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GMP certified factory and advanced facility

The factory designed and constructed in strict accordance with GMP standards, has rational layout, distinct classifications, proper production process which is free from intercross between personnel flow and material flow, which guarantee the product quality. The key equipments are all state-of-the-art products imported from abroad with high automaticity and stable operation functions. The facilities are validated strictly according to the GMP requirements annually, which enhance the assurance of the product quality. All the production lines have passed SFDA GMP inspections.

High-quality staff and normative training

Staffs in key production position have technical background of pharmaceutical preparations or pharmacy subjects. They are skilled at sterile drugs production. They should receive training of technical skills and examination of theory and operations prior to the positions. The team leaders should have years of work experiences. Every year all production staff should receive examinations of GMP regulations and SOPs training periodically in order to update their knowledge and skills.

Perfect file system and strict management

Managing staff conduct the production control in strict compliance with the GMP requirements. This includes a post duty system and total control of key processes with statistical analysis. They also have the responsibilities of establishing perfect filing system that records process regulations, standard operating procedures and post duties. This makes all personnel behaviors  be recorded, monitored, traceable and ultimately standardized.

GMP Certificate (Small Volume Parenteral Solution) GMP Certificate (Lyophilized Powder for Injection) GMP Certificate (Bulk Drug workshop)

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