With ICH Q7 as the guidance and QA Dept as the Center, Zhejiang Shenzhou Pharmaceutical Co., Ltd. has established a perfect quality assurance system and passed the GMP inspections performed by China SFDA, U.S. FDA, Korea FDA, EDQM and German LSJV, providing customers with high-quality, competitive and GMP-compliant products.
Company employees shall receive GMP training before performing their job and attend refreshing training periodically as per the written procedure in order to apply GMP production requirements in the production activities.
QC Dept is equipped with state-of-the-art analytical instrument and staffed with the well-trained analysts, which enable us to monitor the related substances, residual solvents and particle size distribution of the final products in order to guarantee the quality. We are capable to perform impurity study, assay testing, stability monitoring and development and validation of the analytical method by our own.
Drug Master File
Our products are mainly supplied to European and US markets. And we are one of the earliest China factories which obtained CEP certificates and we can compile drug master file for registration of our products in different regions by our own.