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GXP CSV Process Validation Cleaning Validation

GXP
Nov 17 2021 - 4:42 pm
It is FDA’s expectation that stringent controls to prevent contamination be established. All manufacturers shall understand that pathogens vary among different animal species. Healthy animals can be...
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JVT
Dec 16 2021 - 5:34 pm
Revision of the ICH Q9 Quality Risk Management (QRM) guideline was released for public comment in December 2021. In the EU, the public consultation period begins on mid December and will continue for...
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JVT
Feb 24 2022 - 4:19 pm
Mycoplasmas can alter infected cells at the molecular level and trigger visible changes in cell morphology and growth characteristics. Cell lines are of great importance of biopharmaceutical...
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GXP
Nov 20 2019 - 12:12 pm
This article outlines the Riboprinting technology and discusses some applications of the approach, which can assist within investigations within the pharmaceutical context.
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GXP
Nov 19 2021 - 10:14 am
This paper continues a series of discussions addressing the application of validation principles to the Training Quality System (TQS). Training process documentation -- specific documentation...
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