Quality
Ensuring Biologics Excellence with Comprehensive Quality Control and Assurance
At Pharmaron Biologics CDMO, quality is at the core of our mission. Our Quality Control (QC) capabilities are designed to exceed stringent regulatory requirements, ensuring product integrity and peace of mind for clients. By integrating advanced analytical testing, tailored stability management, and cGMP compliance, we guarantee precision and accuracy at every stage of biologics development.
Comprehensive Systems and Oversight
Our Quality Assurance (QA) and Quality Management System (QMS) frameworks combine vendor qualification, lifecycle oversight, and real-time monitoring to streamline compliance and ensure operational excellence. Designed to align with global regulatory guidelines, these systems enable seamless execution of even the most complex biologics programs.
Capabilities
Precision-Driven Quality Control (QC)
Pharmaron’s quality control ensures product integrity and compliance from early development to manufacturing.
- Comprehensive Analytical Testing: Assays for identity, potency, purity, and stability across diverse biologics, ensuring data-driven decision-making and compliance with ICH guidelines
- State-of-the-Art Technology: Advanced methodologies, including HPLC, CE, ELISA, and mass spectrometry, for unparalleled precision and reliability in product characterization
- Stability Program Management: Tailored stability studies to assess shelf-life, environmental impact, and long-term product viability
- cGMP Compliance: Continuous QC monitoring to meet evolving regulatory requirements.
Quality Assurance (QA): Safeguarding Compliance at Every Step
Our QA framework ensures Good Manufacturing Practices (GMP) compliance, guaranteeing biologics meet the highest global standards throughout their lifecycle.
- Vendor Qualification: Comprehensive supplier audits and qualification to ensure raw materials meet predefined standards
- Lifecycle Oversight: Real-time monitoring of quality from initial project design through scale-up and commercialization
- Internal Audits: Proactive GMP audits to ensure regulatory compliance, mitigate risks, and maintain alignment with global standards (FDA, EMA, NMPA, MHRA)
- Regulatory Support: Expert preparation for client and regulatory inspections, with a track record of success in facilitating approvals
- Training and Knowledge Transfer: Comprehensive GMP training programs for teams, ensuring policies and SOPs are consistently executed across operations
Quality Management System (QMS)
Pharmaron’s QMS integrates advanced tools and workflows to streamline compliance and efficiency, aligning with ICH, FDA, EMA, MHRA, and NMPA guidelines for seamless project execution.
- Document Control: A three-tiered hierarchy of policies, SOPs, and records ensures clarity and accessibility
- Digital Process Optimization: The TrackWise e-system enables real-time monitoring, deviation tracking, and CAPA (Corrective and Preventive Action) management to maintain operational excellence
- Continuous Improvement: Data-driven quality metrics and root-cause analysis drive proactive enhancements to processes
- Integrated Training Programs: Ongoing education ensures our teams are equipped with the latest regulatory and technical expertise
Partner with Pharmaron Biologics CDMO
Contact us to discuss your project needs and leverage our expertise in delivering compliant, high-quality biologics.
