We are committed to fulfilling
our social responsibilities

to customers, employees,
and local communities.

Responsibility to Quality

Customer Safety and Product Quality

Our commitment to safeguarding the health and well-being of all stakeholders, from customers to patients, drives us to uphold the highest standards of quality and safety. We actively engage in risk prevention and maintain a sustainable, reliable supply chain.

Quality BY VISION

  • MISSION

    Customer satisfaction
    through excellent product quality

  • VISION

    Leading the health industry by
    continuous quality culture improvement

  • CORE VALUE

    • Quality
      Leadership

    • Patient
      Prioritization

    • Continual
      Improvement

    • Sufficient
      Resources

    • Quality based
      Communication

Quality Management Strategy

GC Biopharma issued Corporate Quality Manual (CQM) that defines consistent and standardized quality levels in an effort to quality system ensures the quality, efficacy, and safety of all products and services while meeting domestic and international regulatory requirements.

GC Biopharma Quality Management System
(CQP, Corporate Quality Policy)

GC Biopharma Quality

  • Quality
    System

    • Change Management
    • Risk Management
    • Deviation Management
    • Document Management
    • Training Management
    • Data Trending Management

  • Regulatory
    Management

    • Market Authrozation
    • Audit Management
    • Data Integrity Management

  • Raw Material Management

    • Supplier Management
    • Raw Material Management

  • Facility &
    Equipment
    Management

    • Facility Management
    • Equipment Management
    • Utilities Management
    • Qualification Management
    • Computer System Management

  • Manufacturing
    Management

    • Manufacturing Management
    • Contamination Management
    • Validation Management
    • Intermediate Product Management
    • Contract Operations Manufacturing

  • Laboratory Management

    • Laboratory Supply Management
    • Sample Management
    • Analytical Process Management
    • Out-of-Specification Management

  • Packaging &
    Distribution Management

    • Product Release Management
    • Returned Products Management
    • Recall
      Management
    • Complaint
      Management
    • Management of non-complying product

Health & Safety Management

We prioritize the safety and health of all stakeholders.

We are committed to creating a workplace where employees feel safe, stay healthy, and thrive. To support this goal, we have implemented a comprehensive health and safety management system in accordance with international standards ISO 45001 standards (Occupational Health and Safety Management Systems). Additionally, we apply Process Safety Management (PSM) to enhance operational safety. Our commitment to Environmental, Health, and Safety (EHS) is formalized through a policy that clearly defines our goals and responsibilities.

Health & Safety Leadership Structure

Our dedicated health and safety team leads company-wide safety initiatives.
The SHE (Safety, Health, Environment) Committee meets regularly to evaluate performance,
strategize improvements, and address key safety issues.

  • CEO

  • Board of Directors

    • Corporate decision-making body (CEO, management officers)
    • Held annually

    SHE Committee

    • Held three times a year

  • Chief Safety and Environmental Officer (CSEO)*

  • SHE Team (Dedicated Unit)

  • Health & Safety Manager (Overall Responsibility)

  • Occupational Safety & Health Committee

    • Held quarterly

    Supplier Council Meetings

    • Held monthly

  • Health & Safety Managers

  • Supervisors
    Workshop

    • Held twice a year

  • Supervisors/Field Workers

* Chief Safety Environment Officer

Health & Safety Management Policy Goals

  • 2022 ~ 2023

    Stage 1:

    Foundation
    Phase

    Stage 2:

    Implementation
    Phase

    Establishment of documentation
    and supervisory response systems

  • 2024 ~ 2027

    Stage 3:

    Application
    Phase

    Stage 4:

    Development
    Phase

    Building a self-regulating
    preventive system

  • 2028 ~ 2030

    Stage 5:

    Maturation
    Phase

    Stage 6:

    Optimization
    Phase

    Embedding a safety culture

  • Strengthening internal audits (from annual to biannual)
  • Enhancing compliance assessments with safety and health-related laws
  • Measuring company-wide safety culture and establishing long-term strategic directions
  • Expanding employee health management programs (such as smoking cessation and alcohol reduction)
  • Expanding the training of emergency response personnel (CPR) (including employees in sales, warehouses, and headquarters)

Health & Safety Management System

We implement the ISO 45001 Occupational Health & Safety Management System to comply with both domestic and international health and safety regulations and meet customer expectations. This comprehensive system addresses safety and health across all products, activities, and services, supporting our commitment to sustainable development.

ISO 45001 Certificate Health & Safety Management System

Human Rights Commitment

We are dedicated to upholding human rights in our business practices.

At GC Biopharma, we are dedicated to upholding human rights in every aspect of our business to prevent any potential risks of violations. We've put in place a robust human rights management system that aligns with international standards, promotes open communication, and ensures clear procedures for addressing concerns.

Human Rights Policy

Our human rights policy guarantees respect for
and protection of the rights of our employees and stakeholders.
This commitment extends beyond our direct workforce
to include our global subsidiaries, affiliates, and business partners,
ensuring that all those connected to our operations are treated with dignity and fairness.

