Laboratory and office area
Furmonertinib Mesilate Tablet workshop and warehouse
Reserved construction land for workshop
Plan for laboratory and office
Business Scope
- As an innovative pharmaceutical industrialization base, Jiangsu Allist mainly undertakes the commercial production of Furmonertinib Mesilate Tablet with an annual production capacity of 100 million tablets at present.
- Conduct the production of clinical samples and pilot-scale research in the new drug research and development phase.
- Jiangsu Allist has 17,000 square meters of production workshop and laboratory, advanced equipment and facilities, all the key production equipment and testing instruments are international first-class brands.
- The design concept of multiple varieties, small batch size and high added value has been applied to antitumor solid dosage form workshop.Various granulation processes include wet granulation, dry granulation, one-step granulation, extrusion-spheronization etc. Two dosage forms: tablet and capsule. Multiple packaging such as Aluminum-Plastic, Aluminum-Aluminum and bottling-packaging.
- Base on the perfect quality system and operation management, Jiangsu Allist has successfully not only passed the new drug registration on-site inspection and GMP Compliance Inspection but also passed overseas customer audit for many times.
Quality System
- Document System: 19 categories and over 700 documents, including Organization and Personnel, Equipment and Plant Facilities, Qualification and Validation, Production Management, Quality Management, Raw Materials and Drug Product, Computerized System etc.
- Self-Inspection: Strictly Self-Inspection management (at least once a year), practical execution plan, actively invite professional institutions and experts for simulation inspection from time to time.
QC Laboratory
- Set up a standardized QC laboratory in accordance with GMP requirements. All key instruments are international first-line brands and under network edition management.
- Computerized system validation has been completed for all key instruments.
- All analysts have been trained in GMP and analyze operational skills.
- Standardized laboratory management and operation.
Pollution Prevention and Control in Production Process
- Pay attention to environmental protection，occupational health and safety in the production process
- Use closed feeding special interface
- Closed transfer of dedicated PE bags to minimize the contamination and cross contamination in production process