Quality & Compliance

EHP Quality Management consists of Quality Assurance, Quality Control and Regulatory Affair. EHP Qaulity System has been established based on Esteve Quimica’s Global Quality Framework and Quality Policy.

EHP advocates quality culture: Quality is the life of an enterprise; Quality first, Service first.

EHP Commits to the highest quality standards of pharmaceutical industry, including cGMP standards as well as latest industry trends. 

EHP Commits to the best customer service, the proactive and flexible service to meet the customers’ needs.

 

EHP has been regularly inspected by Heathy Authorities (FDA, European Authorities, PMDA, MFDS, NMPA...). 3 successful US FDA inspections have been received in 2012, 2015 and 2019.

 

Milestone

-          First Process Validation, 2009

-          First API Validation, 2010

-          First US DMF Filing, 2010

-          European Agency(AEMPS) Inspection, May 2011

-          FDA Inspection, Jan 2012

-          Empower3 CDS Go-live, Mar 2013

-          2nd FDA Inspection, Mar 2015

-          MFDS Inspection, Jun 2017

-          LIMS System Go-live, Jul 2017

-          JDE System Go-live, Jan 2018

-          PMDA Inspection, Jun2018

-          TrackWise Go-live, Sep 2018

-          3rd FDA Inspection, Jan 2019

-          EMA (HPRA&AIFA) Inspection, Jul 2019





 

Contact USmore

Esteve Huayi Pharmaceutical Co.,Ltd.

Tel : +86 575 89105000(operator)
Fax : +86 575 88225266
Email : ehp@estevehuayi.com
Website : www.estevehuayi.com
Add : Linhai Rd. 30, Shaoxing Paojiang Industrial Zone,Shaoxing, 312071 Zhejiang, China

SALES :

Tel : +86 575 89105808
Fax : +86 575 88225266
Email : chxu@estevehuayi.com


PURCHASING :

Tel : +86 575 88225268
Fax : +86 575 88225266
Email : purchase@estevehuayi.com


HR :

Tel : +86 575 89105258
Email : hr@estevehuayi.com