Drug Quality Management
Oneness Biotech introduces ISO 9001 Quality Management System, and obtains the third-party certification.
- The Nanchou Plant has passed the GMP and GDP inspection of APIs and pharmaceutical preparations by the Ministry of Health and Welfare
- No critical violation of relevant good drug practices and regulations has occurred
- No incidents related to product quality that must be notified have occurred
Quality and Safety Risk Assessment and Management Measures
Product quality risk management is implemented in accordance with the “Risk Management Principles” formulated by PIC/s GMP Annex 20 Quality Risk Management and ICH Q9 Quality Risk Management. The assessment scope includes raw materials, finished products, support systems, manufacturing processes, equipment and machines that will affect drug safety, product quality, and regulatory requirements.
Use 5W1H or other risk assessment tools such as fishbone diagrams to identify and analyze risks. Use Risk Priority Number (RPN) for risk classification (i.e., risk evaluation) and then establish a risk reduction plan: confirm whether the assessed risk event is acceptable. If it is unacceptable, design a risk reduction plan based on the “Change Control Procedure” or “Abnormal Deviation, Correction and Prevention Operation Procedure”.
A risk assessment has been carried out for the Critical Quality Attribute (CQA), Critical Process Parameter (CPP) and process flow. The assessment is carried out by team members of the SME (R&D experts, technology transfer personnel, process personnel, engineering personnel, QA, QC, etc.). The assessment results are recorded in a report, and the responsible unit is notified to carry out corrective and preventive operations for the higher-risk projects to reduce the risk to an acceptable level.
PIC/S GMP and GDP Quality Education and Training
The company attaches great importance to the professional training of employees. In addition to the key personnel in accordance with the regulations to receive training and get credits from external units, it also requires all personnel to complete the education and training corresponding to their duties and pass the assessment before they can independently perform their assigned tasks. According to the regulations of the internal education and training standards, training assessments must be conducted through written examinations, oral examinations, and practical examinations, and the score must reach 90 points or more.
In order to make sure that all Nanchou Plant colleagues are familiar with and conform to the “Good Manufacturing Practice for Medicinal Products (PIC/S GMP)”, “Good Distribution Practice for Medicinal Products (GDP)” and Quality Management Systems and other related professional knowledge, the company holds a series of related courses and requires all relevant personnel to take part in and pass an exam. This course series has a total of 233 courses, with a total of 1344 class attendees.
Drug Traceability and Recovery
Through an effective drug traceability mechanism, the drug safety for patients can be strengthened and guaranteed. Each batch of product is assigned a batch number or product serial number, and records of its incoming inspection (parts and components that are important to safety), production and inspection are retained. When a quality issue occurs, various records can be used to trace the production and inspection status of the product at that time as reference information for customer complaint investigations, handling, and corrective measures.
Customer complaints of defective drugs shall be handled in accordance with the Customer Complaint Handling Procedure. If there is any doubt regarding drug quality, take the control sample in the plant for root cause analysis and responsibility determination, and confirm it as a quality customer complaint or a non-quality customer complaint. If it is a quality customer complaint, the case can only be closed after a comprehensive investigation and corrective and preventive measures have been completed.
If there is a suspected counterfeit and prohibited drugs, the logistics provider and our quality assurance personnel should be notified within 24 hours, and the batch sales and distribution of the suspected counterfeit and prohibited drugs should be halted. Relevant batches of inventory must be centralized and managed with physical isolation to prevent misuse. Afterwards, quality assurance personnel need to initiate a deviation or customer complaint investigation, and perform inventory packaging identification again and take samples to the laboratory for full analysis and testing to identify the authenticity of the drug or the counterfeit and prohibited drugs. If the test result confirms a counterfeit and prohibited drugs, it is necessary to immediately start the drug recall operation.
Environmental Quality Monitoring
The maintenance and monitoring of the production and warehousing environments are crucial to product quality and safety. The manufacturing area of the Nanchou Plant has implemented the control of cross-contamination of active substances with the separation of the flow of people and logistics, related facilities, key utilities, and equipment and procedures. These methods have been validated to ensure compliance with design standards. The area temperature, humidity, suspended particles, and differential pressure are controlled to meet the requirements of laws and regulations to avoid confusion and error, and to avoid the risk of cross-contamination, and a monitoring alarm system is set up to notify responsible person of abnormal occurrences via mobile phone text messages. Air conditioners in Grade D clean room are equipped with 99.97% HEPA filters, and the return air is filtered through a 30% pre-filter, which is replaced regularly. A “Plant Environment Cleaning Operation Procedure” is formulated to define the method and frequency of plant environment cleaning and disinfection.
