The establishment and operation of quality management system in Zhejiang Langhua Pharmaceutical Co., LTD is in accordance with the following regulatory guidelines:

The drug administration law of the PRC

Implementing regulations of the drug administration law of PRC

GMP for medicinal products for veterinary use

GMP 2010

ICH Q7

EU GMP Volume 4 Part II

WHO TRS 957 Annex 2

PIC/S PE 009-12 GMP Guide Part II

A thorough and comprehensive quality management system has been established in Zhejiang Langhua Pharmaceutical Co., LTD., and the system established can effectively supervise and control the whole process of quality management activities, such as supplier selection, raw material purchasing, sampling and testing, production, distribution and marketing, etc., the system is managed and improved through self-inspection and management review activities.

The training of personnel is conducted regularly by qualified individuals in the light of GMP and internal SOPs to ensure that the principles of GMP are carried out at all levels throughout our company.