Quality

Quality Control
BIOMEVA's Quality Control (QC) and Quality Assurance (QA) departments ensure that facilities, equipment, critical materials, API and cell bank manufacturing are fully cGMP-compliant. To support all cGMP manufacturing activities, the QC group is responsible for supporting manufacturing in the following activities:

 

  • Testing and release of raw materials to the manufacturing group
  • Sample testing during the manufacturing process
  • Environmental monitoring of the production suites during and between manufacturing campaigns
  • Release testing of the active pharmaceutical ingredient

Quality Assurance
The Quality Assurance (QA) group ensures the cGMP-compliant API and cell bank manufacturing, which often exceeds client's expectations. BIOMEVA's QA auditors provide inspection, auditing and monitoring of all production activities including:

 

  • Working with clients and regulatory agencies during audits
  • Performing in-process and system inspections
  • Auditing Master Production Records and any completed GMP documents
  • Reviewing products’ Certificate of Analysis and approving release of products to the client
  • Confirming that all relevant SOP's are followed
  • Inspecting all cleaning and change-over activities