ESG

Drug Quality Management

 Major Achievements in 2021

• The manufacturing site passed the API GMP and finished product GMP and GDP inspections by the Taiwan Food and Drug Administration
• No major violation of laws or regulations regarding of medicinal products
• No product quality-related events that are required to be reported

Measures to Assess and Manage Quality Safety Risks

• The management of product quality risks is carried out according to such “Risk Management Principles” as PIC/S GMP Annex 20 Quality Risk Management and ICH Q9 Quality Risk Management. The scope of assessment includes raw materials, supplies, finished products, the support system, manufacturing processes, equipment and machines that may affect drug safety, product quality, regulatory requirements, and so on.
• The Risk Priority Number (RPN) is used for risk classification, and risk reduction plans are made accordingly. It is then determined whether the risk events under assessment are acceptable. If not acceptable, the risk reduction plans will be modified according to the “Change Control Procedure” or the “Operating Procedure for Correcting/Preventing Anomalies”.
• Risk assessment is performed on the critical quality attributes (CQA) of products, manufacturing processes, and critical manufacturing process parameters by the SME team members (R&D experts, technology transfer personnel, engineers, QA personnel, and QC personnel), and the assessment results are recorded. Once the corresponding reports are prepared, the responsible departments will be notified to perform preventive or corrective actions on items of relatively high risks until the risks are lowered to acceptable levels.

Quality-Related Education and Training Based on PIC/S GMP and GDP

• The Company places great emphasis on the education and training of employees. Not only must the key personnel defined by law be trained by external institutions and acquire the corresponding credit, but also all the employees are required to complete education and training related to their respective positions and pass the corresponding exams before they are allowed to perform the tasks assigned to them. According to the regulations on internal education and training, training assessment can be carried out through a written exam, an oral exam, and/or hands-on operation, and it is required that the score of assessment be 90 or above.
• To ensure that the staff of the Nanchou Plant have professional knowledge related to the “Good Manufacturing Practice for Medicinal Products” (PIC/S GMP) and the “Good Distribution Practice for Medicinal Products” (PIC/S GDP), the Company has provided a series of courses and has required a total of 12 colleagues associated with manufacture and/or quality assurance to take the courses and pass the corresponding exams. In 2021, this series of courses included 111 courses and had 900 attendances in total.

Statistical Table for Quality-Related Education and Training at Oneness Biotech's Nanchou Plant

Quality Review, Tracking, and Improvement

The Nanchou Plant has an internal audit procedure by which internal audits and tracking are performed to ensure that plant operations meet the requirements of the quality management system and can be carried out continuously and effectively. Quality audits within the quality system shall be scheduled according to the operations of the to-be-audited departments and the importance of the to-be-audited items. In principle, at least one audit shall be conducted per year. The operating procedure for an internal audit and the related documents shall cover the scope, frequency, method, authority, and planning of the audit, the requirements for implementing the audit, and how the audit shall be recorded.

Drug Traceability and Recall

Customer complaints about drug defects shall be dealt with according to the “Customer Complaint Procedure”.

If a customer has a concern or a complaint about drug quality, a cause analysis and liability identification shall be performed according to the corresponding reference sample in the plant, in order to determine whether the customer complaint in question is a quality-related complaint or a non-quality-related complaint. If it is a quality related customer complaint, a comprehensive investigation must be carried out, and corrective/preventive measures taken, in order to close the case.

In order for the drug recall operation to begin, the Quality Management Center is responsible for drafting the drug recall plan. Once the highest-level responsible executives decide to approve the plan, the related sales unit shall work with the logistic companies to check the sale of the batch of products in question, communicate with the customer with regard to the recall of that batch of products, and manage the recalled products and the related sales and distribution documents. At the end of the recall operation, the QA personnel shall prepare a recall report and submit the report to the competent health authority. During the recall operation, the QA personnel shall supervise and follow all the activities in order for the drug recall to be completed by the specified time limit.

Monitoring the Quality of the Environment

The manufacturing areas of the Nanchou Plant are controlled against cross-contamination of active substances, with the flow of people separated from the material flow. All the related facilities, critical public equipment, instruments, and procedures have been validated to ensure compliance with design standards. The temperature, humidity, suspended particles, and pressure difference in the entire plant are strictly controlled to meet specification requirements and to prevent the risk of cross-contamination. A surveillance alarm system is also in place so that the responsible personnel will be notified of any detected abnormality by way of mobile phone short messages. The air conditioners of the grade-D clean room are provided with 99.97% HEPA filters, and the return air system is mounted with 30% pre-filters. All the filters are replaced periodically. An operating procedure for cleaning the factory environment has been established, stipulating the methods and frequencies of cleaning and disinfection of the factory environment.

Drug Storage and Transportation

A “Warehousing Operation Control Procedure” for the warehousing of raw materials, supplies, and finished products has been established according to the PIC/S GMP and GDP specifications. The warehouse Supplies Section is responsible for performing receiving inspection on incoming goods after the goods are unloaded. The receiving inspection includes inspecting the environment around logistic vehicles, confirming the identity of qualified suppliers, counting the items delivered, checking the exterior of incoming goods, and so on. Raw materials, supplies, and finished products shall be stored in the quarantined area or on the quarantined racks (for dried medicinal herb and finished products) in order to be inspected. Items that are determined by QC inspection as conforming shall have their external packaging attached, by the QA personnel, with a label indicating conformity and be transferred to the conforming goods storage area in the warehouse by the Supplies Section personnel.

Product transportation from the Nanchou Plant is entrusted to GDP certified logistic companies to cover the transportation in Taiwan including the remote areas, and for the offshore islands of Taiwan, the transportation is entrusted to the assigned contractors by Kerry Pharma Logistics.

Pharmacovigilance

During the period covered by the 2021 Annual Report, Oneness Biotech had no drug safety-related issue that is legally required to be reported.

Oneness Biotech has created a “Pharmacovigilence 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 Post-Marketing Drug Quality Monitoring System of the Company is led by the Department of Medical Sciences and works in conjunction with the Quality Management Center and the R&D, sales, clinical, and IT departments to ensure that the system is in normal operation and that all the necessary documents are prepared, archived, and reported as required.

Medical personnel, patients, and the caregivers of patients may report information related to the experience of an adverse reaction of a medicament through a sales representative, the customer hotline, or the dedicated email address (medicalscience@onenessbio.com.tw) of the Company. When receiving such a report, the Department of Medical Science is responsible for filling out the Form for Reporting Severe Adverse Reactions of Medicaments; contacting the reporter in order to obtain more detailed information; and evaluating, reporting if necessary, preparing a report for, and updating the Safety Database in accordance with, the reported case according to the “Procedure for Pharmacovigilance Reports”. In addition, the Department of Medical Sciences shall classify, and perform a statistical analysis and trend analysis on, the reported cases on a regular basis, present the classification and analysis results in the “Periodic Drug Safety Report”, and submit the report to the National Adverse Drug Reaction Reporting Center, the Ministry of Health and Welfare according to a specified schedule.

Procedure for Post-Marketing Drug Quality Monitoring Reports

※The above content is taken from the ESG Report