Pharmaceutical Product Safety Assurance

Ⅰ. Governance

Decision-making Structure

Hanmi Pharmaceutical enhances product quality by consistently producing all pharmaceuticals it manufactures and manages. To maintain a high level of GMP (Good Manufacturing Practice), we establish and operate a GMP Committee at each production facility, capable of guiding and supervising tasks related to GMP operations. In necessary production facilities, a Quality Risk Management Committee is convened and operated for the overall management of quality risk.

Pharmaceutical Safety Assurance Management Committee

Roles of Dedicated Organizations

Training for Maintaining Professional Expertise in Pharmaceutical Safety Assurance

Hanmi Pharmaceutical consistently attends all manufacturing manager training required by regulatory authorities, thereby continuously maintaining its professionalism and qualifications for ensuring pharmaceutical safety.

II. Strategy_Identification of Risks and Opportunities

Based on the analysis results from experts (IROs), Hanmi Pharmaceutical identifies key risks and opportunities that could significantly impact stakeholders and sustainability related to pharmaceutical safety assurance, and continuously strives to develop effective response strategies based on this identification.

Ⅱ. Strategy_Risk and Opportunity Response Plan

Compliance with International-level Quality Management Standards (GMP)

5 Main Quality Policies for High Product Quality 

To supply pharmaceuticals with guaranteed efficacy, safety, and quality to the market, Hanmi Pharmaceutical establishes and maintains a quality management system that meets the requirements of cGMP, laws, regulatory bodies, and ISO standards throughout the entire drug manufacturing process. Furthermore, based on know-how gained through numerous audits and collaborations with domestic and international regulatory bodies and partners over many years, our quality management system is capable of meeting not only domestic (MFDS) but also Global standard Quality system (US FDA six system / EMA) requirements. Based on production and distribution technologies that satisfy global standards and a high-quality system, we are doing our utmost based on five virtues to grow into an even higher global pharmaceutical company. 

 Hanmi Pharmaceutical Quality System

Under the management goal of providing safe and reliable medicines to consumers, all finished pharmaceutical products developed, produced, stored, and manufactured at Hanmi Pharmaceutical are managed within a quality system from the stage of pharmaceutical development, including the receipt of related raw materials, testing, dispatch, manufacture of semi-finished/finished products, In Process Control (IPC), product testing, labeling and packaging, storage, shipment, and distribution. Even after distribution, continuous monitoring is conducted from the perspective of safety and efficacy, thereby strictly and thoroughly managing the entire life cycle of distributed pharmaceuticals. 

Performance and Development Plan of the Quality Management System 

Hanmi Pharmaceutical's quality management system encompasses all elements of the quality system and management responsibilities, demanding the achievement, maintenance, and continuous improvement of pharmaceutical efficacy, safety, and quality control levels. Accordingly, Hanmi Pharmaceutical establishes quality objectives based on business goals, and the performance is regularly reported to management through committees. To continuously supply high-quality pharmaceuticals, management reviews and supports the necessity of facility investment, employee recruitment, software improvements, and the introduction of computerized systems, thereby striving to maintain the production and supply of high-quality pharmaceuticals. To more thoroughly ensure the efficient operation of the quality system and the Data Integrity of data generated throughout pharmaceutical development, manufacturing, and quality control, computerized systems such as ERP (Enterprise Resource Planning), EDMS (Electronic document management system), MES (Manufacturing Execution system), and LIMS (Laboratory Information Management System) have been introduced and are in use across various areas. Furthermore, by assigning Data Integrity specialists to each department, we ensure the integrity of data generated throughout pharmaceutical manufacturing, track related issues, and take timely actions on matters requiring improvement. Our company conducts regular risk assessments for each GMP department to continuously strengthen the level of data integrity, and based on these assessments, we are continuously evolving our quality management system. 

Regulatory Authority and Partner Audit History

To date, Hanmi Pharmaceutical has certified the effectiveness and suitability of its operational quality management system through inspections by regulatory bodies such as MFDS (Korea), US FDA (United States), EMA (Europe), PMDA (Japan), and MITRF (Russia). By regularly undergoing audits from partners in various countries, we assure them that a reliable GMP system is in operation. In 2025, we underwent a total of 10 inspections from domestic and international regulatory/certification bodies and partners, including the US FDA and Korea's Ministry of Food and Drug Safety (MFDS), through which we confirmed that our manufacturing facilities and quality system are robustly maintained.

