Environmental Monitoring Risk Assessment Service for a Leading Vaccine Enterprise Project Background

Project Background:

Leading rabies/influenza vaccine enterprise with extensive viral vaccine R&D/production experience and independent technologies. Within its QMS, strict environmental monitoring & risk assessment serve as the lifeline for sterile product safety, efficacy and compliance.

AUSTAR's Solution：

• Environmental monitoring risk assessment for rabies vaccine bulk and formulation workshops

• Risk identification

• Risk control strategy formulation

• Environmental monitoring sampling point confirmation

• Risk assessment report compilation

AUSTAR's Value & Client Benefits：

• Integrates QRM with CCS as a foundational practical application beyond technical services

• The team synergizes with the client's resources to deliver high-quality assessment efficiently

• Aligns with latest EU GMP Annex 1, helping the client upgrade the environmental monitoring management system effectively