English to Russian Medical Medical: Pharmaceuticals

This validation protocol requires all of this data to be summarized and compared to the product and process requirements, these product requirements are listed in Appendix 1.
A comparison summary will be presented in the Final Report.
Process variables which are collected For Information Only (FIO) will also be summarized in the Final Report, the only additional testing required by this protocol is described in Section 9.0.
This section describes how lyophilized vials will be geographically sampled from the lyophilizer chamber in order to demonstrate lot uniformity throughout the load and *over the length of the fill*.