OBJECTIVE:
“I need to perform a GMP compliance audit of my preferred contract manufacturing organisation (CMO) or testing laboratory, in order to meet my legal obligations and be assured that my drug can meet the quality standards for clinical trials.”
SCOPE FOR CEREBRO CMC:
> Familiarise with the drug’s manufacturing history
> Co-ordinate with CMO to schedule audit dates
> Prepare an audit agenda
> Travel to CMO to perform on-site audit by a Cerebro CMC quality auditor
> Optional: add one Cerebro CMC technical expert to support the lead auditor
> Provide immediate summary feedback to client
> Generate a formal audit report including CAPA plan
> Issue report to client and CMO
> Review CMO response and advise client on GMP status
TIMELINE:
An audit package typically spans a time period of up to 3 months to allow time to schedule the audit. Actual planning, auditing, reporting and receipt of CMO responses typically span a period of up to 4 weeks.