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-Manufacturing Site Profile-
located on National Economic Industrial Park (10,0000 sq.m. occupied) Chengdu, China.
Mainly focusing on developing and manufacturing injectable drugs.
Designed by M+W Zander to meet the most stringent GMP standards of EU, US and China, including Workshops for oncology injectable solids (13,000 m2), R&D and QC labs (4,000 m2), Warehouse and utility buildings (6,000 m2), Admin building and dormitory (9,000 m2), Land for future expansion.
-Production Capability and Capacity-
We have 2 workshops with MHRA Authentication.
Production capacity: 30 million vials per year for widely variable filling volumes from 2ml to 100ml.
Workshop I:
- Oncology injectable, 2 ml to 100 ml (Injection & Powder for injection)
- 300 vial/min, 300 L tank, 14 m2 Lyophilizor expandable to 42 m2.
Workshop M:
- Non-oncology injectable, 2 ml to 100 ml, 120 vial/min, 300 L tank.
Workshop P,
- Packaging line, Sheathing is available
- Innovative “Onco-Safe” coatings to increase the risk from clinical operation.
-Facility & Equipment-
Designed by M+W Zander to meet the most stringent GMP standards of EU, US and China:
Water System
State-of-art water system from Finn-Aqua & Steris
- Generation & distribution of PW and WFI is fully automated
- Class one reverse osmosis membranes, EDI
- Online TOC ,PH, Electrical conductivity on inspection system
Compounding System
- State-of-art compounding system employed
- Full closed system for API dispensing
- RTP charging system to compounding vessel
- Two-stage sterile filtration with on-line integrity testing
- CIP & SIP employed
Filling Line & Isolator
Integrated Filling Line with Isolator technology from Steriline (Italy)
- Integrated Washer / depyrogenation / Filler /Stoppering / Capping line
- Online particle and airborne micro-organism monitoring system
- Integrated Isolator with CIP / SIP (VHP sanitizing)
Automated Lyophiliser
Automated loading&unloading system for lyophiliser from SRK (Germany)
- Automated loading & unloading system inside isolator
- Lyophilizer with automated inspection and leak test, CIP/SIP
- Protect product from personnel impact and cross-contamination
- Provide operators with safety and effective protection
-Quality System Overview-
Quality Policy
- Concentrate on improving global user ‘s health
- Highest standards of ChP, EP and USP
- Comply with CHINA GMP (approved), EU GMP (approved) and FDA cGMP (planning)
- Establish a stringent quality management system according the cGMP is a critical factor to ensure the regulation compliance and quality of product.
-Quality Control-
- Good Laboratory Practice /Qualified QC Team Advanced Instruments and Equipment.
- Internal Control Standards: Be compliant with Control Standards of CFDA/EU/FDA-cGMP.
- Stability Experimental Facilities for which are in according with ICH Zone I, II & IV.
- A Complete Data and Sample management system.
Microbiology / sterility Test Isolator
*HPLC
*Stability Chambers
- Types of projects undertaken-
Contract manufacturing service for Oncology Injectable drugs.
-History of compliance certification-
MHRA approval in April 2014,
Chinese GMP approval in Oct. 2014,
FDA inspection planned