Quality Management System  

qmsIntroduction to Jasun's QMS

In order to fulfill different requirement of customers, adpat to the emerging techlogies and meet the expectation of market to price, in the mean time, to produce qualified products, Jasun apply the ISO9001 Quality Manage System.
Which includes:

• Quality system
• Facilities and equipment system
• Process controlling system
• Packaging and labeling system
• Laboratory controls system
• Materials system
• Recording system

 

• Quality system

file_structureOur QMS integrates GMP requirement into ISO9001. Quality Manual is on the top followed by SOPs, technical guides and external documents. The documents are drafted, executed, amended and controled in line with the requirement of ISO9001.

 

• Packaging and labeling system

Differentiate raw materials, intermediates, and finish products with different color Strict batch numbering system.

 
 
Raw Material
Intermediates
Risk Material
Finish Material
 

Facilities and equipment system

Main equipments:   HPLC (5)   GC (6)  Digital balance (2) etc
Chemical Analysis
Preventive maintenance and regular validation of the equipment

 

• Purchasing Raw Material:warehouse

SOP  Purchasing and Receiving
SOP  Visual Inspection of Raw Materials,
SOP  Chemical Inspection of Raw Materials

• Warehouse and storage:
Enough lighting and ventilation
Strict labeling system
Designed quarantine area

• Releasing:
Design warehouse area for non-conforming products
Final checked and labeled by the QA before releasing.

 

• Processing controlling

Sophisticated SOPs and record forms to Guarantee the Accurate operation, traceability of intermediates and final finished products. Necessary actions have been taken to prevent cross contamination.

 

• Recording system

recordRecords have be established for

raw materials, intermediates, labeling, packaging materials, batch of production, laboratory data, including Certificates of Analysis and stability data, calibration, distribution, complaints and returns etc.