GTP Scenario # 5 September 17,2005

Scenario # 5 The CTL is hospital-based and manufactures 351 & 361 products. The CTL is hospital-based and manufactures 351 & 361 products. The hospital Microbiology Lab performs sterility testing for the CTL. The hospital Microbiology Lab performs sterility testing for the CTL. FDA Registration: FDA Registration: The CTL registers and checks the ‘process’ box on the 3356 form. The CTL registers and checks the ‘process’ box on the 3356 form. The CTL contacts the Micro Lab and requests that they register with the FDA. The CTL contacts the Micro Lab and requests that they register with the FDA. Micro Lab says “No”. Micro Lab says “No”.

Micro Lab Registration Does the Micro Lab need to complete a separate registration form? Does the Micro Lab need to complete a separate registration form? No, the Micro Lab is ‘covered’ by the CTL registration. Since the CTL checked the ‘process’ box, this also covers In-House Micro testing. No, the Micro Lab is ‘covered’ by the CTL registration. Since the CTL checked the ‘process’ box, this also covers In-House Micro testing. However, the Micro Lab may complete a separate registration. However, the Micro Lab may complete a separate registration.

CTL Options CTL checks the ‘process’ box and thereby registers Micro Lab. CTL checks the ‘process’ box and thereby registers Micro Lab. Tell Micro they are registered. Tell Micro they are registered. Don’t tell Micro they are registered. Don’t tell Micro they are registered. CTL finds another sterility testing facility that is registered. CTL finds another sterility testing facility that is registered. CTL discusses the situation within the hospital at a ‘higher level of authority’. CTL discusses the situation within the hospital at a ‘higher level of authority’.