It is a global biopharmaceutical company with a focus on oncology, autoimmune diseases, and ophthalmic diseases. The company plans to build a new plant to increase its capacity in Shanghai that complies with Chinese GMP, FDA cGMP, EU GMP, and WHO GMP. The product type of the plant is monoclonal antibody (mAb). AUSTAR Compliance Consulting Services is honored to be chosen as its validation service provider.
AUSTAR Compliance Consulting Services is to offer commissioning and qualification services for its HVAC, clean room, Utility system, warehouse, temperature control and sterilization equipment, and upgrade its current SOPs regarding validation, so as to ensure that the qualification and validation can meet the requirements and provisions stated by NMPA, USA FDA and EU EMA.
With rich cases and experiences, AUSTAR Compliance Consulting Services has already developed qualification and validation into a mature service years ago. AUSTAR compliance consulting service team will be working closely with the client's project team to drive the implementation of the project with regulatory compliance, validation, and project management capabilities.