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GTP Scenario # 5

This scenario outlines the FDA registration processes for a hospital-based CTL (Clinical Testing Laboratory) that manufactures 351 and 361 products. It describes the relationship between the CTL and its Microbiology Lab, including their sterility testing responsibilities. It details the steps taken for registration with the FDA, including the CTL's interactions with the Micro Lab. The scenario also explores implications of registration and options available for CTL, along with considerations for higher-level hospital authority discussions.

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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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