Ensure High Quality
International Advanced Quality Management System
In terms of quality management, Wanbang Biopharma always adheres to the quality policy of " Quality First, Customer Priority, Comprehensive Management, Continuous Improvement", actively understands and implements China GMP, EU GMP, US cGMP and related appendices, and fully refers to ICH, WHO, PIC/S and various guidelines, continuously improve the quality management system, and promote the company's quality system in line with international standards.
At present, the freeze-dried powder injection production line has passed the EU GMP inspection, and the oral solid preparation production line has passed the US FDA GMP inspection.
Advanced Workshop and Equipment
In terms of manufacturing, Wanbang Biopharma invests nearly 600 million RMB to design and build a biological product workshop and a pharmaceutical preparation plant in accordance with international cGMP standards with EU and US pharmaceutical management concepts. Its key production and inspection equipment are relatively advanced imported equipment. Among them, the small-volume injection and lyophilized powder injection production line in the combined preparation plant uses the German B+S O-RABS system. The lyophilizer and automatic loading and unloading systems are domestic leading equipment.
B + S Production Line
Capsule Machine
Advanced Analytical Instrument
Wanbang Biopharma QC processes high-performance liquid chromatography, gas chromatograph, total organic carbon detector, UV-visible spectrophotometer, 1/10,000 balance, 1/100,000 balance equal precision instruments, all of which are internationally leading equipments that can meet the needs of various inspections. The sterility test follows ISOLATOR technology from Getinge-la Calhene, France. At the same time, instrument management procedures and verification procedures have been established. There are relevant operating procedures and use / maintenance records for each instrument, and a dedicated precision instrument room has been set up, ensuring that the instruments are effective and reliable in the state of qualification or calibration.
Wanbang Biopharma has established a series of approved specifications, analytical procedures and batch analysis records in accordance with statutory standards, and is equipped with necessary reference books such as pharmacopoeia, standard spectrums, related reference materials or reference standards for the test of API, excipients, materials, packaging materials, intermediate products, bulk products to be packaged, finished products, and stability test samples.
Stability Testing Chamber
Sterile Isolators
International Certification
2011.08
INVIMA Certification
Recombinant Human Erythropoietin for Injection
、
Pemetrexed Disodium for Injection
、
Production Line
2014.08
INVIMA Recertification
Recombinant Human Erythropoietin for Injection
、
Pemetrexed Disodium for Injection
、
Production Line
2015.07
Kenya Ministry of Health GMP Certification
Azithromycin Dispersible Tablets Production Line
、
Glimepiride Tablets Production Line
2015.11
PIC/S Certification (Malaysia Food and Drug Administration)
Pemetrexed Disodium for Injection Production Line
2016.06
US FDA Site Inspection
Crude Heparin Sodium Production Line
2017.11
Nigerian Ministry of Health GMP Certification
Glimepiride Tablets Production Line
2019.01
EU Site Inspection
Sterile Lyophilized Preparation Production Line
2019.05
US FDA Site Inspection
Oral Solid Dosage Form Production Line
2019.05
Peru Site Inspection
Non-final Sterilization Small Volume Sterile Injection Workshop