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Article: Qualification of quality control laboratory equipment
- Article from:
- Biopharm International
- Article date:
- January 1, 1998
- Author:
CopyrightCopyright Advanstar Communications, Inc. Jan 1998. Provided by ProQuest LLC. (Hide copyright information)
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The requirement for an equipment performance assurance program is stated in the Good Manufacturing Practices of the U.S. FDA: "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. Such equipment must 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" (1).
Laboratory equipment qualification (EQ) is one part of a total program to ensure that lab equipment is ...