质量体系

Quality System

The Quality System is managed in five aspects: Staff, Machine, Material, Method and Environment:

Personnel

The QC department has 36 persons in total, including 20 persons have bachelor degrees or above, 7 licensed pharmacists, 13 QA engineers and 11 assistant engineers. The average QC working experience of our team is 13 years. The inspectors participate in various kinds of drug testing professional knowledge training every year regularly or irregularly. The company conducts relevant training each week involving GMP knowledge, post operation instructions and other continuing education training, and all staffs will not operate in production line until passing the examination.

Machine: Inspection Instruments

The company has more than 100 inspection equipments in total, including three Waters HPLC; four Agilent HPLC; two Agilent GC; one Thermo IR; two Thermo AAS; one Agilent automatic dissolution device; one SUTAX automatic dissolution device; one Mettler Balance(0.001mg); four Mettler Balances(0.01mg); two Shimadzu UV-vis. The precision and sensitivity of these imported inspection instruments ensure the accuracy of our inspection procedure.

Material: Test-used Reference Materials, Chemical Reagents

The chemical reagents used for testing are sourced from reliable qualified and evaluated suppliers which could guarantee stable supply. The chemical reagents are separately placed and managed according to Chemical Reagent Management Regulations, Regulations for Management of Precursor Chemicals, Regulations for  Management of Toxic Reagent, etc., and the test liquids are managed according to Testing Fluid Management Regulations. The reference materials used in the test come from National Institute for Pharmaceutical and Biological Products Control. The reference material and standard material are managed according to Standard Substance Management Regulations and Management Regulation For Work Reference Substance. The culture medium is managed according to Medium Management Regulations. Test organism is managed according to Management Regulations For Test Organism.

Method: Statutory National Drug Standards, or Inspection Standards and Operating Procedures

The quality control laboratory will inspect each variety, each batch and each inspection item in accordance with the statutory national drug inspection standard operating procedures to ensure each variety, each batch and each inspection item meet the statutory national drug standards. In addition, for each variety, we have established internal release standards which are higher and stricter than the national drug standards. Furthermore, the finished products will not be allowed to release until each inspection item meets the release standard.

Environment

According to the requirements of GMP and the company's production, it is divided into four parts, namely material inspection, product inspection, microbial limit inspection and penicillin test. The material inspection includes incoming materials, auxiliary materials and packaging materials; product inspection includes inspection of intermediate products, products to be packaged, and finished products; microbial limit inspection mainly aims to check microbial limit of finished products and environmental monitoring of clean area; penicillin test is specific to inspect penicillin such as amoxicillin capsules, including the inspection of incoming raw materials, the intermediate products produced in the workshop, the inspection of the products to be packaged, and all inspection items of the finished products. The finished product inspection includes high performance liquid chromatography room, infrared spectrophotometer chamber, balance chamber, ultraviolet spectrophotometer chamber, physical and chemical operation room, basic instrument room, and microbial limit examination room.

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