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.