Quality assurance

“Focusing on details and achieving excellence” is what Senlan Bio pursuit.

From the selection of raw materials to the launch, the strict control applied in each link wins the high recognition for Senlan Bio from the authoritative organizations in the industry. The product of Senlan Bio has been certified by a number of international stringent quality system.

Implementing strictly the global raw material procurement standard

For raw materials, Senlan Bio implements the global procurement system, giving priority to the qualified well-known enterprises as suppliers. Senlan Bio has a set of supplier standards, selecting the raw materials strictly. Since the products are sold to the global market, Senlan Bio will conduct hazard analysis according to national pharmacopoeia, FCC and other international standards as well as the manufacturing process of raw materials, so as to establish the quality standard of raw materials.

Apply the clean workshop standard to standardize the manufacturing process

The factories of Semlan Bio are designed according to GMP clean workshop standard, the air cleanliness in the workshop is complied with international standard. Not only equipped with advanced manufacturing equipment, the factories of Senlan Bio are also with the continuously improving quality management system. The ambient temperature, humidity, airborne bacterial concentration and depositing bacterial in the manufacturing workshop have been monitoring by the Manufacturing Department continuously to ensure that all indicators meet industry standards. In addition, the factories are equipped with water purification system for manufacturing, and purified water can meet the requirements of both Chinese pharmacopoeia and American pharmacopoeia standards.

“Zero defect” is the aim of quality control

Senlan Bio has introduced international advanced testing instruments and equipment to ensure that the testing method is scientific and effective, as well as the product's active ingredients, purity, strength, composition and impurities limit meet the requirements. In addition to the advanced manufacturing and testing equipment, the company has also set up on-site quality supervisors to monitor every step of manufacturing, and to supervise the control process, every control point, control link and control step, and record them. The whole record must be checked by the quality authorized person with signature, and the certification for launch can only be issued for perfect product.