Oneness Biotech Co., Ltd.

Drug Quality Management

2024 Important Performance

The manufacturing site passed the API GMP and finished product GMP and GDP inspections by the Taiwan Food and Drug Administration.
Oneness Biotech passed the Medical Devices Quality Management Systems (QMS) from the Ministry of Health and Welfare.
No major violation of laws or regulations regarding medicinal products between 2020 and 2024.
No product quality-related events that are required to be reported between 2020 and 2024.

GMP Certification Issued by the Ministry of Health and Welfare

QMS Certification Issued by the Ministry of Health and Welfare

ISO 13485 Medical Devices Quality Management System Certificate

Quality Policy: Continuous Quality Improvement for Excellence

Put emphasis on talent cultivation, information analysis of new drug research and development and technological innovation.
Focus on meeting customers’ ongoing needs while conforming to all appropriate technical standards, regulatory requirements, and customer quality expectations. Commitment to product quality, safety and efficacy is the cornerstone of Oneness Biotech, and the staff comply with the most appropriate regulations and standards to implement international good practice.
Quality is the responsibility of every employee in Oneness Biotech. From product research and development, regulatory inspection, material preparation, manufacture (including packaging), laboratory testing, product release, to supply chain management on the market side, Oneness Biotech takes the responsibility for checking every link. Oneness Biotech strengthen the product quality through systematic methods and standardized procedures to comply with regulatory requirements in various markets. Use well-defined, standardized and documented operating procedures to scientifically manage the daily work system. Through the effective operation of the quality management system, including the process of continuous improvement in the system and the guarantee of compliance with the requirements of customers and applicable laws and regulations, Oneness Biotech ensures that the company’s products can meet the requirements of customers and applicable standards and regulations.

Objectives of Quality Management

The management representative plan and determine the quality objectives that can be quantified and meet the regulations and product requirements before the annual management review meeting.
To implement quality management system and obtain third-party certification, including ISO 9001 for quality management system and ISO 13485 for medical device quality management system.
To apply a risk-based approach to control the appropriate processes required by the quality management system, and strengthen product quality through systematic methods and standardized steps to meet the regulatory requirements of various markets and customer expectations.

Learn More

Quality Management Structure and Responsibilities

The Company has established a Quality Assurance Center to coordinate the management and supervision of product quality and safety, to ensure that all products comply with applicable laws, regulations, and quality standards.

QA Center Supervisor	Ensure the implementation and maintenance of quality-related systems. Lead product quality-related risk assessments. Ensure that personnel have completed the required training and are assigned according to operational needs.
Quality Assurance Section (QA)	Responsible for the establishment and maintenance of the quality management system, including internal audits, document management, change control, supplier review, and compliance assessment, in order to ensure that the production process and final products comply with GMP and other international standards. Responsible for investigating deviations or abnormal events, assessment of risks, and implementation of continuous improvement measures, to enhance overall quality management performance.
Quality Control Section (QC)	Responsible for the quality inspection of raw materials, processes, and finished products through rigorous analysis and testing, to ensure that products meet the specified requirements for each production stage. Utilize advanced instruments for physical and chemical testing, microorganism testing, and stability testing, and continuously optimize testing technologies, to improve the accuracy and efficiency of quality inspection.

Implementation of Quality Management

Learn More

Pharmacovigilance

Oneness Biotech has created a “Pharmacovigilance System” according to the Pharmaceutical Affairs Act, the Regulations for the Management of Drug Safety Surveillance, the Regulations for Reporting Serious Adverse Drug Reactions, the Guidelines for Filling Out Forms for Reporting Serious Adverse Drug Reactions, the ICH Guideline E2C (R2) on Periodic Benefit-Risk Evaluation Report (PBRER), and so on. The company established the Post-Marketing Drug Quality Monitoring System, which, due to organizational restructuring in September 2023, is now led and coordinated by the Regulatory Affairs Team under the President’s Office. The Quality Assurance Center, the R&D, sales, clinical, and IT departments collaborate to ensure that the system is in normal operation and that all the necessary documents are prepared, archived, and reported as required. During the reporting period of 2021-2024, no serious adverse drug reactions were reported.

Oneness Biotech collects cases of adverse drug reactions through the monitoring system, has created and maintains a report database, and keeps monitoring the safety of the approved drugs, in order to protect patients’ safety and take on responsibilities for its products and to patients using the products.

Procedure for Post-Marketing Drug Quality Monitoring Reports

Ethical Marketing

Sales activities of medicinal drugs in line with WHO Ethical criteria for medicinal drug promotion

Oneness Biotech has formulated the “Codes of Ethical Conduct” and “Marketing and Sales Code of Conduct”. It is required that marketing and sales personnel must comply with relevant laws and regulations and the recognized ethical standards of the pharmaceutical industry. Marketing documents must be internal reviewed to ensure the content is consistent with the indications and in compliance with regulatory requirements. The Company regularly (quarterly/yearly) organizes education and training to educate relevant personnel to sell medicines properly; and shares medical information with medical service providers and patients in an open, transparent, and timely manner to avoid information asymmetry. There was no violation noted in 2024.

Internal Audit and External Verification

To ensure the effectiveness and compliance of its quality management system, the Company adopts a dual mechanism of internal audits and third-party certifications. Through both scheduled and unscheduled audits, we ensure that all departments comply with standard operating procedures (SOPs) and proactively identify and address potential risks.

At least two internal audits are conducted annually, covering key departments such as production, quality assurance (QA), quality control (QC), and warehousing. Departments must implement corrective actions within 30 days for any deficiencies found, while the Quality Management Department tracks progress.

According to the 2024 internal self-inspection plan, the following internal audits were completed:

First Half of the Year: Audits covered the Quality System, Production System, Packaging and Labeling System, and Facilities and Equipment System.
Second Half of the Year: Audits covered the Quality System, Raw Material and Material System, Production System, Laboratory Quality Control System, and ISO 17025 compliance.

※The above content is taken from the ESG Report

ESG

ESG Overview

Corporate Governance

Environmental Protection

Social Inclusion

ESG InfoHub

Product Safety