中文

With in-depth understanding and interpretation of the requirements of Compilation of Global Data Integrity and Regulations Guidance, AUSTAR provides clients with appropriate compliance application solutions covering the field of human drugs, animal health care, medical instruments combination, medical devices, packaging materials, cosmetics, dietary supplements and food additives.Focus on pharmaceutical fields - antibodies, cell and gene therapy, ADC coupled drugs, vaccines, blood products, sterile preparations, API, oral preparations and Traditional Chinese Medicine, etc.

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Drug Quality Compliance

AUSTAR’s capability in drug quality compliance can effectively guide pharmaceutical industry to build an excellent and robust drug quality compliance system which ensures competitive drug quality.

GxP life cycle development supports drug research & development, clinical research, technology transfer, commercial production, distribution, market monitoring, and CRO/CDMO etc., meeting the requirements for GxP compliance and helps pharmaceutical enterprise fully grasp the concept of the pharmaceutical quality system and data integrity and the system mode of thinking, lead enterprises grasp the core elements of drug life cycle, take root in all-round quality concept including quality culture shaping, quality metrics program setting, data integrity assurance, knowledge management, quality risk management and quality management etc., accomplish continuous improvement and upgrading of the pharmaceutical quality system.

Process and Manufacturing Facility Validation Compliance

AUSTAR provides clients with compliance solutions for process and manufacturing facility validation & validation testing technology that cover the full life cycle of drugs. With professional technical capability in design, construction, installation, calibration and maintenance of plants, facilities, systems and equipment required for pharmaceutical project construction.

Process and manufacturing facilities validation compliance is based on AUSTAR’s understanding of product and technical process to meet clients’ demands for design, risk assessment, commissioning, verification, validation, and requalification/re-validation, process validation and continuous validation activities at different stages, helps projects conform to the FDA, EMA, MHRA, PIC/S, NMPA and PMDA GMP and WHO pre-qualification requirements.

Engineering Quality Compliance

Engineering quality compliance service can effectively link engineering quality with drug quality compliance. The ability covers the whole process of the project, from feasibility study, demands, design, construction, commissioning & qualification, delivery, operation and continuous improvement and decommissioning. Establishing connection with project management knowledge system of pharmaceutical industry, covering good engineering practice tools, methods and standards to ensure compliance.