ESG

Product Safety

Drug Quality Management

 

2023 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 of medicinal products.
  • No product quality-related events that are required to be reported.

 

GMP Certification Issued by the Ministry of Health and Welfare
GMP Certification Issued by the Ministry of Health and Welfare
QMS 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
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.

 


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 2022-2023, 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

 

上市後藥物品質監控通報程序


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 share medical information with medical service providers and patients in an open, transparent, and timely manner to avoid information asymmetry.

 

Ethics Audit

Oneness Biotech set up an Audit Office under the Board of Directors as an independent audit unit. The Company conducts Ethics Audit in accordance with the “Marketing and Sales Code of Conduct” and “Codes of Ethical Conduct”, and the internal audit unit regularly reports the inspection results to the Audit Committee and the Board of Directors. Major violation cases should be reported immediately to the members of the Audit Committee and transparently disclosed in the ESG report. There was no violation noted in 2023.

※The above content is taken from the ESG Report

 

 

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