OBJECTIVE:
“I am outsourcing the manufacture of my clinical phase drug and operating virtually, but need a minimal quality management system built in-house to ensure I have good control over my contractors and release of drug into clinical trials.”
SCOPE FOR CEREBRO CMC:
> Familiarise with the client’s current organisation and near-term plans
> Tailor Cerebro CMC’s QMS Essentials pack to meet the needs of the client while fulfilling regulatory expectations
> Generate policies and procedures based on Cerebro CMC templates
> Refine documents based on client comments and client specificities
> Manage reviews and approvals of QMS documents
> Develop initial training plan for client staff
> Optional: provide training of client staff on their relevant procedures
TIMELINE:
Implementation of the QMS Essentials package typically spans a period of up to 6 months, but can be accelerated with adequate client commitment of in-house resources.