Good Manufacturing Practice Fee Structure
Fees will be provided Service Request Form will be provided by contacting:
Jessica L. Rousset
Director, Office of Technology Transfer
Phone: (323) 361-4531
Fax: (323) 361-6841
JRousset@chla.usc.edu
Requirements for Services
The GMP Core requires every user of its services and facilities to become familiar with the processes and procedures for use of the facilities. The GMP Core will require the following information from the user:
- Copies of the IRB and IND approvals (or status information if planned or pending)
- Description of the product and its intended use
- Approved protocols for cell manufacturing and testing
- Special Equipment or other special requirements
- Approximate cost of reagents, supplies etc if these are to be ordered through the hospital's system
- Expected support from personnel (support with IND filing, assistance with audits etc)
- Disclosure of any contractual obligations (e.g., research or clinical research agreement, MTA, CDA, etc.)
- Disclosure of liability issues
The user agrees to pay all fees incurred by the GMP Core as agreed to prior to the commencement of services. Should failures and/or mistakes occur or should deviations from the originally defined services be required, additional fees may apply and will be determined on a project basis in consultation with the user.
All non-hospital users shall be required to enter into a lease agreement with the hospital prior to accessing the GMP Core.
|