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.
- 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
- Document analysis
- Data synthesis and analysis
- Preliminary report
- Audit report drafting
- Observation classification
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.