History of Major Regulatory Agency Inspections Over the Last 5 Years 

2025 Partner Audits Received Status

Systematic Quality Assurance System

Establishment of Risk-based Quality Assurance System

Hanmi Pharmaceutical operates a quality assurance system by applying risk management procedures to all processes in the GMP area that require a risk management approach throughout the entire product lifecycle. By making effective and consistent decisions based on risk assessment results related to pharmaceutical quality, we prevent foreseeable risks and implement measures to minimize the extent of risks that must be accepted. 

Education and Training

Hanmi Pharmaceutical manages GMP training through its electronic learning management system, LMS (Learning Management System). All employees working at business sites are assigned duties only after completing training appropriate for their respective roles, including on-the-job training. Regular basic GMP-related training is conducted to ensure that employees are adequately aware of the key concepts of the quality system and the importance of pharmaceutical quality control. Additionally, employees are supported to complete external training operated by pharmaceutical-related institutions, universities, the Ministry of Food and Drug Safety (MFDS), and overseas regulatory agencies based on their required topics, in addition to internal training. When necessary, secondary training is appropriately conducted by providing cascade training to required personnel.

Inspections for Pharmaceutical Safety

Hanmi Pharmaceutical voluntarily inspects the entire process and results of product manufacturing and quality control, as well as the integrity of all data generated during these processes, through its Quality Assurance department. We strive to improve any deficiencies ourselves to supply excellent pharmaceuticals to patients.

Genotoxic Impurity Management

Hanmi Pharmaceutical has established and operates procedures that enable quick and immediate responses upon the issuance of safety information and official directives regarding genotoxic impurities from overseas authorities and the MFDS. We identify affected products based on safety information, verify all batches currently on the market, establish analytical methods capable of detecting these impurities, and determine the impurity levels within distributed batches as quickly as possible. For previously produced batches exceeding the specified limits, sales suspension and recall measures are taken in accordance with MFDS review results. For future production batches, various methods to reduce the genotoxic impurities are reviewed, and quality tests for these impurities are performed upon batch release, thereby striving to ensure that only safe pharmaceuticals are supplied to patients.

Advanced Quality Control System

Hanmi Pharmaceutical's Quality Control Group collects samples of raw materials, intermediates, and final products used in pharmaceutical manufacturing, conducts product characteristic analyses required by authorities, and performs evaluations across all development stages, including release testing and stability testing for pharmaceuticals manufactured according to verified analytical methods and approved specifications, to ensure the safety, stability, and overall quality of manufactured and distributed raw materials/finished pharmaceuticals.

Quality Control Testing

Hanmi Pharmaceutical ensures that the quality of all distributed pharmaceuticals is maintained throughout their product lifecycle by performing raw material testing, in-process controls (IPC), drug product release testing, and stability testing related to the pharmaceuticals manufactured. Furthermore, in accordance with ICH Q2(R1) guidelines, method development and method transfer for developed methods are possible, and method verification as required by domestic and international regulatory agencies is also performed. A system is established to manage the release and distribution of only finished pharmaceutical products whose quality has been confirmed to meet standards through release testing, and employees performing quality control duties are regularly qualified through job-specific training and evaluations.

Stability program

Hanmi Pharmaceutical guarantees that the quality of pharmaceuticals manufactured by the company remains stable throughout the product lifecycle. Generally, stability rooms/chambers for long-term and accelerated conditions are operated according to product storage conditions, and facilities capable of performing stability tests under other special requirements are prepared to collect physical/mechanical stability data for pharmaceuticals. The stability data collected is monitored in real-time, and in the event of significant changes or non-conformities in drug quality, immediate impact assessments and reports to regulatory authorities are made according to relevant procedures to ensure necessary measures are taken.

