Quality Assurance
Pharmaron’s biologics CDMO quality assurance team supports cGMP-related product development and manufacturing operations. Quality, trust and data integrity define our approach with every aspect of cGMP drug product development and manufacturing. We are committed to providing high-quality, safe and effective products and services.
- Quality oversight of cGMP operations, from materials, production to final product release
- Perform cGMP supplier audit and qualification, cGMP training and documentation management, deviation and change control assessment, qualification and validation lifecycle management
- Conduct internal audits to ensure appropriate cGMP and compliance status are maintained throughout product development and cGMP manufacturing lifecycle
- Audit support for clients and assistance with site inspections
- Internal support to project teams and ongoing training programs for all cGMP employees to ensure policies and SOPs are appropriately implemented
Capabilities
Quality Management System (QMS)
- QMS follows ICH Quality Guidelines and in alignment with current cGMP and global regulatory requirements adopted by the US FDA, NMPA, MHRA and EMA
- Quality Manual and Policy, SOPs and Records/Forms form 3-tiered document structure hierarchy
- E-system TrackWise is implemented to enhance the effectiveness of QMS during the execution
