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Quality system
 
The production practice is managed in strict compliance with cGMP requirements, and we are going on a well-established document system and quality control system.
  • The quality control network of CPRI is led by general manager and directed by quality director. QA unit is responsible for organizing the quality control routine duties.
  • CPRI carries out strictly cGMPs and GMP management in an all-round way, and now we have established and keep on improving the rigid quality control system.
  • CPRI sticks to introduce scientific management and technology advancement into the production practice and rigorously carries out SOP.
  • Some advanced instruments made in USA, such as HPLC, GC, IR and other quality control instruments are applied in supervising and controlling the whole process of manufacturing to ensure that the products comply with quality specifications.
Responsibilities of Quality Assure Unit
  • Releasing or rejecting all APIs
  • Reviewing completed batch production and laboratory control records
  • Make sure that critical deviations are investigated and resolved
  • Approving Specifications and master production instructions
  • Approving procedures affecting the quality of APIs
  • Performing the internal audits
  • Approving changes affecting API quality
  • Investigating and resolving quality-related complaints
  • Performing product quality reviews
Responsibilities of Quality Control Unit
  • Releasing or rejecting all raw materials, packaging, labeling materials, container, closures, in process materials, and finished product, making sure that material are appropriately tested and the results are reported
  • Releasing and rejecting procedures and/or specifications and any change to a spec., method, process or procedure.
  • Reviewing production records to determine errors and ensuring that investigations have been conducted and corrective action taken.
Responsibilities of Expert Panel for Validation
  • Reviewing and approving validation protocols and reports
  • Making sure that effective systems are used for maintaining and calibrating critical equipment
Documentation
  • For Iron Sucrose, we have established the document system in accordance with Q7a and cGMP, and the system will continue to be improved during the production practice.
Training
  • Training is regularly conducted by qualified personnel.
  • Examination will be hold after training.

 
 
Tel:8623-62513495 62505976 Fax:8623-62512066
No.565,Tushan Rd.,Nan'an District,Chongqing,PRC
 
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