Environmental
Social
Governance
ESG
Customer-Oriented
Quality Management
In the CDMO business, which underpins pharmaceutical quality, thorough quality control is a core element for maintaining partnerships with clients. If a manufacturing quality issue or data integrity violation occurs, it can lead to serious regulatory and financial risks such as license revocation, product recall, and compensation for damages. Accordingly, ST Pharm operates a dedicated Data Integrity Compliance (DIC) organization and has introduced cloud-based electronic systems to strengthen data reliability and management systems. We also maintain a quality management system that meets international standards by continuously passing global regulatory inspections and client audits. This systematic quality management strengthens trust with global clients and serves as a foundation for securing continuous business competitiveness.
Governance
| Category | Organization | Leadership | Composition | Roles & Responsibilities |
| Company-wide Oversight Committee | Social Responsibility Management Committee | CEO | Management |
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| Working-Level Committee | Manufacturing Quality Committee (GMP Committee) |
Manufacturing Quality Committee Chairperson (GMP Chairperson) |
Team Leaders of Quality Assurance, Quality Control, Production, Warehouse Operation, Facility Operation & Supporting and EHS |
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| Subcommittees | GMP Subcommittee | Head of Department Submitting the Agenda | Working-level organizations related to items on the agenda |
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| Implementing Organization | Quality Assurance Department |
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| Quality Control Department |
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| Production Team |
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| EHS Team |
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| Facility Operation & Supporting Team |
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| Warehouse Operation Team |
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Quality Management Policy
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Operating a quality system aligned with business goals based on our corporate motto (Service, Cooperation, Creativity)
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Including a commitment to meeting requirements and continuously improving the effectiveness of the quality management system
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Providing a framework for setting and reviewing quality objectives
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Maintaining continuous communication and implementation with employees at the Sihwa and Banwol Campuses
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Reviewing through internal quality audits and management review meetings (Company-wide Quality Management Committee) for continued suitability
Quality Management Objectives
- GMP compliance based on ICH Q7
- Continuous Quality Improvement through Quality Risk Management
Quality Management Goals
Quality Management System
As a company that primarily produces active pharmaceutical ingredients (API), ST Pharm operates a quality management system that complies with Good Manufacturing Practice (GMP) based on ICH Q7, the guideline of the International Council for Harmonisation (ICH). Through this, we maintain a global-level manufacturing and quality control system that reflects the requirements of clients in each country and the latest regulatory trends.
Quality Risk Management
Supplier On-site Audit
To secure product quality and safety from the raw material stage, ST Pharm operates a raw material management system that meets global regulatory standards. Due to the nature of the pharmaceutical industry, the quality of materials provided by suppliers-such as raw materials, sub-materials, and packaging materials—directly affects final product quality, making systematic supplier management a key element. Accordingly, we assign a management grade based on the importance of each raw material according to our internally established supplier management SOP, and in particular conduct regular on-site audits of Class A suppliers, which are of high importance.Safe Raw Material Management
ST Pharm has built a management system through the Inventory Management System (IMS) that allows real-time confirmation of raw material location, test status, inventory status, and inbound/outbound history, thereby enhancing the transparency and efficiency of raw material management. This system controls quality risks in advance and provides a foundation for quickly identifying the flow and status of raw materials and responding in a timely manner. In addition, due to the nature of the CDMO business, the level of warehouse management acts as an important indicator of quality reliability in the client audit response process, and we strengthen our audit response capability through a systematic raw material management system.Data Integrity
ST Pharm continuously enhances the reliability and utilization of quality data through the digital advancement of its quality management system (QMS) and the strengthening of data integrity. We have operated a data integrity management system since 2012, and in 2023 newly established a dedicated organization, the Data Integrity Compliance (DIC) Team, to build an integrated management system that meets global regulatory standards. We introduced cloud-based electronic quality management systems such as a document management system and a training management system, and in 2024 completed the transition of major QMS items to a digital system aligned with global standards. In 2025, we built an Annual Product Quality Review (APQR) electronic system to systematize the process, and introduced a Quality Metrics and Analytics Platform (QMAP) based on data accumulated in the electronic quality management system (eQMS) to visualize and manage key quality indicators such as deviations and test investigations.Strengthening Quality Control Capabilities
ST Pharm operates a systematic training program for employees in charge of quality-related work to maintain the highest level of quality. According to the GMP training management SOP, we conduct training that includes the core principles of manufacturing and quality control and their practical application, thereby strengthening the capability to comply with quality standards and procedures. By conducting regular monthly training not only for new hires but also for existing employees so that they can respond to the latest regulatory trends and changes in quality standards, we continuously enhance company-wide quality expertise and regulatory response capabilities.Quality Training Status
| Category | Target | Content | Cycle |
| Onboarding training | New hires | An overview of company policies, safety, and GMP requirements and standards | Upon hiring |
| New hire job training | New hires | SOP, job overview | Before starting work after assignment |
| Job training | All employees | Team job responsibilities | Once a month (12 times a year) |
| Regular training | All employees | Key GMP requirements, repeated training by topic |
Strengthening Customer Satisfaction
Customer Communication Management
ST Pharm designates dedicated personnel for each business and product for close collaboration with clients, operating a prompt and systematic response system. Client communication is led by the Project Manager (PM), with QA operating in a structure that supports quality issue response.
