Biologics Quality Assurance

Biologics Quality Assurance

QA is responsible for MabPlex’s overall quality management. The main function of QA is to continuously enhance product and service quality, carry out the release of batches by Qualified Person (QP), and to strive for the highest customer satisfaction.

Capabilities

  • Bulk drug substance management
  • Cell bank and raw material release
  • QP Release of Investigational Medicinal Product (IMP)
  • GMP quality management and regulatory support (e.g. IND, IMPD, BLA)
  • Quality agreements with customers and/or suppliers
  • Audit of external suppliers and contract laboratories
  • Deviation and CAPA Systems
  • Change management system
  • Continuous improvement of quality system effectiveness
  • Analytical method implementation and validation
  • Qualification and validation of equipment, process, products and cleaning
  • Product reviews and internal audits

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INFORMATION