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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Saturday, December 5, 2009
Laboratory Equipment Qualification
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Validation of the Autoclave is classified into the following 1.0 OQ – Operational Qualification 2.0 PQ – Performance Qualification The valid... -
K. Dashora, D. Singh, Swarnlata Saraf and S. Saraf *. Institute of Pharmacy, Pt.RavishankarShuklaUniversity, Raipur 492 010. *Author for ...
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2.0 Scope: Final visual inspection is performed manually by human operators. Prior to being qualified as an inspector, each in...
1 comment:
we have probably seen the equipment before.
Our consultants will use their experience from many sites to ensure that critical to quality parameters are considered during this process.
We've seen what works and what definitely doesn't.
equipment validation
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