Quality management philosophy：Quality by design(QbD)
Quality management system
Chemtrue’s quality management system is a total quality management system taking C-GMP as basis and ICHQ7 as guide,which is dominated by QA unit and all functional departments are involved in. The whole process, from product design, the choice of starting materials suppliers,product development, production process, product release to sales and product delivery,after-sales service,is managed and controlled based on strict quality standards requirements. We keep improving quality assurance system constantly to ensure the good product quality.
Quality assurance(QA) System
Quality audit: audit of raw material suppliers , to ensure qualified materials and stable supply chain. Accept customer audit to our site,to ensure our quality and running system meet customer requirements
Quality control: control production people, production equipments, raw materials,production process,workshop environment
Validation management: including cleaning validation, process validation, equipment validation, analytical method validation,etc.,
Quality control(QC) System
Chemtrue has established a all-sided quality control process.Based on the guideline of ICH and basis of C-GMP we have established our internal control standards management system.
QC people’s responsibility covers
1.the testing of raw materials,intermediates(including in-process control) and end products.
2. the development and validation of analytical methods
3.analytical instruments verification, cleaning verification,etc.,
Main testing items：purity and impurity,residual solvents,compound structure ID,ee%, moisture test, residue of ignition,loss on drying, etc.,
Main testing equipments
LC-MASS(Waters),GC-Headspace Sampler(Agilent),HPLC(Agilent,Shimadzu)，Moisture tester,etc.,
Analysis center display: