The Guangdong-Macao Pharmaceutical Co., Ltd. has drawn up a Quality Handbook, as well as regulations and technical documents, in accordance with China’s Good Manufacturing Practice for Drugs (2010 Revision), the EU Good Manufacturing Practice, the Pharmaceutical Quality System (ICH10) and Quality Risk Management (ICHQ9). The Quality Handbook is a guiding document for the company’s quality management system, the regulations provide reference and principles for its staff in their performance of work, and the quality standards are the very basis of quality assessment. All working procedures and operating steps of the company follow the Standard Operating Procedures (SOP) as approved in writing. All manufacturing activities are recorded in real time and traceable. On the basis of the documents for quality management, the Guangdong-Macao Pharmaceutical Co., Ltd. has put in place an appropriate executive body and made clear the responsibilities of each department and post. The General Manager is in charge of the company, the Manufacturing Director is in charge of manufacturing management, and the Quality Director is in charge of quality management. There are seven departments under the company, namely the Quality Department, the Manufacturing Technology Department, the Materials Department, the Equipment and Power Supply Department, the Human Resource and Administration Department, the Marketing Department, and the Finance Department. Responsibilities of each post are not omitted or overlapped. All personnel are well aware of their own duties and familiar with the requirements for such duties. Each post involves pre-job training and appraisal to ensure staff’s appropriate performance of duties.

The solid preparations workshop covers a construction area of 2,670 square meters. It follows relevant GMP requirements of the EU and China and practices the ideas of intelligent manufacturing and lean manufacturing. The workshop, which produces four types of oral solid preparations, namely tablets, capsules, granules and pills, is capable of pilot scale production and production for sale. It has imported advanced equipment from Bosch, Fette, IMA, Marchesini and Fitzpatrick from Germany, Italy and the US. All equipment can be controlled intelligently, which automatically records manufacturing parameters and generates electronic records that meet the relevant requirements of FDA 21 CFR Part 11 on electronic data.

The quality analysis center covers an area of 2,670 square meters. Equipped with an atomic absorption room, a gas phase room and a liquid phase room, it can be used for microbe testing, instrumental analysis, and physical and chemical testing. It has 93 types of approximately 200 testing machines used for the testing of active pharmaceutical ingredients, pharmaceutical excipients, packing materials, semi-products and finished products in the process of pharmaceutical manufacturing. It is qualified for all kinds of tests in accordance with ChP, BP, EP and USP.