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Quality assurance



HEC Pharm always adheres to the concept of “Quality First” and has a well-established and reliable quality management system consisting of central quality assurance (CQA), manufacture quality assurance (MQA) and development quality assurance (DQA) to assure “quality controllability”
  
CQA functions overhead both Research and Development Center and HEC factories to coordinate efforts in both DQA and MQA by setting up a harmonized quality management system covering all HEC’s Pharmaceutical activities.


DQA basically functions in HEC Research and Development Center to guarantee a good developing practice and successful technology transfer from Research and Development Center to factory by building up a development management system to standardize all the development activities. HEC Research and Development Center has already established GLP-compliant animal laboratories, GCP-compliant bio-assay laboratories and GMP-compliant pilot plants for both drug substance (API) and drug products.


MQA separately functions at HEC’s four manufacturing bases to guarantee qualified medicinal products by strictly following international good manufacturing practice (GMP). HEC’s manufacturing bases were all accepted by CN CFDA, US FDA, EU (DE BfArM, SI JAZMP), WHO, AU TGU,KR KFDA and JP PMDA after GMP inspections.

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