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位元堂

About Company
GMP

Originally founded in 1897 in Guangzhou, Wai Yuen Tong Medicine Co. Ltd. was first relocated to Hong Kong in 1952. As a continuing effort to achieve products of the highest possible quality, the Company has moved to a new Pharmaceutical Manufacturing Facility in 2004. The new Pharmaceutical Manufacturing Facility is located at the Wai Yuen Tong Building in Wang Kwong Road , Kowloon Bay. With a total floor area of 5 storeys, covering over 7500 square meet, the facility consolidates the company's medical ingredients pre-processing plant, manufacturing and packaging operations, QC laboratories, and warehouses, etc. under one roof. All products in oral solid dosage format, including large honey pills, water honey pills, capsule pills and medical powders, are produced at the facility.

Wai Yuen Tong Medicine Co. is committed to the manufacture and supply of traditional Chinese medicine products of the highest quality. The operation of the Pharmaceutical Manufacturing Facility therefore complies with the standards stipulated by the Hong Kong GMP Guidelines for Proprietary Chinese Medicines and the Code of Good Manufacturing Practice for Therapeutic Goods issued by the Therapeutic Goods Administration, Australia.

Manufacturing Plant and Facilities
Wai Yuen Tong is the first Chinese pharmaceutical manufacturer in Hong Kong to have its proprietary GMP plant, equipped with the most sophisticated production and lab testing facilities. In addition, all production, testing and distribution processes strictly adhere to the Standard Operation Procedures laid down by the plant. Design and construction of the GMP plant is done by the Hong Kong Institute of Biotechnology, taking into considerations the materials, personnel and process flow, unit operation and containment to ensure cleanliness in the environment and to prevent product cross-contamination. For instance, unit operations are segregated from other departments by using a modular cleanroom unit design, thereby allowing flexibility in multi-product processing while providing a high degree of assurance on product quality. In addition, each cleanroom zone or unit deploys dedicated heating, ventilation and air-conditioning systems in order to avoid any potential cross contamination via the indoor air circulation.

Wai Yuen Tong's pharmaceutical manufacturing facility complies with the cleanroom and laboratory standards stipulated by the Hong Kong GMP requirements and Code of Good Manufacturing Practice for Therapeutic Goods issued by TGA Australia. Furthermore, the facility is constructed and operated with reference to various guidelines, including:

•  Hong Kong Good Manufacturer Practice Guidelines (1995);
•  ISO 14644, Cleanrooms and associated controlled environments
•  Baseline Pharmaceutical Engineering Guide, volume 2, “Oral Solid Dosage Forms” (ISPE)

In addition, the cleanroom has the strictest requirements in environmental control, in terms of temperature, humidity, air ventilation, air pressure, airborne germs and dust, ensuring that cleanliness of all cleanrooms meet the requirements of the International WHO 100,000 Standards (for oral solid dosage medical products). With regard to the facilities, each cleanroom is equipped with up to 40 types of automated production and auxiliary systems. These include:

1. High Ventilation Air Conditioning System
2. Water/Oil-free Air Compressing System
3. Double-Pass Reverse Osmosis Purified Water System
4. Centralized Dust Collecting System

In terms of the Quality Control, the biological laboratory has also included a number of medical testing equipment, such as:

•  HPLC Spectrophotometer
•  ICP-OES
•  TLC Spectrophotometer with scanner
•  UV/Visible Spectrophotometer
•  Stability Chamber
•  Total Organic Carbon Analyzer

Quality Management System
A designated Quality Assurance System is established to monitor all ongoing activities within the manufacturing facility and to prevent product mix up and contamination. Procedures for the discovery, reporting and corrective actions of all defects or other unsatisfactory conditions at the earliest possible point of detection are also laid down clearly. In addition, the company periodically conducts staff training, internal evaluation, product stability tests, as well as product and facility inspections, giving full assurance of our product quality to our prestige customers.

 

 


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