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
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