ABSTRACT
The US cGMPs make four specific references to validation in the contexts, respectively, of computer systems, supplier test results, sampling and testing in-process materials, and sterilization processes. These are:
(a) Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.
