Formosa Laboratories 2022 Material Topic: The Management of Drug Safety
We are committed to providing effective, high-quality products. We have established excellent control systems in supply chain management, production management, quality management, and distribution management through validation operations to ensure drug safety.
FORMOSA
FORMOSA
Management of Raw Materials Supply Chain
Formosa Laboratories requires all raw material suppliers to complete verification and meet the Company's requirements before purchasing raw materials for production. For primary raw material suppliers, on-site audits are required to confirm their quality management systems and production management meet our requirements and can continuously supply highquality materials to meet our production needs. To continuously monitor the supply level of each supplier, we conduct annual reviews of key suppliers to assess their supply stability and, when necessary, takes measures to provide guidance or reaudit suppliers.
Quality Management System and Production Management.
Formosa Laboratories establishes its quality management system and production management system based on the premise of complying with GMP regulations in Taiwan, Europe, America, Japan, and South Korea. Before the products are launched, they all follow regulatory requirements and undergo strict validation operations to ensure the consistent production of safe, consistent, and effective products.
- The Company conducts strict stability tests on products to ensure their quality during their shelf life or retesting period.
- To continuously monitor the production status and quality level of various products on the market, an annual review of the products is conducted each year to assess their product yield, process control capability, change control, abnormal investigation, and corrective and preventive actions, in order to achieve continuous improvement and optimization.
- To effectively manage and track quality management activities, we have been at the forefront of the industry since 2012 in implementing the advanced TrackWise computerized quality management system. This computerized system is used to manage changes, deviation, customer complaints, supplier audits, corrective and preventive actions, and effectiveness verification.
Formosa Laboratories undergoes approximately 40 official and customer audits each year, all of which have received positive feedback. As of the end of 2022, the Company has obtained GMP compliance certifications from the Taiwan Ministry of Health and Welfare, the U.S. Food and Drug Administration, and the Japan Pharmaceuticals and Medical Devices Agency. In addition, we successfully passed the inspection conducted by the U.S. Food and Drug Administration in 2022 with No Action Indicated. We continuously maintain our pharmaceutical quality system to ensure that our products meet the requirements of quality, safety, effectiveness, and other GMP standards.
In accordance with relevant regulations, the Company has evaluated the prohibition and control of hazardous substances, including residual solvents (ICH Q3C (R3)), transmissible spongiform encephalopathy (TSE)/bovine spongiform encephalopathy (BSE) (EMA/401/01 rev.3), allergens (EC Directive 2000/13/EC; FALCPA 2004-21 USC 301), elemental impurities (ICH Q3D; USP/), non-genetically modified raw materials, aflatoxin risk, nitrosamines, raw materials that do not contain galactomannan/gluten/latex/melamine, genotoxic impurities, heavy metal residues, plasticizers, and other control requirements. This evaluation ensures that all products of Formosa Laboratories do not harm the health and safety of users and the environment. The Company has not violated any health and safety regulations regarding products and services in 2022. Chapter 3 Supply Chain Management Formosa Laboratories, Inc. Sustainability Report 101
Distribution Management
Formosa Laboratories is committed to the safe distribution and quality control of products. It formulates relevant specifications for all activities related to drug procurement, storage, supply, import, or export, and prevents counterfeit and Prohibited drugs from entering the legal supply chain.
Our factory has a high standard quality management system, and our employees have obtained the GDP Pharmaceutical and Medical Device Distribution Manager License. In terms of product distribution tracking, transportation conditions, temperature control, and anti-counterfeiting labeling, we ensure the control of the distribution supply chain. We also select vehicles and equipment suitable for the transportation, storage, or handling of drugs, installing appropriate equipment to prevent drug damage and product exposure to potential risks that may affect quality. All distribution activities comply with the requirements of Good Distribution Practice (GDP), ensuring the maintenance of quality and integrity of drugs during distribution process, and passing the GDP inspection conducted by the Food and Drug Administration of the Ministry of Health and Welfare.
Product Labeling
To implement product safety management,Formosa Laboratories invests a significant amount of resources in ensuring product safety throughout the processes of research and development, production, storage, and labeling. In addition to implementing safety measures corresponding to the different specifications of the Company's products, detailed and specific information is legally labeled on the products, including the Company's name, address, contact number, product name, weight, product batch number, manufacturing date, retest period/expiration date, storage conditions, and special precautions. The labeling materials are strictly controlled to prevent labeling errors and the possibility of counterfeit drugs, and they comply with local regulations regarding product information and labeling requirements, ensuring the protection of users and transportation safety. During the reporting period, the Company did not violate any regulations regarding the information and labeling of products and service.