Attached is the section of the Drug GMP “211.68 Automatic, Mechanical, and Electrical Equipment”.

This section describes basic requirments for computer systems and automated equipment used in the manufacture, processing, packing, and holding of a drug product.

It emphasize input/output verification for data and formulas with the degree and frequency of such checks being based on system complexity and reliability. It also empahsizes backups.

SoftwareCPR keywords: software, drugs, pharmaceuticals, CBER, biologic