AUSTAR's Compliance and Validation Consulting Services for an Integrated Pharmaceutical Company

Sterile injectables are a clinically indispensable dosage form, delivering drugs directly into the bloodstream where even minor contamination carries severe risks. This necessitates stringent controls over environmental, equipment, and operational aspects in aseptic manufacturing facilities to ensure sterility and pyrogen-free products. Rigorous validation, encompassing equipment qualification, process validation, and aseptic processing standards, ensures consistent quality and stability. With broad therapeutic applications across oncology, cardiovascular, and neurological disorders, sterile injectables remain pivotal to patient care and will continue advancing global health outcomes.

Project Background:

Our client is an integrated pharmaceutical company with a core focus on biopharmaceuticals. Specializing in multiple therapeutic areas, it boasts a diverse product portfolio with notable achievements in oncology and neurological disorder treatments. The company has recently constructed a new lyophilized powder injection sterile workshop, equipped with state-of-the-art production facilities to ensure compliance with stringent Good Manufacturing Practice (GMP) requirements for lyophilized powder injection manufacturing and quality control.

AUSTAR Solution:

• Conducted a comprehensive GMP gap analysis for existing injectable production facilities, supporting warehouses, QC utility systems, and quality management systems (including validation systems),    covering both hardware and software to identify deviations from GMP standards and provide rectification recommendations.

• Software: Quality management system enhancement consulting and operational guidance.

• Hardware: GMP compliance consulting and validation support for rectification measures.

• Personnel competency: GMP-focused training programs.

• Mock inspections and on-site technical support for regulatory inspection readiness.

AUSTAR Value & Client Benefits:

• Led by AUSTAR's consulting team, the gap analysis identified discrepancies between the current status and NMPA GMP requirements, with prioritized recommendations for improvement based on risk assessment.

• Building on phase one findings, AUSTAR's team organized phase two GMP enhancement initiatives, assisting in organizational restructuring, quality system module development, and clarification of departmental responsibilities.

• Restructured the client's quality management documentation system, proposing a compliant yet practical file architecture through collaborative discussions.

• Elevated overall quality management capabilities by proactively identifying system weaknesses and implementing corrective actions, thereby strengthening the client's market competitiveness.