QUALITY SYSTEM

ISO9001 – Hesperidin – Di’ao Chemistry

Chengdu Di’ao Chemistry of Plant Co., Ltd. has built a strict quality control system in accordance with ISO9001:2000 since the year of 2002. “Not just we get a paper, but all the staff operate under clear instructions’, said Mr.Mou Cheng Kun, the director of the company.

cGMP – Diosmin – Runde Pharmaceutical

As a manufacturer of APIs, food additives and dietary ingredients, Chengdu Runde Pharmaceutical Co., Ltd. has created GMP guidelines to follow the basic principles:
(1) Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
(2) Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary.
(3) Instructions and procedures are written in clear and unambiguous language
(4) Operators are trained to carry out and document procedures.
(5) Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented.
(6) Records of manufacture  that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
(7) The distribution of the drugs minimizes any risk to their quality.
(8) A system is available for recalling any batch of drug from sale or supply.
(9) Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.

Advanced Lab

Advanced lab is not only the final judge to decide if a certain batch of goods is qualified, the most important role is to inspect each step in whole processing. The company is proud of having an advanced lab in quality control system.

Documentation

DMF – Drug Master File
If you want to know more about our Diosmin DMF situation, please email quality@diosmine.com

COS – Certificate of Suitability
If you want to know more about our Diosmin COS situation, please email quality@diosmine.com

API Registration
If you want to know more about our Diosmin registration all over the world, please email quality@diosmine.com