Preparation C&Q Compliance Consulting Service for A Leading Pharma Firm in China-US-EU Markets

Project Background：

A leading pharmaceutical company with two modern production bases, strong R&D capabilities, and efficient technology commercialization. It maintains long-term industry-academy-research collaborations with over ten renowned institutions. The client focuses on international R&D, with core advantages in gastroenterology, anti-infectives, and geriatric medicines. Its preparation sales network covers China, while API products are exported to multiple countries and regions. The client's newly built dosage form production line requires consulting and enhancement services in the field of qualification and validation.

AUSTAR Solution：

• C&Q Pre-consulting: Validation Master Plan (VMP), System Impact Assessment (SIA)

• Facility & Equipment Qualification & Validation

• Process/Method Validation

• CCS (Contamination Control Strategy)

• Airflow Visualization Studies

• GMP Training

AUSTAR Value & Client Benefits：

• Ensures compliance of the client’s quality management system and new production line with China-US-EU GMP requirements, initially achieving China GMP, followed by FDA cGMP pass.

• Through high-quality design and airflow studies, AUSTAR helped the client meet the latest EU GMP Annex 1 requirements for sterile operations, ensuring regulatory compliance and product safety in sterile manufacturing.