★Institution and Personnel Management

We have established organizations suitable for GMP management. Anyone is not allowed to take concurrent position in charge of the production department and quality control department. The person in charge of quality control is an engineer and licensed pharmacist, who holds undergraduate degree and has worked on drug management for more than 20 years. The person in charge of production is an engineer, who hold undergraduate degree and has worked on quality control for pharmaceutical production for over 20 years.

★Factory and Facilities Management

The factory is laid out properly. Areas for different purposes are divided. There is not any pollution source nearby. The green coverage and roads in the factory meet the GMP production requirements.

The area of the lab is 768 square meters. It is laid out properly and contains complete laboratories. The instruments are examined and calibrated by the metrological department on a regular basis. According to the related rules, the warehouse is divided to finished product warehouse, raw material warehouse, hazardous substance warehouse and etc. The distribution and storage of materials and the state labels for up-to-standard products and products to be inspected are clear. There are areas for failed products and returned goods.

★Equipment Management

The design, model selection and installation of equipment meet the requirements of the production process. It is easy to clean and sterilize. The model selection and precision of the devices, meters and weighing apparatus meet the production and inspection requirements, which are examined and calibrated by provincial, municipal metrological institutions and statutory testing institution on a regular basis and are affixed with certificates of passing verification. All equipment, instruments and weighing apparatus come with corresponding operation, maintenance and repair process. The equipment are managed by specific persons and repaired and maintained on a regular basis with corresponding records.

★Material Management

The warehouse is divided to different areas clearly without causing any cross contamination. Sampling is done with a clean sampling vehicle of cleanness level 300,000, which can satisfy the sampling requirements of interior packing materials. All our raw material suppliers and auxiliary material suppliers are qualified and reputed and have passed audit.

Raw materials and auxiliary materials below standards will not enter the area for up-to-standard products. Below-standard materials are attached red signs and are disposed according to the rules on the management of below-standard materials.

★Quality Management

We have Quality Assurance Department, which has QA, QC and GMP office under it. The Quality Assurance Department reports to the general manager and is responsible for the quality monitoring and inspection throughout the pharmaceutical production process. The QA is responsible for the quality monitoring throughout the production process, quality audit of the suppliers, supervision over the production process, complaints of product quality, and report on adverse reactions. The QC is responsible for the inspection of raw materials and auxiliary materials, intermediates, finished products, process water and air cleanness level of the entire factory and preparation of test reports. At the end of each year, the GMP office carries out self-examination and prepares a self-examination report. In case of any defect is found during the self-examination, it will be corrected within a certain period of time and the correction result will be followed up.

★Production Management

We have made process rules, standard operation procedures for all products according to their certified process. In case of amendment, it must be approved according to the related documents and verified correspondingly. If the process changes significantly, we will inform the customer in advance and report to the local food and drug administration for approval and filing.

The production lot record is designed and prepared according to the process rules and standard operation process and will be organized and filed one more year after the expiration date according to the rules. Referring to the production lot number, we can retrospect the entire production process of the batch of the products, including the influence of the starting raw materials and auxiliary materials.

The preparation of the lot number meets the requirements and follows strict written rules.

★Documentation and Record Management

We have established a relatively complete quality management documentation system. Documents and records involve all aspects of GMP management. All activities related to production, quality, storage and transportation are all specified in the documentation system. All activities can be attested with documents and records. The preparation, examination, approval, distribution, taking back and destroying of documents all follow procedures and are recorded.