QC Labs : A Practical Guide for Analytical Methods
Language: English
Published by Amazon Digital Services LLC - Kdp Mai 2025, 2025
- Softcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
Condition: New
£ 21.14
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Add to basketItem description from seller
Neuware - QC Labs: A Practical Guide for Analytical MethodsAuthor: Mirela Gorjanu, MScYour blueprint for mastering pharmaceutical quality control.In a world where regulatory scrutiny, data integrity, and patient safety define success, QC Labs: A Practical Guide for Analytical Methods is the trusted companion every pharmaceutical professional needs.This comprehensive and deeply practical guide walks you through the full spectrum of quality control operations from foundational lab setup and instrument qualification to advanced method validation, risk-based decision-making, and regulatory inspection readiness. Whether you're a QC analyst, QA specialist, regulatory affairs professional, or laboratory manager, this book is your essential toolkit.Inside, you'll find: - Step-by-step instructions for HPLC, GC, spectroscopy, titration, and microbiological testing- ICH, FDA, and EMA-compliant method validation frameworks- Real-world case studies, audit checklists, and troubleshooting references- Sample SOPs, data integrity principles, and ALCOA+ best practices- Emerging technologies: LIMS, PAT, automation, AI, and real-time release strategiesWritten in clear, accessible language by pharmaceutical chemist Mirela Gorjanu, this book bridges theory and execution, empowering professionals to meet the highest standards of compliance and lab excellence. …
Seller Inventory # 9798284800621
- Title
- QC Labs : A Practical Guide for Analytical Methods
- Author
- Mirela Gorjanu
- Publisher
- Amazon Digital Services LLC - Kdp Mai 2025
- Publication year
- 2025
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 13
- 9798284800621
- Item weight
- 141 grams
- Dimensions
- 229x152x5 mm
- Series
- Book 5 of 50: Pharmaceutical Industry
Author: Mirela Gorjanu, MSc
Your blueprint for mastering pharmaceutical quality control.
In a world where regulatory scrutiny, data integrity, and patient safety define success, QC Labs: A Practical Guide for Analytical Methods is the trusted companion every pharmaceutical professional needs.
This comprehensive and deeply practical guide walks you through the full spectrum of quality control operations from foundational lab setup and instrument qualification to advanced method validation, risk-based decision-making, and regulatory inspection readiness. Whether you're a QC analyst, QA specialist, regulatory affairs professional, or laboratory manager, this book is your essential toolkit.
Inside, you'll find:
✔ Step-by-step instructions for HPLC, GC, spectroscopy, titration, and microbiological testing
✔ ICH, FDA, and EMA-compliant method validation frameworks
✔ Real-world case studies, audit checklists, and troubleshooting references
✔ Sample SOPs, data integrity principles, and ALCOA+ best practices
✔ Emerging technologies: LIMS, PAT, automation, AI, and real-time release strategies
Written in clear, accessible language by pharmaceutical chemist Mirela Gorjanu, this book bridges theory and execution, empowering professionals to meet the highest standards of compliance and lab excellence.
"Synopsis" may belong to another edition of this title.
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