Ensure High Quality
International Advanced Quality Management System
In terms of quality management, Fosun Wanbang Pharma Group 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 sterile injection production line located at the production site at Yangshan Road in Xuzhou, has passed on-site inspections by the EU EMA and the US FDA, and the oral solid dosage form workshop has also passed on-site inspections by the US FDA. The soft cream workshop located at the production site in Baoshan, Shanghai, has passed the GMP inspection from the Philippine FDA. A total of three member enterprise laboratories within the group have passed the CNAS certification.
Advanced Workshop and Equipment
In terms of manufacturing, Fosun Wanbang Pharma Group 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
Fosun Wanbang Pharma Group 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.
Fosun Wanbang Pharma Group 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
Specialized, flexible and large-scale international advanced pharmaceutical production site
Fosun Pharma (Xuzhou) implements the centralized and base-oriented strategy of Fosun Pharma Group, and strives to build an internationally advanced, specialized, flexible and large-scale pharmaceutical production site. The solid dosage form production line meets the requirements of wet granulation process, dry granulation process, top spray granulation, bottom spray coating, high-speed tablet compressing / double-layer tablet compressing, efficient coating, aluminum-aluminum / aluminum-plastic blister packaging . The BFS production line is equipped with a complex formulation compounding system, capable of preparing sterile suspensions, emulsions and solutions; it is suitable for the production of eye drops, inhalants and injections. The single-dose and multi-dose nasal spray production line can meet the production needs of different dosage form combinations of pharmaceuticals and devices with different filling volumes. The high-potency solid preparation production line is suitable for high-potency solid preparation for both the Group and external clients. The workshop is equipped with processes including explosion-proof spray drying, explosion-proof wet granulation, dry granulation, and explosion-proof coating. The entire line is designed in a fully closed manner, and it is capable of producing formulations such as tablets and capsules. With flexible batch sizes, the line not only supports the production of pilot-scale and clinical samples, but also meet the demands of commercial-scale manufacturing.
Rommelag Blow-Fill-Seal (BFS) EquipmentPSD-1
PSD-1 Spray dryer
Fette compressing machine
Glatt granulation and coating line
Uhlmann BEC700 Blister Packaging Line
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
2021.05
US FDA Site Inspection
Vial workshop inspected by USFDA
2023.08
US FDA Site Inspection
Full GMP Inspection& OSD PAI Inspection
2024.03
EU Site Inspection
Production Line of Sterile Lyophilized Preparations