  • 01Core Human Rights
    Principles

    We believe strive to in fostering a work environment that respects the rights of everyone involved in our business operations. Guided by international frameworks, including the UN Universal Declaration of Human Rights, the UN Guiding Principles on Business and Human Rights, and the International Labour Organization's conventions, we have created a "Human Rights Charter" to reinforce our commitment. Additionally, we have implemented ethical standards and codes of conduct for our employees and partners to ensure that human rights are upheld at every level of our operations.

  • 02Human Rights
    Training

    At GC Biopharma, we recognize the importance of human rights management. To promote awareness and respect for human rights, we conduct annual training for all employees. This training covers key areas such as preventing sexual harassment, addressing workplace bullying, and improving disability awareness, with a specific focus on labor rights for all employees in South Korea.

  • 03Scope of the
    Human Rights Charter

    Our Human Rights Charter applies across all areas of our business operations, covering employees at all levels—including executives, staff, and non-regular workers—as well as business partners, suppliers, and stakeholders involved in investments, mergers, and acquisitions.

Grievance Handling System

We are committed to addressing employee concerns, including human rights issues, through secure and anonymous grievance channels. Our primary grievance forum, the Counseling Cafe, allows employees to submit concerns confidentially, and we ensure a swift response. For complex issues requiring more time, we provide a clear action plan with defined timelines.

Human Rights Grievance Escalation Procedures

  • Submission

    Employees submit grievances,
    including human rights concerns,
    via the Counseling Cafe.

  • Review and Assessment

    We verify the details of the submission,
    ensure whistleblower protection,
    and assess possible actions.

  • Communication of Results

    The review results are shared with the employee,
    along with any necessary consultations.

  • Resolution

    Depending on the case,
    disciplinary actions and preventive training
    may be implemented to address the issue.

Counseling Cafe

Employees are encouraged to raise workplace concerns
through our internal Counseling Cafe,
where we collaborate to find effective solutions.

Counseling Café (KOR)

Social Contribution

We strengthen our community bonds
through social contribution initiatives.

At GC Biopharma, our commitment to social responsibility is driven by our core values of "Care & Compassion" and "Respect & Dedication”. We actively contribute to society through various initiatives, including donating medicines, offering scholarships and research funding, engaging in volunteer activities, support underserved communities, and encourage blood donations. Our goal is to inspire active participation from our employees.

Key Directions for Social Contribution Activities

  • Good Companion

    Fostering sustainable growth with local communities through collaborative activities.

  • Fun+Donation

    Encouraging a culture of giving by incorporating enjoyment into everyday acts of charity.

  • Face to Face

    Expanding face-to-face social contribution activities, while maintaining strong connections with local communities.

Social Contribution Activities

Social Contribution Activities

Quality Policy Statement

GC Biopharma a pharmaceutical manufacturer focused on the research, development and commercialization, has been leading the field of biotechnology in Korea. In addition, GC Biopharma is becoming one of the best international pharmaceutical companies for its outstanding blood and vaccine products. With our mission to devote to the healthy lives of people, our vision to become a global leader in the healthcare industry, and our four core values (Challenge & Innovation, Care & Compassion, Transparency & Integrity, and Respect & Dedication), we at GC Biopharma promise to produce high quality products safely and provide the best services for customer satisfaction. GC Biopharma’s staff members understand the following quality policies and dedicate their best effors to fulfill company’s values and achieve customer satisfaction.

We will:

· Commit ourselves to meeting all regulatory requirements, implementing and maintaining a quality management system compliant with Korea Law and US FDA Regulations and laws enforced by the Code of Federal Regualtions.

· Continually develop and improve our Qualty Management System and compliance with regulatory requirements, thereby ensuring that we always strive to meet our Customers and Stakeholders current and future needs in an effective, efficient and compliant manner.

· Invest in our people and our facilities to achieve a quality culture and environment in which we are all proud to contribute and that delivers high quality products.

· Deliver our commitments to our Customers, on time and to specification.

· Develop our technology, through effective realization of our intellectual property, and partnerships with industry.

· Ensure that we maintain our high international reputation, through parnerships and collaborations.

Eun-chul Huh, CEO of GC Biopharma

Policy for Environment,
Safety and Health

Based on our mission of ‘Making a healthier and happier tomorrow for humanity’, GC Biopharma fulfills the obligations to implement the Environmental, Safety and Health management system,establish and practice ESG strategies for sustainable management and continuously develop them.

  • 01

    Sustainable management through ESG management

    We strive to reduce energy use and GHG emissions at each business site to achieve carbon neutrality by 2050. In order to establish eco-friendly production processes, we track and manage energy usage and waste generation throughout the entire process from manufacturing to postproduction disposal.

  • 02

    Adherence to Regulations on Environment, Safety and Health

    We comply with domestic and international regulations on environmental, safety and health and actively participate in implementing ISO14001/45001 and in establishing prevention systems centered on autonomous risk assessment to eliminate major accidents

  • 03

    Improvement and Prevention Management

    We set clear objectives for environmental, safety, and health management, allocating the necessary resources to continuously identify, monitor, assess, and improve our processes. This approach ensures the elimination of potential risks that could lead to environmental pollution or safety-related incidents.

