Center, HK inno.N has been leading the industry in the development and manufacturing of Advanced Therapy Medicinal Products.

01

One of Korea’s largest automated production facilities with a closed system
02

Cell & Gene Therapy production facilities that are GMP-compliant
03

A top-notch quality management system to ensure high quality products are manufactured
04

Infrastructure for the development and optimization of CGT processes

Address	Building D, 947 Hanamdaero, Hanam-Si, Gyeonggi-Do, Korea
Area of the site	Approximately 1,508 m2 or 457 pyeong
Key facilities	Process development lab, Quality testing and analysis lab, Aseptic manufacturing room, Storage room
Product formats manufactured	Advanced Therapy Medicinal Products (for Cell & Gene Therapy)
Permission	Permission for Manufacturing Advanced Biological Products (2022.08) Permission for Management Business of Human Cells (2023.09)

Process development lab

By developing and optimizing CGT processes, HK inno.N continues to increase its productivity.

Quality testing and analysis lab

Quality tests are conducted in accordance with the standards and regulations applicable to Advanced Therapy Medicinal Products.

Aseptic manufacturing room

A closed system consisting of automated facilities of some of the largest scales in Korea, set in a aseptic environment allows for CGT products of the highest quality to be manufactured.

inno.N

Company Overview

inno.N's Production Site