Product Safety & Quality
Product quality strategy
HK inno.N operates an Enterprise Quality Management System from the R&D stage of drugs to the point where they are administered to the patient, to ensure that safe drugs are manufactured and sold. As such, activities are carried out for systematic quality control, quality assurance and quality improvement so that only drugs whose safety, stability and efficacy have been proven are produced. The quality center at each plant, in charge of quality operations at HK inno.N, establishes quality-related policies, conducts its own quality audits and offers technological support for quality improvements to maintain and operate the Enterprise Quality Management System.
Meanwhile, a Quality Issue Response System and product test has been set up to promptly and flexibly cope with food-related issues and risks. Information is collected from a variety of sources to detect early on factors that could be problematic and take measures accordingly.
For matters requiring company-wide addressing, a meeting is summoned for a crisis management communication session and the matters are efficiently and promptly dealt with.
Information security strategy
Under the Chief Personal Information Officer, or CPO, HK inno.N has set up the Information Security Management System that operates the Information Security Committee where key employees take part in activities to safeguard the company’s major assets and the personal data of customers and employees from a variety of cyber threats and hacking incidents.
Sales·Marketing strategy
To comply with the Code of Ethics based on national laws such as the Pharmaceutical Affairs Act, the Labeling and Advertising Act, the Food Sanitation Act, and the Consumer Protection Act, the sales and marketing organization complies with these six principles following:
- Providing useful and valuable information to consumers
- Providing practical and valuable information to consumers
- Labeling the characteristics and efficacy of products in a truthful manner; Prohibition of false or misleading advertisements; Labeling of important information
- The effects of the product must undergo an interval verification process based on scientific methods.
- Content produced by an external body, too, must be thoroughly vetted.
- Any comparison with competitors must be done based on objective information.
- Laws regarding labeling and advertisements must be complied with
impacts
GMP certifications received
HK inno.N has received GMP certification from regulatory authorities both at home and abroad – a clear recognition of the high quality standards the company lives up to. The company conducts self-inspections and vendor audits to verify that GMP rules are complied with and to identify areas for corrective action. Inspectors are appointed based on their GMP-related knowledge and experience, to review in an objective manner the facilities, environment, workers’ practices, documents, validation, quality control, manufacturing procedure control, raw materials and product control and handling of complaints. Such inspections help the company take corrective and preventive actions against potential risk factors for ongoing improvement of its GMP system, so that ultimately GMP-compliant drugs can be manufactured and controlled properly.
| Drug manufacturing site | Korean certification | Relevant products | Valid period | International certifications |
|---|---|---|---|---|
| Osong | Compliant with GMP for the manufacturing and quality control of drugs |
1. OSDs : Non-sterile – regular products – OSDs (Powders, tablets, capsules) 2. Injections : Sterile-cytotoxic anti-cancer drugs – injections (injections) Sterile – regular products – injections (fluids) |
2028.03.10. Until 10th of March, 2028 |
Russia |
| Daeso | Compliant with GMP for the manufacturing and quality control of drugs |
1. APIs : Synthetic (non-sterile), Cephalosporin-based antibiotics (synthetic sterile) 2. Finished drug products : Fluids (Cephalosporin-based antibiotics (tablets), syrups (in solid form)) |
2028.05.03. 3rd of May, 2028 |
Japan, Vietnam, the Philippines, Uganda, Iran |
| Icheon | Compliant with GMP for the manufacturing and quality control of drugs; Compliant with GMP for the manufacturing and quality control of medical devices |
1. Finished drug products : Biological drugs (i.e. vaccines, genetically modified drugs) 2. APIs : Special drugs – Biological drugs (vaccines (cultured sterile), tablets (sterile), virus inactivation (sterile), concentrate manufacturing (sterile), biological drugs (genetically modified drugs (cultured sterile), tablets (sterile), virus inactivation (sterile), concentrate manufacturing (sterile))) |
2026.01.18. 18th of January, 2026 |
Thailand, Vietnam, the Philippines |
Quality inspections
To ensure that the company’s quality policy and quality-related laws are abided by, HK inno.N regularly monitors and evaluates how the Quality Management System at each manufacturing site is operated.
