Drug Quality Management
Major Achievements in 2022
- 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 (2019-2022)
- No product quality-related events that are required to be reported (2019-2022)
- No product recall (2019-2022)
|Quality Policy: Continuous Quality Improvement for Excellence|
|Objectives of Quality Management|
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, legal requirements, and so on.
The Risk Priority Number (RPN) is used for risk rating, 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 group 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 operations 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 all Nanchou Plant colleagues to take the courses and pass the corresponding exams.
Quality Review, Tracking, and Improvement
The Nanchou Plant performs an annual product overall evaluation according to the “Standard Operating Procedure for Annual Product Quality Review”. At the beginning of each year, a product quality review report for the products produced in the previous year shall be completed.
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 counterfeit drug or prohibited drug is suspected, the logistic companies and those responsible for quality assurance in the Company shall be informed within 24 hours, and the sale and distribution of the batch involving the suspected counterfeit or prohibited drug shall be stopped. The stock of the batch in question shall be stored in a concentrated manner and physically isolated to prevent misuse. The QA personnel shall conduct a deviation or customer complaint investigation, reconfirm the package identification of the corresponding stock, sample the stock, and perform a total chemical analysis on the sample in a lab to determine the drug as genuine, counterfeit, or prohibited. If the analysis result reveals the drug as a counterfeit or prohibited drug, a drug recall operation shall begin immediately.
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.
If no recall operation has taken place in the entire year, the Quality Management Center shall initiate at least one simulation audit and prepare the corresponding simulation audit plan in order to link the operations of the related departments of the Company to the market-end operations according to the plan.
Monitoring of Environment Quality
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 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.
During the 2021-2022 reporting period, an adverse event (rash) occurred, related to Fespixon® cream, which was an expected non-serious adverse drug reaction (recorded in the medication package insert), and it has been notified to the Taiwan National Adverse Drug Reactions Reporting System.
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 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 (firstname.lastname@example.org) 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
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. In 2022, there was no incidents of drug sales customer complaints.
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 2022.
※The above content is taken from the ESG Report