English to Russian Medical Medical: Pharmaceuticals

2.3.2 Sample Batch File / Device History Record
Tables 2.2 and 2.3 list SOPs used to compile manufacturing and packaging batch
records. The device evaluation system for ХХХ is based on:
a) rigorous in-process control (IPC) tests performed during the manufacture of
each batch of NaHA and during formulation;
b) comprehensive environmental monitoring of the aseptic filling process;
c) QC testing of the NaHA and finished product during manufacture, and before
and after terminal sterilization of the finished product.