Quality Systems Management
Since the establishment of JSBio, we have been loyal in our pursuit to offer “Quality First” as our highest priority of business. Our Quality Assurance team oversees raw materials management, production, warehouse, shipping, and logistics matters. To ensure our clients receive reliable, consistent, and high-quality products, JSBio adheres to the strict guidelines expected within the industry, as well as our own high standards regarding business operations. JSBio has been approved and recognized by global and domestic agencies. We also received ISO9001, ISO14001, and ISO13485 certifications; as well as completed certification requirements for a Cell Culture Medium Class I Medical Devices from NMPA in 2015. More recently, some of our products have been submitted for DMF with the US FDA to include production facility, production processing, packaging, and product storage approval which will be used to support drug IND and NDA filings.
Staff Training/Education Assistance Programs
Professional training of staff to ensure quality performance
On-site training/education for employees pursuing MS and PhD programs related to this industry
Raw Materials Management
At least two qualified suppliers for each raw material
Use of raw materials that meet the standards of multinational pharmacopeias such as China, the US, and the European Union to ensures high purity and consistency of products
Strict supplier selection and management system
Stringent inspection of raw material storage
Manufacturing Management
Development of cGMP compliant SMPs and SOPs
Full documentation training, comprehension assessment, and routine testing
Monitoring of our facility’s impact on the environment
Specification of In-process Control and release
Management of manufacturing at our Nantong facility (2022), in addition to our Lanzhou facility (2011)
Strict confidentiality measures for client formulations
Adoption of an Intelligent equipment initiative aimed to reach an Industrial Intelligence of 4.0
Warehouse
CCM1 in Lanzhou: >2000m2 for raw materials; 240m2 Cold storage
CCM2 in Nantong: automation tridimensional storehouse, Over 600 m2 for raw materials(>1500 Storage Bin); Over 450 m2 Cold storage (>1500 Storage Bin); Temperature and humidity control
Warehouse administrative offices for the facility
Logistics
Choosing the best shipping package and delivery methods according to individual product requirements
Communicating closely with logistics partners to ensure transportation routes and statuses meet the client’s expectations
Scientific Quality System
Related Quality Certifications
ISO13485: Medical device quality management system Certificate
ISO14001:2015 Environmental Management System Certificate
ISO9001:2015 Quality management system Certificate
Class I Medical Device Production Filing Certificate
ISO 45001 Occupational health and safety management system Certificate
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