Value Chain Management
Pharmaceutical Quality Management
To ensure stable product quality and protect users' health and safety, Formosa Laboratories has invested an abundance of resources in R&D, production, storage, transportation, and sales to the end-use stage in building a quality management system for our own products.
Formosa Laboratories has also recorded our quality commitments in our quality manual. All our production processes have gone through stringent validation to ensure the safety of our pharmaceutical products.
Customer Service
Formosa Laboratories considers customer feedback a vital foundation for enhancing customer relationship development. We gather insights about customer needs through various channels, including video conferences, business visits, and participation in exhibitions. During customer visits, we begin by surveying customer needs. If there is a service deficiency, we identify the issues customers face, investigate them with the relevant department, and then implement corrective and preventive actions (CAPA) to explain the situation to customers. Regarding customer suggestions, we regularly review and analyze them in meetings and propose appropriate improvement plans to establish a comprehensive procedure to address customer needs.
To ensure excellent customer service and maintain high product quality, Formosa Laboratories adopts a two-stage investigation process in the event of customer complaints. Investigations are conducted based on structured procedures and findings, with issue clarification carried out at each stage to develop effective preventive measures, stabilize product quality, and reduce the risk of recurrence. For any complaints initiated by customers due to abnormalities related to activities performed under GMP standard operating procedures (SOPs), the company responds in accordance with those procedures.
Stage 1 : focuses on verifying whether the complaint is substantiated. The investigation is completed within 10 days, and a report is provided to the customer.
Stage 2 : aims to identify the root cause of the issue and propose corrective and preventive actions (CAPA). This phase is completed within 30 days.
▼Execution rate of investigations of customer complaints at Formosa Laboratories in the last three years
| Year | 2022 | 2023 | 2024 |
|---|---|---|---|
| Number of customer complaints | 18 | 19 | 15 |
| Execution rate* | 94.4% | 94.7% | 86.7% |
- Execution rate : Number of customer complaints investigated within the operation schedule / Total number of customer complaints in this year.
- Information restatement : The information was restated due to the adjustment of the data calculation method.
Exchanges through International Exhibitions
By participating in international exhibitions, Formosa Laboratories has been able to maintain active communication and interaction with customers, suppliers, and industry peers. This not only helps us stay updated on the latest trends and technological advancements in the global pharmaceutical industry, but also allows us to keep track of changes in market demand and consumer preferences.
In 2024, Formosa Laboratories participated in a total of six international exhibitions, gaining valuable experience throughout the process. We aim to transform this experience into “nutrients” for our product development and operational strategies, with the goal of consistently increasing our product value and maintaining our core competitive edge in a highly competitive market.
▼ List of international exhibitions Formosa Laboratories
participated in in 2024
| Location | Exhibition Event | Event Period |
|---|---|---|
| USA | DCAT week | 2024/03/18～03/21 |
| Bio US | 2024/06/03～06/06 | |
| Japan | CPhI Japan | 2024/04/17～04/19 |
| China | CPhI China | 2024/06/20～06/21 |
| Taiwan | Bio Asia | 2024/07/25～07/28 |
| Europe | CPhI WW 2024 | 2024/10/08～10/10 |
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.