HPLC Assay Method Validation Guide : Practical Pharmaceutical Method Validation, Troubleshooting, Data Integrity, GMP Compliance & Regulatory Insights for Analytical Scientists
Language: English
Published by Amazon Digital Services LLC - Kdp Mai 2026, 2026
Series: Book 1 of 14 - Practical Pharma Science™ - Applied Knowledge for Pharma Professionals
- Softcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
Condition: New
£ 31.43
Quantity: 2 available
Add to basketItem description from seller
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).…
Seller Inventory # 9798196240096
- Title
- HPLC Assay Method Validation Guide : Practical Pharmaceutical Method Validation, Troubleshooting, Data Integrity, GMP Compliance & Regulatory Insights for Analytical Scientists
- Author
- Mirela Gorjanu
- Publisher
- Amazon Digital Services LLC - Kdp Mai 2026
- Publication year
- 2026
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 13
- 9798196240096
- Item weight
- 390 grams
- Dimensions
- 279x216x9 mm
- Series
- Book 1 of 14: Practical Pharma Science™ - Applied Knowledge for Pharma Professionals
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 requirements
Who 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™ series — applied knowledge for pharma professionals.
— Mirela Gorjanu, Practical Pharma Science™
"Synopsis" may belong to another edition of this title.
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