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GXP • CSV • Process Validation • Cleaning Validation
JVT
Aug 22 2018 - 12:41 pm
Discontinuities are a crucial but unaddressed issue within PV, and they are not the exception but the norm, and should be treated accordingly. Several examples are included in support of the premise...
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JVT
Aug 23 2018 - 8:07 am
The FDA communicates the importance of quality metrics and their intent to implement a Quality Metrics program. Validation is a critical indicator of the quality of processes and system during their...
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JVT
Aug 23 2018 - 6:55 am
In this paper, we will examine a simple method to design a sampling plan for process validations. Using a simple five step method, you can construct a statistically valid sampling plan for either...
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GXP
Jul 24 2018 - 12:59 pm
In order to prepare for a successful FDA inspection, QC management and analysts must know and understand the types of FDA inspections and their purpose, the Good Manufacturing Practice (GMP)...
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