Environmental and clean utility monitoring

Hanmi Pharmaceutical designs and manages all areas where pharmaceuticals are manufactured, packaged, and stored to be suitable for operation, maintenance, and cleaning. Walls are managed with clean panels for easy cleaning and maintenance, and floor surfaces are epoxy-coated to prevent contamination in the manufacturing environment and facilitate cleaning. Furthermore, environmental monitoring is conducted by categorizing cleanliness levels for each area, and process water, water for injection, and compressed air used in manufacturing are periodically sampled and subjected to quality tests. During environmental monitoring, tests are performed for airborne viable particles (settle plates), airborne non-viable particles (active air sampling), surface microbial counts, and particulate matter for each cleanliness grade. For water monitoring, tests for appearance, total organic carbon, conductivity, nitrate, pH, and endotoxin are conducted. All air compressors are oil-free type and supplied after passing through a 0.2μm filter.

Monitoring system within the lifecycle of shipped pharmaceuticals

Drug theft and counterfeiting monitoring system

Hanmi Pharmaceutical has established and operates a system for preventing counterfeit drugs and ensuring safety management from the manufacturing to the final distribution stage of finished pharmaceuticals, utilizing an ERP (Enterprise Resource Planning) system and unique identification devices like RFID (Radio-Frequency Identification) Tags. When a headquarters sales representative inputs order information received from a client company into the ERP system, this information is automatically transmitted to the delivery team via the system, and subsequently, shipment information for the ordered products can be confirmed in real-time through the system. All finished pharmaceuticals manufactured and shipped by Hanmi Pharmaceutical support the use of serialization and tracking technologies using RFID Tags, thereby strengthening supply chain security and establishing and managing a system compliant with distribution management policies in relevant export countries, including South Korea. Detailed information (manufacturing date, batch number, shipment date, customer information, etc.) for all finished pharmaceuticals dispatched and distributed is recorded in the internal system, enabling tracing and prompt action in the event of a report regarding counterfeit drugs. Furthermore, upon receipt of a consumer complaint, a swift investigation is conducted according to internal quality assurance procedures to assess the potential impact of the complaint on product quality, after which improvement measures are formulated to ensure appropriate actions are taken in a timely manner.

Pharmacovigilance system

Pharmacovigilance refers to the scientific activities concerning the detection, assessment, understanding, and prevention of adverse drug reactions or safety-related problems of pharmaceuticals. Pharmacovigilance is an activity conducted throughout the entire lifecycle of a drug, from the collection of drug safety information to risk management. In Korea, continuous supplementation and development of the pharmacovigilance system are being made by introducing and strengthening policies such as the drug re-evaluation system, the voluntary adverse event reporting system, the risk management plan system, recommendations for appropriate drug use, and the drug adverse reaction relief system. Hanmi Pharmaceutical, aiming to contribute to enhancing drug safety, has established and operates its own pharmacovigilance system, collecting and analyzing safety information for its own pharmaceutical products through various channels.

Pharmacovigilance training

Hanmi Pharmaceutical conducts its own regular pharmacovigilance training for all employees annually. This training emphasizes the necessity and importance of pharmacovigilance while providing guidelines for all employees to timely report information about adverse events they may encounter in their work to the pharmacovigilance department. This strengthens the company-wide pharmacovigilance system and contributes to improving Hanmi Pharmaceutical's drug safety management.

Customer health and safety

As all products manufactured by Hanmi Pharmaceutical are directly linked to health and life, we continuously strengthen and monitor our capabilities to ensure product safety. Hanmi Pharmaceutical transparently discloses publicly available product information to ensure that customers can safely take all its products, and considers customer safety and health aspects from the product development stage. Furthermore, customer feedback related to products is collected and managed in accordance with the regulations of the Ministry of Food and Drug Safety (MFDS).

Status of Administrative Dispositions in 2025

Group Integrated Call Center

Hanmi Pharmaceutical established its Group Integrated Call Center in 2014 and has been dedicated to listening to customers' voices. By managing collected issues and based on frequently asked questions about product usage, the company is actively working to eliminate factors causing customer inconvenience. This initiative is part of Hanmi Pharmaceutical's commitment to customer satisfaction management, aiming to enhance customer convenience and reach out to customers.

Hanmi Pharmaceutical's Major Customer Feedback Received and Actions Taken in 2025

III. Risk Management

Hanmi Pharmaceutical effectively manages enterprise-wide risks and maximizes potential opportunities to foster sustainable growth by integrating its risk and opportunity management process, related to pharmaceutical safety assurance, with the Enterprise Risk Management (ERM) system.

Ⅳ. Indicators and Targets