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Qc Labs: The Ultimate Guide to Pharmaceutical Analytical Testing and Compliance by Gorjanu, Mirela

Qc Labs: The Ultimate Guide to Pharmaceutical Analytical Testing and Compliance

by Mirela Gorjanu
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Book cover type: Paperback
  • ISBN13: 9798285583219
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Independently Published
  • Publisher Imprint: Independently Published
  • Publication Date:
  • Pages: 116
  • Original Price: GBP 7.48
  • Language: English
  • Edition: N/A
  • Item Weight: 214 grams
  • BISAC Subject(s): Schools / Levels / Higher

QC LABS: The Ultimate Guide to Pharmaceutical Analytical Testing and Compliance
A Comprehensive Guide to Pharmaceutical Analytical Testing
In the ever-demanding world of pharmaceutical manufacturing, analytical accuracy is non-negotiable. QC LABS: The Ultimate Guide to Pharmaceutical Analytical Testing and Compliance offers an all-in-one, deeply practical resource for professionals working in quality control, regulatory compliance, and laboratory management.
Spanning every major test, technique, and regulatory expectation, this guide walks you step-by-step through:

  • Fundamental and advanced analytical procedures (assay, ID, impurities, dissolution, etc.)
  • Method validation under ICH Q2(R2), including LOD/LOQ, robustness, and precision
  • Chromatographic systems (HPLC, UPLC, GC) and spectroscopic tools (UV-Vis, FTIR, NMR)
  • Microbiological testing, sterility, and endotoxin controls per USP,,
  • Data integrity best practices aligned with 21 CFR Part 11 and ALCOA+ principles
  • Full lifecycle of instrument qualification, LIMS/CDS integration, and method transfer
  • Audit-readiness checklists, regulatory red flags, and global compliance strategies
Packed with appendices, SOP templates, validation formats, and reference tables, this book empowers pharmaceutical professionals to build and maintain inspection-ready, scientifically sound QC laboratories.
Whether you're a seasoned analyst, QA specialist, auditor, or manager, this handbook will serve as your definitive companion for navigating the critical landscape of pharmaceutical analytical testing.

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