Drug Warehousing and Transportation
Raw material and warehousing management are implemented in accordance with the PIC/s GMP and GDP standards, and the established “Warehousing Management Procedure” are implemented. After unloading the goods, the Material Management Section personnel will perform the incoming inspection operation, including the environmental inspection of the logistics transportation vehicles, the confirmation of qualified suppliers, the quantity count, and the appearance inspection of the goods. Raw materials, intermediate materials and finished products are first stored in the waiting area or on (dry materials or finished products) shelves for inspection. After the qualified products passes the quality control inspection, the quality assurance personnel will stick the quality passed labels on the outer packaging of the qualified products. The Material Management Section personnel shall be moved to the qualified products warehouse for storage.
Drug Safety Monitoring
A “Post-Marketing Quality Surveillance System of Medicinal Products” has been established under the leadership of the Medical Science Department and in coordination with related units such as the Department of Quality Assurance, Research and Development, Sales, Clinical Trials, Information and Technology, etc., to ensure standard operating status, and various documents are in accordance with regulations for record filing and reporting.
Healthcare personnel, patients, or caregivers of patients can report information about adverse drug reactions through the company’s salesperson, customer service hotline, and dedicated email (email@example.com). After receiving the reporting, the Medical Science Department is responsible for initiating the Adverse Drug Event Report Form and contact the reporter to obtain more detailed information. At the same time, according to “Post-Marketing Quality Surveillance and Reporting Procedures of Medicinal Products,” the reporting case is evaluated, necessary reporting is made, report writing is initiated and input into the Safety Database is carried out.
Post-Marketing Quality Surveillance and Reporting Procedures of Medicine Products
Strategies and Actions for Access to Medicine
The core business of Oneness Biotech is the development of new drugs, and it adheres to the operation philosophy of compliance with laws and regulations, integrity and transparency. The ultimate goal of Oneness Biotech for Access to Medicine is to enable patients to obtain the drugs they need in a reasonable, affordable, correct, and easy way. With elite talent, innovative technologies, sufficient funds, and the resolute operation philosophy of developing new drugs, Oneness Biotech continues to promote the research and development of new drugs. Combining professional expertise and patented technology, we continue to work hard to develop global innovative drugs to help patients reduce or no longer suffer from diseases.
A. Governance of Access
Oneness Biotech upholds its corporate mission of “Developing New Drugs and Caring for Life.” In addition to focusing on the development of new drugs, we also attach importance to issues for the right to health and invest resources in “Access to Medicine”. Taking Fespixon Cream as an example, Oneness Biotech obtained a Taiwan drug license for this new DFU drug in 2021 and the company has immediately started to develop a plan for Access to Medicine to explore other indications for the use of Fespixon and set a target for new indications of the drug. The company plans to obtain a global drug license by 2025, and by then the benefits and impact of the Access to Medicine will continue from Taiwan to the rest of the world. At present, the relevant policies and specific results for the management of Oneness Biotech’s Access to Medicine are briefly described as follows:
- Ethical Corporate Management
Oneness Biotech has a clear and assessable “Ethical Corporate Management Best Practice Principles” and “Procedures for Ethical Management and Guidelines for Conduct,” which requires that Oneness Biotech’s management and employees shall not be involved in dishonest business behaviors such as corruption, political donations, etc., and must not violate the original intention of the Access to Medicine. The Principles and Procedures are implemented through the company’s rigorous internal audit and monitoring mechanism.
- Internal Audit
Internal Audit Department of Oneness Biotech is subordinate to the Board of Directors and is an independent internal audit unit. It regularly reports to the Audit Committee and also attends board meetings to report to the Board of Directors. If a major violation is found, a report will be made for approval immediately, and the independent directors of the Audit Committee shall be notified.
- Comply with WHO Code of Ethics for Medicinal Drug Promotion
Oneness Biotech has formulated the “Codes of Ethical Conduct” and “Marketing and Sales Code of Conduct,” which regulates that marketing personnel and salesperson must comply with relevant laws and regulations and recognized ethical standards in the pharmaceutical industry. All marketing and sales activities must be conducted in a proper manner, and adhere to the principles of openness, transparency, and immediacy. The company loves sharing medical information with healthcare personnel and patients to avoid information asymmetry, which may result in obstacles to the Access to Medicine.
- Corporate Social Responsibility
Oneness Biotech actively participates in the issues for Access to Medicine, and cooperates with public welfare organizations and external associations to promote the health and well-being of the public. For example, the company has produced public health education videos, including “What is DFU?”, “Caring for feet” and “Diabetic foot ulcer management” so that the public and diabetic patients can better understand the occurrence of diabetic foot ulcers and gain a correct understanding of timely attention and early diagnosis and treatment. For diabetics, if a tiny wound is carelessly neglected, it is likely to result in severe amputation or death. The “Caring for feet” public education video, chaired by the three major medical societies, the Taiwan Society for Burn Injuries and Wound Healing, Taiwan Society for Wound Care, and Taiwan Society of Plastic Surgery, to jointly urge diabetic patients to have regular foot examinations. When foot ulcers occur, seek medical treatment early. Our goal is to expand the influence of public welfare, make efforts to improve patients’ knowledge of health and education, and protect patients’ rights and interests for drug use.
