We have established a comprehensive Quality Assurance (QA) system for GMP manufacturing. The QA system is based on the requirements of appropriate regulatory guidelines including FDA 21 CFR Parts 210, 211, 600, and 610, as well as EU's GMP Directives and Guidelines. By adhering and constantly improving on the various aspects of the QA system, we ensure its ability to provide customers with the highest level of assurance and satisfaction.

Key components of the QA system are:

Documentation
The comprehensive documentation system, comprising of Quality Manuals, SOPs, Work Instructions, and Data Collection Documents, guarantees that all documents are correctly registered, indexed, and maintained.

Training
We have a comprehensive GMP training programme which ensures that staff members are trained to perform GMP activities competently.

Regulatory Compliance
We constantly monitor regulatory developments in FDA, EMEA and ICH to ensure relevant requirements are updated and implemented.  Our Type V DMF is listed at FDA.

Audits
Internal audits are implemented to ensure GMP compliant biopharmaceuticals are manufactured to approved procedures. External audits are conducted to approve vendors / laboratories to supply materials, equipment or services to us and can be arranged at the request of partners.