Quality assurance overview
Company set up quality department, under the QA regulation of independent of the production system, follows the GMP regulations, responsible for the whole process of production quality control and quality management, improve product quality, to meet customer and market needs.
In order to better do a good job in quality management company, workshop, the team set up specially, part-time quality inspection personnel, set up effective three-level quality monitoring network system, give full play to the supervision function, based on the supervision and inspection, by means of quality rewards and punishment, in order to meet market and customer demands for the advanced level at home and abroad were leveraged, with GMP standard, strengthen the production process quality control, ensure the quality of products.
In the process of cooperating with customers, the QA system of the company accepted and passed the audit of dozens of domestic and foreign pharmaceutical enterprises and received unanimous praise. In addition, the company also has rich experience in product registration, completed a number of products as the starting material, the quality of the key intermediates and advanced intermediates package file system file system, technology, and comply with European pharmaceutical factory finished EMA intermediates registration work.
The company has obtained the following certification:
• ISO 9001:2008 quality system certification.
• ISO 14001:2004 environmental management system certification.
• OHSAS 18001:2007 occupational health and safety management system certification.
Analysis instrument overview:
Company quality inspection center is equipped with detection instruments that meet the needs of production and testing equipment, which is equipped with advanced imported infrared spectrometer, high performance liquid chromatograph, gas chromatograph, ultraviolet spectrophotometer, potentiometric titration, such as precision analysis instruments, to ensure the accuracy of detection. It also has a polarimeter, spectrophotometer, moisture meter, melting point meter, drug stability test box, high precision electronic sky equality. Through the use of the public platform NMR, lc-ms, the preparation of HPLC and the high efficiency lyophilizer and other equipment, the identification and separation of impurities were completed.