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At present, the quality department of the company is learning advanced concepts and technologies through foreign registration and application for foreign certification, introducing equipment and instruments from the world, formulating internal control quality standards higher than domestic or international enterprises, further strengthening the production process control and quality inspection of products, and achieving continuous improvement of quality management。
Management assurance
1、Attach great importance to measures to avoid pollution and cross contamination, and strive to minimize human errors。
The Quality Department shall check the factory facilities, equipment materials, process parameters, personnel training, site management, cleaning steps, verification and review, formulate efficient and stable management procedures and operating procedures, and implement them to reduce quality risks and improve product quality。
2、Perfect verification management and implementation system。
The company attaches great importance to verification, establishes a verification committee and a verification implementation team, systematically establishes a comprehensive verification system covering plant facilities, analytical instruments, equipment, inspection methods, production processes, cleaning methods, and materials, and runs the design (DQ), installation (IQ), operation (OQ), and performance (PQ) verification throughout the whole process from experimental design to small test, pilot scale up, and commercial production, Adhere to the principle that major changes without verification shall not be approved, and equipment, processes and methods without verification shall not be used to effectively ensure the stability of production and product quality。
Pay attention to the research of API quality standards to make them higher than EP, USP or JP, especially the validation of analytical methods. Fully implement the requirements of FDA's guidance on validation of analytical methods. The validation contents include the accuracy, precision (repeatability and intermediate precision), specificity, detection limit, quantitative limit, linearity, range and durability of analytical methods, to ensure the accuracy and reliability of inspection data, and the accuracy and reliability of API content, solvent residue The analysis and research of impurities have accumulated a lot of experience。
1. personnel
QC now has 14 full-time inspectors, all of whom have college or higher education in pharmacy or related majors, all of whom have inspection certificates for corresponding posts, and many of whom have obtained national licensed pharmacist qualification certificates。
2. field
It has a comprehensive testing center covering an area of more than 1000 square meters, including physical and chemical laboratories, precision instrument rooms, liquid phase analysis rooms, gas phase analysis rooms, microbial testing rooms, etc。
3.Analysis instrument
A large number of advanced analytical instruments are introduced to ensure that the test data are accurate and meet the requirements of international certification. The main analytical instruments include Agilent 6890N gas chromatograph, Aglient 1200 Series high performance liquid chromatograph; Dionex Summit HPLC; NICOLET 380 infrared spectrometer; AUTOPOL IV polarimeter; Lambda25 ultraviolet visible spectrophotometer; Metrohm787 KF moisture meter; Binder KBF240 stability test chamber; Milli-Q Academic ultrapure water meter; T50 Mettler potentiometric titrator and other foreign imported precision testing instruments。
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