Hi to everybody,
In my Plant, the Manufacturing Unit proposed a development trial, an experimental protocol, to demonstrate the homogeneity of API product during the final filtration of Drug Substance. This Protocol describes the single use mixing system.
Do I need to qualificate the single use “equipment” of the Vendor before to start the trial or not? … Somebody says that durind development experimental trial it doesn’t need use qualified equipment (as per GMP exercise); moreover, it will be a trial using a single use equipment by a notorious Vendor.
What do you think about? Can you help me? Did anybody have experience about ?
Thank you in advance