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Hospital-Based CTL and Micro Lab Registration Process for Sterility Testing

This scenario outlines the registration process for a hospital-based CTL that manufactures 351 and 361 products. It details how the CTL relies on its Microbiology Lab for sterility testing and the implications of FDA registration. The CTL checks the 'process' box on the 3356 form and inquires about the Micro Lab's need for separate registration. The Micro Lab is deemed covered by the CTL's registration; however, options are discussed regarding registration acknowledgment and exploring alternative sterility testing facilities.

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Hospital-Based CTL and Micro Lab Registration Process for Sterility Testing

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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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