-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