The Shanghai-based company has been chosen for a project for a global biopharmaceutical company, which has a focus on oncology, autoimmune diseases, and ophthalmic diseases
AUSTAR Compliance Consulting Service has won a service contract for a monoclonal antibody plant project.
The new project is for a global biopharmaceutical company, which has a focus on oncology, autoimmune diseases, and ophthalmic diseases.
The biopharma client plans to build a new plant in the area to increase its capacity in Shanghai that complies with Chinese GMP, FDA cGMP, EU GMP, and WHO GMP.
AUSTAR Compliance Consulting Services is providing commissioning and qualification services for the biopharma company's HVAC, cleanroom, utility system, warehouse, temperature control and sterilisation equipment, and upgrade its current SOPs regarding validation.
This is so as to ensure that the qualification and validation can meet the requirements and provisions stated by NMPA, USA FDA and EU EMA. With a rich experience history backing them, AUSTAR Compliance Consulting Services has already developed its qualification and validation into a mature service years ago.
The AUSTAR compliance consulting service team will also be working closely with the client’s project team to drive the implementation of the project with regulatory compliance, validation, and project management capabilities.