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We have individual QA unit and QC unit, according to GMP requirement under the guideline of ICH Q7. Our QC test center covers 1500m², including quality and chemical analytical lab, instrument analytical lab and microbial test lab. Many precious analytical instruments such as NMR, XRD, LC/MS, GC/MS, MALVERN Mastersizer2000, SEM, HPLC, and GC. etc are all well-equipped.

A complete documentation system for all kinds of SOPs is on site, and quality management regulations such as change control, deviation management, validation, calibration, self-inspection and quality review are strictly performed. From process design, material purchase, production, test and release to after-sale service, we practice overall process control, so as to ensure stable and high quality.

Our company accepts customer quality audits more than 50 times a year, and has been tested by national officials such as NMPA, US-FDA, PMDA, MFDS for on-site quality inspections for several times; up to now, we have successfully obtained a number of certificates including GMP, USFDA-EIR LETTER, CEP, EU-GMP and so on.