Quality Organization

Quality Organization

Our Quality Organization consists of Quality Control (QC) and Quality Assurance (QA). The Quality Unit at each site maintains the cGMP quality system to support biopharmaceutical product manufacturing and to fulfill current regulatory requirements.

As a CMO, CMC Biologics is subject to constant evaluation of our quality systems by our customers. Our Quality Units work closely with internal and customer project teams to meet project requirements and ensure regulatory compliance. We are committed to continuous quality improvement; our goal is to always provide biopharmaceutical products that meet current safety and quality standards.

Quality Control
The main purpose of QC is to control the raw materials, in-process, stability, and release testing analyses for our customers. In addition, QC is responsible for the environmental control of the production facilities. Quality Control responsibilities include:

  • Testing of cell banks, raw materials, reference materials, and other materials for cGMP production
  • Monitoring of critical product contact utilities (WFI, HPW, clean steam, and compressed air) for cGMP production
  • Handling of raw material and product reference samples
  • Analytical method implementation and validation
  • In-process, intermediate, and final product release testing (bulk drug substance, drug product)
  • Analyses of samples from process and cleaning validation studies
  • Process characterization studies
  • Environmental monitoring of classified cGMP production areas
  • ICH-compliant cGMP stability program (intermediates, bulk drug substance, drug product, and placebo)
  • Cell-based bioassays

Quality Assurance
The main purpose of QA is the enhancement and continual improvement of product and service quality, Qualified Person (QP) release of batches, and ensuring high customer satisfaction. QA functions include:

  • Disposition of bulk drug substance
  • Cell bank and raw material release
  • QP release of Investigational Medicinal Product (IMP)
  • cGMP and regulatory support (e.g., IND, IMPD)
  • Quality agreements with customers and suppliers
  • Audit of external suppliers and contract laboratories
  • Deviation and CAPA systems
  • Change management system
  • Continuous improvement of our quality system effectiveness.
  • Staff training and compliance with the requirements of the quality system
  • Qualification and validation of equipment, process, products, and cleaning
  • Product review and internal audits
Right. On time.