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.
Sunday, March 21, 2010
Laboratory Equipment Qualification
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K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
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The main goal in qualifying laboratory equipment is to ensure the validity of information.The current equipment qualification programs and also processes used in the pharmaceutical industry are really based on regulatory requirements, voluntary requirements, vendor methods, and additionally industry techniques.The result is considerable variety inside the way pharmaceutical companies approach the degree of laboratory gear and also the way the couple understand the often vague needs.The authors summarize the conclusions of the PhRMA Workshop on Acceptable Analytic Methods for the topic “Qualification of Laboratory Gear.” The couple describe the areas ofagreement and additionally offer options for areas when there is variety on exactly what is appropriate.
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