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© 2021 MJH Life Sciences and Chromatography Online. All rights reserved.
© 2021 MJH Life Sciences™ and Chromatography Online. All rights reserved.
Are your OOS investigations scientifically sound and is the assignable cause correct? Or are OOS results invalidated using the ever-popular justification of analyst error?
The United States Pharmacopeia general chapter on Analytical Instrument Qualification has been updated and became effective 1 August 2017. So, what has changed?
The authors discuss metrics for monitoring data integrity within a chromatography laboratory, from the regulatory requirements to practical implementation.