Quality Assurance

Whether you are a pharmaceutical, biotech, medical device, or dietary supplement company, you must comply with the appropriate FDA Good Manufacturing Practice (GMP) standards. This requirement applies to sponsor companies of all sizes, from small virtual companies to large multi-national organizations.  The expectation of the FDA is that you have control of your internal processes and external partners. You must have robust Quality oversight and a well-defined supplier qualification process. 
Jeiven can help your organization stay compliant with global regulatory requirements through our QA/QC services. For some clients, we serve as the Quality unit and conduct all the Quality activities that are typically handled by internal Quality teams.

Areas we can assist with include:

  • Batch Record Review and Product Release
    • Review batch records, including those of your CMO (manufacturing and/or packaging/labeling contractor) to ensure adherence to GMPs and your technical requirements 
    • Review certificates of analysis, raw material specifications, analytical methods 
    • Review change requests and deviation investigations
  • Monitoring
    • On-site monitoring of manufacturing, testing, packaging, and labeling operations
    • Immediate notification and prompt resolution of any deviations 
  • Standard Operating Procedure (SOP) Preparation and Evaluation
    • Review and revise existing SOPs
    • Author new SOPs 
    • Provide QA approval of SOPs
    • Provide an annual review of your SOPs

Learn about our SOP training

  • Quality and Technical Agreements
  • Maintaining control of your contractors and providing the required oversight includes having robust Quality and Technical agreements in places. We can:
    • Review your existing agreements
    • Provide a gap analysis of those agreements
    • Author new template agreements
  • Audits - Worldwide – for more information click here
  • Controlled temperature management of clinical and commercial products
    • Warehouse qualification including mapping
    • Refrigerator and freezer qualification including mapping
    • Interpretation of Good Distribution Practices
    • Review of internal practices
    • Qualifying shipping and storage vendors including 3PL partners
  • Validation/Qualification
    • Equipment qualification: IQ/OQ/PQ
    • Guide analytical method validation activities appropriate for phase of development
      • Review protocols and reports
    • Guide process validation
      • Review protocols and reports, assess impacts of deviations 
  • Deviation/Complaint Management/CAPA
    • Assist program improvements to make system more robust
      • Proper investigations
      • Root cause analysis
      • Risk assessment
      • Report writing
      • Follow-up activities including effectiveness verification
  • Data Integrity
    • Documentation and archiving practices
    • Handling raw data, equipment printouts, and ‘data sheets’
    • Proper notebook and batch record practices
    • Form (re)design for streamlined information capture
    • Review computer-based system access and permissions
  • Other QA/QC Services
    • Review of randomization schedules and medication ID lists (‘kit lists’)
    • IMP master label text and label proof review
    • Stability program management:
      • Development of stability protocols
      • Assessment of cumulated test results
      • Shelf-life estimation
  • Training
    We can provide on-site customized topics including: GMP, GCP, GLP, Good Documentation Practices, Data Integrity, and Preparing for an FDA Inspection. Click here to learn more