Larka

QA/QC

Customer Experience - Biotech company requested Larka to carry out the quality audit of a CMO which would be in charge of manufacturing a clinical batch for one of its biotech products.

 
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Quality Matters.

Context

Biotech company requested Larka to carry out the quality audit of a CMO which would be in charge of manufacturing a clinical batch for one of its biotech products - insulin liquid sterile product. Final objective of the audit was to prepare the biotech’s QP's visit and anticipate potential observations so the QP would not reject the CMO.

Company Profile

  • European company
  • 100 employees
  • 20mn EUR of revenue
  • 2 marketed products and 7 in development

Larka's Scope Of Intervention

Larka's project management team covered the following tasks:

  • Audit preparation
    • Documents review
    • Audit agenda preparation
  • On-site audit
    • Introduction of the CMO and quality system
    • Visit and assessment of the site according to the workflow
    • Interviews
    • Document analysis
    • Data synthesis and analysis
    • Preliminary report
    • Wrap-up
  • Audit report drafting
    • Synthesis
    • Observation classification
    • Recommendations

Conclusion

Three major observations have been made - regarding the water for injection that is used, glass vials inspection, and storage - as well as twelve other minor observations.

Several recommendations were sent to the CMO and Larka followed-up the project to help the CMO set up all the corrective actions/preventive actions, for them to match the biotech company quality requirements.