HPLC Assay Method Validation Guide: Practical Pharmaceutical Method Validation, Troubleshooting, Data Integrity, GMP Compliance & Regulatory Insights ... Applied Knowledge for Pharma Professionals) - Softcover

HPLC Assay Method Validation Guide : Practical Pharmaceutical Method Validation, Troubleshooting, Data Integrity, GMP Compliance & Regulatory Insights for Analytical Scientists

Taschenbuch. Zustand: Neu. Neuware - Your HPLC method passed development. Will it survive validation - and the audit after The HPLC Assay Method Validation Guide is a visual, bench-ready reference for pharmaceutical analysts, QC laboratories and analytical scientists who need validation work to be right the first time. Written by a practising pharmaceutical analytical scientist, it turns regulatory requirements into clear, structured steps you can apply in the lab immediately.Inside you'll find: - Method validation, parameter by parameter, aligned with ICH Q2 expectations- Real-world troubleshooting for the chromatographic problems that derail validation runs- Data integrity and GMP compliance - what auditors look for and how to stay inspection-ready- Chromatogram interpretation with colour-coded, infographic-style explanations- Workflows and templates that bring structure to protocols and reports- Regulatory insights that connect the science to FDA and ICH requirementsWho it's for: QC and R&D analysts, method development and validation scientists, lab supervisors, QA reviewers, and graduates entering regulated pharmaceutical laboratories.Part of the Practical Pharma Science(TM) series - applied knowledge for pharma professionals.- Mirela Gorjanu, Practical Pharma Science(TM). Artikel-Nr. 9798196240096

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