Laboratory Equipment Qualification

The main goal in qualifying laboratory equipment is to ensure the validity of data.The current equipment qualification programs and procedures used within the pharmaceutical industry are based o­n regulatory requirements, voluntary standards, vendor practices, and industry practices.The result is considerable variation in the way pharmaceutical companies approach the qualification of laboratory equipment and the way they interpret the often vague requirements.The authors summarize the conclusions of the PhRMA Workshop o­n Acceptable Analytical Practices for the topic “Qualification of Laboratory Equipment.” They describe the areas ofagreement and offer options for areas in which there is variation o­n what is appropriate.

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Author(s):
Kenneth W. Sigvardson, Joseph A. Manalo,Robert W. Roller, Fatieh Saless, and David Wasserman.