Company Quality System Introduction
Introduction to the quality system of Tianyu: it has established a quality management system, where the quality team is managed by the person in charge of quality under the direct leadership of the companys president, and the quality management department and the quality control center have been set up to be responsible for quality management, quality supervision, and quality inspection respectively.
The quality control center is provided with complete and advanced detection instruments and an online data processing system that meets the requirements on data reliability. It has developed inspection management procedures and product quality inspection procedures, and set up the inspection team qualified for training and requirements, and it organizes inspections on raw and auxiliary packaging materials, intermediates, and finished products in an orderly manner to ensure the accuracy and reliability of product quality inspection data.
In strict accordance with the requirements of GMP and ISO9001, as well as the complete quality management manual and management procedures, the company takes GMP as the criterion to regulate and consummate the various production and quality management procedures, for which, a full-time QA team has been established. It also organizes full-person training and retraining, pays attention to the improvement of personnel quality, conducts whole-process management and supervision from supplier assessment, material warehouse entry acceptance, production process, quality inspection, product release, sales, customer service, etc., organizes daily on-site inspections, deviation processing and change control, makes the annual product quality review and trend analysis, carries out GMP/ISO9001 self-inspections regularly organized, and achieves continuous improvement through corrective and preventive measures; By virtue of the comprehensive guarantee on product quality, our products have won a good reputation in both international and domestic markets.
The company has passed ISO9001/GBT19001 certification to quality system, and as well as the supervision and audit annually; both the headquarters and Linhai Tianyu Subsidiary passed the GMP on-site inspections of CFDA, USFDA, EU or JAZMP, a member of EU. It also passed the GMP on-site inspection by Australia TGA, Japan PMDA, Mexico COFEPRIS and the headquarters also passed the GMP on-site inspection of Korea MFDS; it owns GMP certificate or EIR issued by European, US FDA, CFDA and other countries.
GMP Inspection History
API Registration Information