English to Russian Medical Medical: Pharmaceuticals

The design and development of the packaging system is governed by PR574-001 Procedure for Package Design for North America to minimize the safety hazards to patients and users, maintain package integrity and stability overtime, and to assure sterility of the device.
Design Requirements Matrix
Packaging occurs on-site at the specific manufacturing sites indicated in Part A.6 Design and Manufacture Locations.
Packaging design verification and validation testing data is referenced in the Design Requirements Matrix (DRM) referenced in Part B.9 Design Verification and Validation, and hold in the Device History File (DHF) in TRIM and/or *Master Validation Index* (MVI) structures within ADAPTIV.
The site sterilizes the product using the validated modality and process utilizing validated equipment and meeting the Design and Material Specifications (Part B.8 Design Specification) which meet the finished goods/product specifications.