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Company Profile General manager's Speech Eu cGMP Quality Management System Development Path Honor Style Contact Information
Along with our pharmaceutical industry
Production capacity and level of gradual improvement

Along with the gradual improvement of production capacity and level of Chinese pharmaceutical industry, it is essential for Chinese pharmaceutical enterprises to participate in international competition. However, according to EU regulations, marketing licenses for preparations are only issued to legitimate enterprises in the EU. To sell preparations to the EU market, foreign companies must set up local branches or through local partners. As a result, few Chinese pharmaceutical companies are able to sell their preparations to Europe.

 

Shenzhen Lijian Pharmaceutical in early June 2006 accepted the German medical Bureau EU GMP certification expert group for a week of on-site inspection, inspection process experts on the company's work to give a high evaluation.In July 2006, the company of the sterile powder injection, capsule, tablet, granules and dry suspension agent won the European GMP certification smoothly, also has obtained a series of products including cephalosporins rules to enter the European market permits, marks the state health pharmaceutical product quality and production management in shenzhen has reached the international advanced level, Become the first domestic non-terminal sterilization preparation through the EU GMP certification manufacturer.The first batch of cefuroxime sodium powder needles was exported to Germany in December 2006, marking the official entry of chemical preparations products of Chinese pharmaceutical enterprises into the world pharmaceutical mainstream market.

The overall standard of the EU GMP system is much higher
Domestic GMP requirements,Belong to the GMP standard of developed countries,
Mainly displays in:

1

Environmental control to prevent drug contamination is better than domestic GMP
More stringent requirements:
In addition to the static cleanliness standard is higher than the domestic GMP level 1, the dynamic dust particles are also clearly required.The types of bacteria to be monitored and the testing time for microbial contamination are much higher than those of domestic GMP.

2

Quality confirmation and verification requirements are more standardized and strict:
Eu GMP requires the verification of the methodology for the inspection of raw materials, intermediate products, finished products and cleaning residues, while domestic GMP has no requirement.Before verification of the media simulation packaging, process water and production process, are much higher than the domestic GMP requirements.

3

Quality assurance system according to EU GMP standard
More perfect:
The company has established more than 2000 bilingual documents in accordance with EU GMP, European Pharmacopoeia and relevant regulations, guiding every step of production and quality operation, and conducting dynamic environmental monitoring for each batch of products to ensure the controllability of production and quality control.The quality assurance system covers all fields related to product quality inside and outside the company, including starting materials, production process, quality control, release of finished products, and sales.The OOS (treatment beyond the qualified range) system, deviation treatment system and annual review OOT (treatment beyond the expected trend) system were established. Implement QP (licensor) quality system at the same time, the current domestic GMP has yet to establish these rules.In addition, the EU GMP certification is a dynamic certification, every year needs to regularly verify and confirm the production facilities, process, inspection methods, instruments and equipment. At the same time, the registration and verification of products are closely combined together.

4

In terms of hardware, all direct contact with the product
The material of the equipment has material proof
Install differential pressure display and differential pressure alarm before and after each filter; There is a fault alarm system.Production equipment and environment most in airtight operating system; Product quality parameters have instrument and equipment online printing function; Set up a buffer between warehouse and production area.The layout of the production environment with D, C, B, A step by step layout; The warehouse area has established an automatic monitoring system, and the monitoring points are distributed to different areas and different levels of the warehouse.