B. Research & Development
The medicines currently being actively researched and developed by the Oneness Biotech R&D team are all global innovative drugs that are best in class, first in class or an unmet medical need. After successful development, they can fulfil unmet medical needs.
- R&D Projects
Oneness Biotech currently has seven research projects, including six that are the development of new drugs in the fields of diabetes, asthma, liver cancer, and anti-infection, namely Fespixon (ON101), F8825, FB704A, OB318, FB918 and SNS812. These diseases belong to the scope of 82 diseases included in the 2021 Access to Medicine Index (see: Access to Medicine Index 2021, page 213, TABLE 3. Diseases, conditions and pathogens in scope of the 2021 Access to Medicine Index, issued by Access to Medicine Foundation in 2021. Website: clicke here), the successful development of new drugs in the future will contribute greatly to the health and well-being of the public.
Take the new drug for Diabetic Foot Ulcer (DFU) “Fespixon” as an example. This is the first-in-class DFU drug. Diabetic foot ulcers are the leading cause of disability and death in diabetic patients. If the ulcers are not properly taken care of, patients will need to have amputation surgery. According to statistics, every 20 seconds in the world, one diabetic patient is undergoing lower extremity amputation, and the five-year survival rate after surgery is less than 60%. Since 1997, the U.S. FDA has only approved one DFU drug on the market. The international Phase III trials of other drugs have all failed. After 13 years of relentless efforts, we finally passed the New Drug Application (NDA) of the Ministry of Health and Welfare in Taiwan, obtained the drug license and it was launched in the market in 2021, bringing the hope of a new treatment to the urgent unmet medical needs for diabetic foot ulcers.
- R&D Subsidies
After the market approval of “Fespixon”, the company encourages medical researchers to conduct more in-depth basic academic research or clinical application of “Fespixon” in the treatment of diabetic foot ulcers or other difficult wounds through the “Regulations Governing the Subsidy for Research Projects”. A subsidy of NT$2 million will be provided for innovative and leading research projects to encourage the academic and research field to participate in academic or clinical application research to better understand the other mechanisms of “Fespixon” and expand possible indications. As of June 2021, 12 medical centers have submitted applications for research projects. At the same time, the company also announced the “Regulations Governing Incentives for Research Papers” to encourage the use of “Fespixon” for basic research, clinical applications or educational promotion of diabetic foot ulcers or other difficult wound treatments. According to the international SCI grade of the paper, grants ranging from NT$5,000 to NT$1 million will be awarded.
C. Product Delivery
Once products of Oneness Biotech obtain a drug license, the company works to expand its product delivery to Access to Medicine. It is hoped that the products can benefit patients in need in different countries around the world to the greatest extent.
- New Drug Application
In order to allow patients in other countries to use “Fespixon Cream” as soon as possible, the company has adopted the following strategies:
After obtaining the Taiwan drug license and according to the two-stage plan, apply for the drug license and market access to Southeast Asian countries with the Certificate of Pharmaceutical Product (CPP). The first stage is Singapore, Malaysia and Thailand, and the second stage is Vietnam, the Philippines, Indonesia and India. The company also submitted the drug license application in China, and complete the CDE’s technical review by June 2021. For the scope of the global market, Fespixon has been granted a Fast Track designation by the U.S. FDA, which provides Expanded Access. The relevant application instructions and contact information have been provided on the compay’s website and the U.S. FDA designated website to enable American doctors to apply for the drug based on the needs of patients so that the drug can be accessible and benefit the patients prior to approval for marketing. In addition to the above, the company is evaluating the named patient program for the countries where new drug application has yet been filed, in hope helping patients receive effective and appropriate treatment.
- Strategy for Access to Medicine - Long-Term Donation plan
Oneness Biotech announced the “Policy for the Medical Subsidies for Low-Income Diabetic Foot Patients” to provide free “Fespixon” to help low-income patients suffering from diabetic foot ulcers.
- Strategy for Access to Medicine - Prescription Drugs
Regarding drug pricing, an international consulting company has been commissioned to perform analysis of the pricing recommendations of insurance companies, professional healthcare personnel and other professional advice for the purpose of setting the optimum range of global pricing for the major markets. In the future, the respective country’s GDP will be used as a parameter to set appropriate local drug prices for different markets.
- Build Capacity
Oneness Biotech has built its Fespixon production base in Nanchou Township, Pingtung County, Taiwan, with operations including the contract farming of raw materials for botanical drugs, extraction and formulation, and to finished products. The capacity can reach 25 million doses a year, which is enough to supply for the demand of the drugs in the next several years. The production base has sufficient space for the second and the third production line expansion to ensure that the future supply of drugs for the patients is assured.