  • 04

    Environment, Safety and Health Communication

    We foster a mature environmental, safety and health culture where employees can actively participate in environmental, safety and health activities. We strive to create a safe workplace by efficiently communicating with stakeholders including employees, partners, local communities.

May 18, 2023

Eun-chul Huh, CEO of GC Biopharma

Health & Safety
Management Activities

  • 1. Health & Safety Management

    We have established a comprehensive health and safety management system aligned with international standards such as ISO 45001 (Occupational Health and Safety Management Systems) and Process Safety Management (PSM). Covering the entire value chain, including partner companies, this system emphasizes proactive safety measures like joint safety inspections and safety training to prevent and manage accidents. Our top priority is to foster a safe and healthy work environment where all employees can thrive.

  • 2. Workplace Safety Management

    To promote a robust safety culture, we implement our health and safety management system across the organization. All employees receive quarterly mandatory health and safety training, along with job-specific safety measures. These include installing safety equipment, managing Material Safety Data Sheets (MSDS), implementing preventive strategies for occupational diseases, offering first-aid training, and providing stress management programs.

  • 3. Safe Chemical Management

    GC Biopharma is dedicated to preventing environmental harm from hazardous chemicals and protecting the health of its employees. We strictly comply with regulations such as the Chemical Substances Control Act and the Act on the Registration and Evaluation of Chemicals. Every chemical is managed according to safety plans based on MSDS guidelines, covering its full lifecycle from procurement to disposal, to prevent accidents and protect the environment.

    • 01

      Monitoring and identifying new hazardous chemicals

    • 02

      Review and permit requests

    • 03

      Procurement

    • 04

      MSDS registration and management

    • 05

      Storage and usage

    • 06

      Waste management

    *MSDS: Material Safety Data Sheets provide critical information on the safe handling, health hazards, and physical risks associated with chemicals.

  • 4. Employee Health Management

    We offer a variety of programs to promote our employees' health and well-being. Annual comprehensive health check-ups are available to employees and their spouses, and flu vaccinations are provided for all employees and their families.

    We also conduct special health exams and workplace environment assessments for employees handling hazardous chemicals, including non-regular workers. To support both physical and mental health, we provide access to hospitals, fitness centers, and psychological counseling services. Since the COVID-19 outbreak, we have implemented strict disinfection protocols throughout all facilities to ensure a safe environment.

Human Rights Charter

  • 1. No Discrimination

    GC Biopharma is committed to equal treatment and does not discriminate based on gender, age, religion, social status, place of origin, education level, alma mater, marital status, pregnancy, childbirth, or medical history. This principle applies to all areas of employment, including recruitment, wage determination, benefits, training, job placement, transfers, promotions, off-boarding, dismissal, and retirement.

  • 2. Compliance with Working Conditions

    We adhere to the legal working hours in each country where we operate and provide fair overtime compensation in line with local laws. GC Biopharma ensures compliance with minimum wage laws and supports employee well-being through comprehensive welfare programs, including social insurance. Additionally, we maintain a safe workplace and offer flexible work arrangements to promote sustainability.

  • 3. Humanitarian Treatment

    GC Biopharma protects the privacy and personal information of all employees and strictly prohibits any form of bullying, including mental and physical violence among employees. All verbal actions of coercion, abuse, and unreasonable treatment, including bullying, sexual harassment, and violence, are strictly prohibited. Necessary measures are taken, and support is provided to affected stakeholders.

  • 4. Prohibition of Forced Labor

    All forms of forced labor are strictly prohibited. No employee is required to work under threats, intimidation, confinement, or coercion. We do not retain identification documents or any items that could restrict employees' freedom of movement.

  • 5. Prohibition of Child Labor

    GC Biopharma strictly prohibits child labor and verifies the age of all applicants. In cases of employing underage workers, we comply with relevant laws and ensure that educational opportunities are not restricted.

  • 6. Freedom of Association and Collective Bargaining

    GC Biopharma guarantees employees' freedom of association and the right to collective bargaining. We ensure employees' rights to unite, engage in collective bargaining, and participate in collective actions, without fear of reprisal or disadvantage.

  • 7. Assurance of Occupational Safety

    We are dedicated to providing a safe and hygienic workplace. In addition to adhering to national occupational safety regulations, GC Biopharma conducts regular workplace risk assessments to identify and mitigate safety risks. We also provide training to improve employees' awareness of occupational safety.

  • 8. Human Rights Protection of Local Residents

    GC Biopharma respects the environment, safety, and health of local communities and residents in areas where we operate, including during the construction and expansion of workplace facilities.

  • 9. Grievance Handling

    GC Biopharma provides a dedicated, confidential channel for stakeholders to raise concerns. We ensure the anonymity and protection of all grievance submissions and take timely action to address concerns, providing feedback on any actions taken.