Case Study: Test Method Validation (TMV)

A large, world class manufacturer of disposable therapeutic products was transferring a product from a small acquired startup and needed to have the test methods for all the required manufacturing testing validated, and in some cases developed as well.

AlvaMed supplied a small team of engineers experienced in both disposable manufacturing and test method validation who worked on-site at the foreign manufacturing facility with the facility's manufacturing engineers. In addition to the development work performed, the AlvaMed engineers wrote the the TMV protocols, executed the protocols themselves or supervised the execution of the protocols, and wrote the validation reports.

All the TMVs were ultimately successful. Some TMVs were insufficiently  developed by the acquired startup, resulting in AlvaMed further developing these test methods in order for them to pass TMV.

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control