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Engineering aspects such as raw material selection, process validation, process flow, and equipment and facility cleaning protocols are reviewed.
It has been also ensured that properly pulsed long enough activation time scenarios along with proper fusion relevant materials are included in the validation process.
The details of the complete validation process are given in the Supplementary material.
We report here on the data obtained for the quality-control materials used with the first 860 batches, and the validation process used.
Importantly, in the cardiac cell therapy field the ATMP validation process relies upon intrinsic features of the starting material.
The validation process, the article says, should exclude "extraneous or outrageous material," but remain flexible enough "to permit rapid posting of virtually any legitimate work".
This validation process can take years.
The validation process comprises three stages.
A successful validation process is performed.
"There is no validation process which clearly identifies that the comments made are representative of the people using the service".
The first step of this validation process was the forward/backward translation of the CARAT10.
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