Direct Links to important GMP Validation Guidelines

Draft: Question and answers on implementation of risk based prevention of cross contamination in production and Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared f

The document interpretats the EMA Guideline on setting health based exposure limits... (EMA/CHMP/CVMP/SWP/169430/2012)

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Question and answers on implementation of risk based prevention of cross contamination in production and Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared faciliti

The document interpretats the EMA Guideline on setting health based exposure limits... (EMA/CHMP/CVMP/SWP/169430/2012)

more

FDA Guidance for Industry: Bioanalytical Method Validation

This guidance helps sponsors of investigational new drug applications (INDs) or applicants of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation

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ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation - Final Concept Paper

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GMP Conferences by Topics

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