Quality assurance system
1, Quality standard
Our standards are in accordance with the Chinese pharmacopoeia 2000(volume 2); moreover, we made relative internal standards.
2, Quality assurance system
(1) According to the standards of GB/T19002-ISO9002, we established the quality system in our company in July, 1999, and became a GB/T19002-ISO9002 approved company in May, 2000.
(2) We made our quality policy, quality goal and quality target in the short time.
(3) According to the standards of GB/T19002-ISO9002, we made relative quality manuals, program files and management files.
(4) Our established a well-operated quality inspection supervision working system . The central testing laboratory in the quality supervision department is in charge of the inspection of materials, auxiliaries and finished products completely. It plays a very important role in our QA system.
3, The brief introduction of quality management organization
(1) Quality department is not affiliated with the production department
(2)The leader's name:Pan Huihui Title:section manager of quality supervision department(college, pharmacist)
(3) The number of quality supervisors:11 persons
(4)The quality of supervisors: pharmacology major, with the educational background of technical secondary school at least.
4, The brief introduction of inspection facilities
Main instruments:Engler viscosimeter, moisture quick determination tester, analytical balance, box-type resistance furnace, intellectual disintegration tester, freeze power tester, precise pH meter, dissolution tester.
5, The catalogue of quality management documents
(1) Company internal standard
(2) Industrial water inspection standard
(3)sampling method
(4) checking routine of materials and auxiliaries
(5)checking routine of finished product
(6) Product quality responsibility system
(7)Product quality file system
(8)Product quality analysis system
(9)Quality accident report system
(10)Product quality file sample and watch system
(11)Quality statistics report system
(12)Customer visiting system
(13) Management system of standards liquid for inspection and test organism
(14) system Program of quality plan compilation
(15) Program of inspection and experiment equipment control
(16) Program of inspection, measurement and experiment equipment control
(17) system Program of inspection and experiment state control
(18) Program of unqualified product control
(19) Program of correction and preventation facilities