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GTP Scenario # 5

GTP Scenario # 5. September 17,2005. Scenario # 5. The CTL is hospital-based and manufactures 351 & 361 products. The hospital Microbiology Lab performs sterility testing for the CTL. FDA Registration: The CTL registers and checks the ‘process’ box on the 3356 form.

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GTP Scenario # 5

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  1. GTP Scenario # 5 September 17,2005

  2. Scenario # 5 • The CTL is hospital-based and manufactures 351 & 361 products. • The hospital Microbiology Lab performs sterility testing for the CTL. • FDA Registration: • 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. • Micro Lab says “No”.

  3. Micro Lab Registration • 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. • However, the Micro Lab may complete a separate registration.

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

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