An annual quality program that takes into account the features of each site are established and implemented to continuously make improvements on quality, and monthly monitoring is used to check up on progress to ensure effective and efficient quality management.
Moreover, HK inno.N guarantees and checks for high quality for not only materials that the company manufactures in-house, but also the ingredients and materials used or produced by primary and secondary partner companies, as long as they are put into the production process at HK inno.N.
Product quality training for employee
To maintain high quality levels, for specific roles that require qualification or verification of capabilities, HK inno.N requires that individuals be verified for their capabilities before handling the tasks. In addition, systematic training programs, as well as opportunities t attend external training sessions and seminars are offered to employees. A program to foster experts in particular fields (i.e. Subject Matter Experts, or SMEs) and auditors also help to not only boost job-related knowledge but also to strengthen quality assurance of the company.
In addition, all employees of the manufacturing division are required to undergo annual GMP training and all employees are required to undergo drug safety training so that the overall quality levels at the company are kept high.
| Theme | Eligible employees | Subject | Number of employees who completed the training | Training hours |
|---|---|---|---|---|
| Production & Quality | Sum | 3,033 | 3,689 | |
| Employees handling directly relevant tasks | GMP training (Quality training) | 656 | 656 | |
| Data integrity | 656 | 1,312 | ||
| All employees | Drug integrity | 1,721 | 1,721 |
Product quality training for supply chain
HK inno.N periodically holds a meeting of the Partner Company Consultative Group on Quality once a year in the second half. All parter companies including dey suppliers and high-rish suppliers of HK inno.N are required to attend the meeting. HK inno.N shares the latest regulations and issues related to quality and provides quality training.
Information security monitoring
HK inno.N thoroughly tracks and manages all information collected from stakeholders in accordance with the company’s internal control system to mitigate risks associated with personal data and information security. Activities are carried out to identify in advance the security risks posed to information assets, and a system to protect information in real teal is operated.
Information security training
Additional training is conducted for employees who handle personal data along with information security training for all employees.
| Theme | Eligible employees | Subject | Number of employees who completed the training | Training hours |
|---|---|---|---|---|
| Information security | Sum | 1,778 | 1,812 | |
| Employees handling directly relevant tasks | Basic course on personal information security | 57 | 91 | |
| All employees | Training on personal information security | 1,721 | 1,721 |
Compliance monitoring
To ensure responsible sales and marketing, review of the sales and marketing activities is conducted by various departments. For materials promoting products, the academic team conducts a cross-check through a team of working-level employees and team leaders based on 「the Pharmaceutical Affairs Act」. Only cases that have been assigned a code are then produced and distributed. The same code is then used for post-distribution management.
Costs incurred by sales and marketing activities, too are entirely reviewed by the supporting division and the compliance division once a month. The supporting division checks for the effectiveness and efficiency of how resources were used, while the compliance division checks whether the funds were used in accordance with relevant laws and the company’s own rules. These reviews promote more responsible sales and marketing activities of HK inno.N.
Compliance training
HK inno.N conducts monthly regular training for the sales and marketing division. Regular training consists of training on the company’s products and their indications to improve the sales and marketing personnel’s expertise and ability to sell products based on scientific backing. This is done in parallel with compliance training to promote fair competition and compliance with rules. HK inno.N is providing compliance training about laws related to sales and marketing such as the Pharmaceutical Affairs Act, the Labeling and Advertising Act, and the Consumer Protection Act. There are also separate training sessions for new recruits and transferred employees to ensure that all employees are equipped with expertise and a compliance-focused mindset.
| Theme | Eligible employees | Subject | Number of employees who completed the training | Training hours |
|---|---|---|---|---|
| Sales&Marketing | Sum | 1,056 | 1,613 | |
| Employees handling directly relevant tasks | Products and their indications | 362 | 501 | |
| Compliance | 694 | 1,112 |