Quality Guarantee System
The quality management are completed by QA and QC.
First, QA responsibility:
1 Carride out strictly the relative rules as Medical Management Law and so on.
2 Build quality guarantee system and supervision.
3 In charge of the supervision of all the quality activities and to make sure all the products can pass GMP standard.
4 Build enterprise’s GMP files system.
5 Draw up the responsibilities of the employees and so on.
6 Protocol the GMP training plan of the employees and the training of QA employees.
7 Build customers’ quality files.
8 Promote the GMP.
9 The samples of materials, water, inter products and ready made products.
10 Build the environment supervision plan.
11 Check the original records.
12 Check the numbers, test records of the ready made products.
13 The evaluation, policy of the main materials suppliers.
14 Recheck of the characters and others of the printings.
15 The treatment to the differences of the materials and so on.
16 Treatment to the feedbacks.
17 The treatment of quality complains, and so on.
18 Organizing and coordinating the work of the verification and so on.
19 In charge of the relative laws and GMP requirements.
20 In charge of the all the preparation of GMP certifications.
21 Quality analysis.
22 Treatment of quality faults.
23 Collect the information of the market and so on.
24 Visit the customers.
25 Report the unqualified medicines
26 Learn the visit of the medical supervision departments.
27 Bring all the relations between all the department in to line.
28 Others works
Second, QC responsibilities
1 Draw up the samples principles fo materials, inter products and so on.
2 Draw up the management rules and operating rules of the test equipments and so on.
3 Check the medicals and production standard.
4 Draw up the responsibilities of the employees and the quality standard.
5 Check the stabilities of materials and inter products and so on.
6 Test the input materials, inter products and so on.
7 Test the industrial water, dust numbers and microbiology numbers.
8 Test the samples.
9 Test of the raw materials, supplement materials and so on.
10 Collect information.
11 Maintain of the equipments
12 Test of the supervision equipments and so on.
13 Professional theory and skills assessment test of the supervision employees and so on.
14 Accept the guidance of drug control department.
15 And other works.
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Thank you for visiting the official website of Quanxingxiangsheng. If you have any cooperation intention or suggestions, please contact us through the following ways, and we will reply as soon as possible. Thank you!
Address：No.8,Industrial Avenue,Wanzhou city,Chongqing,China.
Tel / Fax：+86-023-58365266 58365666
Email：
Export contact email：info@xsbiopharm.com
Quality contact email：quality@qxxsbiopharm.com
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