Communication with clients takes place through regular and ad-hoc Technical Conferences (TC), and according to business characteristics, we conduct weekly TC meetings by agenda, including regular TCs, business meeting TCs, analysis TCs, and production TCs. In addition, when an issue arises, we immediately hold an ad-hoc TC to share the problem and consult on the response direction. Along with this, we secure transparency and strengthen mutual trust through various on-site visit activities such as client audit response, production observation, inventory inspection, technical workshops, EHS Engagement Visits, and Mock Pre-Approval Inspections (Mock PAI). Through the PM-centered client management system, we comply with the project-specific standards presented by clients, and when a quality issue arises, we establish a response strategy by comprehensively reviewing aspects including sales impact and opportunity cost.
Communication with clients takes place through regular and ad-hoc Technical Conferences (TC), and according to business characteristics, we conduct weekly TC meetings by agenda, including regular TCs, business meeting TCs, analysis TCs, and production TCs. In addition, when an issue arises, we immediately hold an ad-hoc TC to share the problem and consult on the response direction. Along with this, we secure transparency and strengthen mutual trust through various on-site visit activities such as client audit response, production observation, inventory inspection, technical workshops, EHS Engagement Visits, and Mock Pre-Approval Inspections (Mock PAI). Through the PM-centered client management system, we comply with the project-specific standards presented by clients, and when a quality issue arises, we establish a response strategy by comprehensively reviewing aspects including sales impact and opportunity cost.
Complaint and Recall Management
ST Pharm operates a response process based on its own handling of complaint SOP to handle client complaints quickly and systematically. When a complaint is received from a client or clinical-related institution, we complete registration within 1 day, and complete investigation and cause analysis within 1 month after receipt. According to investigation results, we conduct corrective and preventive action (CAPA) to prevent recurrence, with QA overseeing the investigation process and the PM handling client communication to transparently share progress.
In addition, if a recall is required for products manufactured and shipped by ST Pharm or for raw materials and materials supplied by suppliers, we operate a systematic process based on the recall control SOP. To verify the effectiveness of the actual recall procedure, we conduct mock recalls on a 1-year cycle, thereby guaranteeing complete product traceability. To date, no product recalls have occurred.
In addition, if a recall is required for products manufactured and shipped by ST Pharm or for raw materials and materials supplied by suppliers, we operate a systematic process based on the recall control SOP. To verify the effectiveness of the actual recall procedure, we conduct mock recalls on a 1-year cycle, thereby guaranteeing complete product traceability. To date, no product recalls have occurred.
Customer-Oriented Mindset Internalization Training
ST Pharm developed and operated a training course to internalize the importance of a customer-oriented mindset company-wide, in response to the changing management environment and intensifying competition in the CDMO market.
In particular, we defined the core values of customer-oriented behavior as proactive communication that preemptively understands and responds to client needs, flexibility that flexibly responds to the changing environment and client demands, and a sense of urgency that prioritizes core tasks and preemptively responds to potential delay factors, and established these as company-wide common behavioral standards.
This course was designed based on a 3-year Master Plan progressing from awareness to application to reinforcement, considering employees’ acceptance and learning effectiveness, and in 2025 we focused on the “awareness” stage, concentrating on understanding the concept of a customer-oriented mindset and enhancing awareness of its necessity. The training was conducted for all employees and composed as a participatory program combining lectures, discussions, and practice. The detailed modules consisted of M1: awareness of environmental and technological change and understanding of CDMO market change, and learning the concept of a customer-oriented mindset; M2: understanding Value Challenge and mission/game activities to respond quickly to client demands; and M3: sharing customer-oriented practice cases and deriving behavioral commitments. The overall training satisfaction was 93%, and through pre/post comparison, it was confirmed that understanding of and empathy for the customer-oriented mindset improved significantly. We plan to continuously advance practical capabilities in the field through “application” and “reinforcement” stage training going forward.
In particular, we defined the core values of customer-oriented behavior as proactive communication that preemptively understands and responds to client needs, flexibility that flexibly responds to the changing environment and client demands, and a sense of urgency that prioritizes core tasks and preemptively responds to potential delay factors, and established these as company-wide common behavioral standards.
This course was designed based on a 3-year Master Plan progressing from awareness to application to reinforcement, considering employees’ acceptance and learning effectiveness, and in 2025 we focused on the “awareness” stage, concentrating on understanding the concept of a customer-oriented mindset and enhancing awareness of its necessity. The training was conducted for all employees and composed as a participatory program combining lectures, discussions, and practice. The detailed modules consisted of M1: awareness of environmental and technological change and understanding of CDMO market change, and learning the concept of a customer-oriented mindset; M2: understanding Value Challenge and mission/game activities to respond quickly to client demands; and M3: sharing customer-oriented practice cases and deriving behavioral commitments. The overall training satisfaction was 93%, and through pre/post comparison, it was confirmed that understanding of and empathy for the customer-oriented mindset improved significantly. We plan to continuously advance practical capabilities in the field through “application” and “reinforcement” stage training going forward.