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Hunan Steroidchem pharmaceutical Co., Ltd. has established its own strong QA and QC team, they are controlling and guarantee the quality of all our materials, which are produced under GMP conditions.

Quality Control (Q.C.)

We have the area for Q.C of about 500sqm, equipped with the newest instruments, including:
 
· 6 sets of HPLC
· 2 sets of GC with head space
· 2 sets of Chambers for Stability test
· Medicine dissolution test meter
· UV spectrophotometer
· Polarimeter
· Particle size analyzer
·  …..

The main functions of our Q.C. department are:

· Testing and approval of raw materials
· Testing and approval of all the intermediates and final API for export
· Monitoring of manufacturing process
· Implementation of GMP 
· Documentation of technical information(DMF,EDMF,Technical package, etc.) 
    
 
Quality assurance (Q A)

Hunan Steroidchem pharmaceutical Co., Ltd. has been developing and producing high quality products under stric GMP conditions. Quality control and quality assurance are given high priority in order to meet international pharmacopoeia specifications and special customer’s requirements.
· Method of Analysis for testing our materials are validated to give the re-producible results
· All the analytical test procedures and manufacturing procedures are well documented and revision is undertaken as per specified protocol.
· Trend analysis of purified water and final products are maintained.
· Stability study is a very important area of quality assuance.
    
Hunan Steroidchem pharmaceutical Co., Ltd. continuously improves the quality management through the implement of a complete, advanced, scientific quality management system according to current GMP, national and international standards. We guarantee that each product will be manufactured under strict controls, which consistently meet present standards of safety, efficacy, quality and purity. Quality is a conscious commitment and a permanent goal to match the high expectation of our customers. Excellence in quality systems will be achieved through the team effort with trained personnel. Quality is the responsibility of all persons involved in manufacturing.

We always follow that quality is the life of the company.

            

 
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