{"product_id":"qc-labs-the-ultimate-guide-to-pharmaceutical-analytical-testing-and-compliance-9798285583219","title":"Qc Labs: The Ultimate Guide to Pharmaceutical Analytical Testing and Compliance","description":"\u003cp\u003e • Author(s): Mirela Gorjanu\u003cbr\u003e • Publisher: Independently Published\u003cbr\u003e • Publisher Imprint: Independently Published\u003cbr\u003e • BISAC: Schools - Levels - Higher\u003c\/p\u003e\u003cp\u003e\u003cb\u003eQC LABS: The Ultimate Guide to Pharmaceutical Analytical Testing and Compliance\u003c\/b\u003e\u003cbr\u003e\u003ci\u003eA Comprehensive Guide to Pharmaceutical Analytical Testing\u003c\/i\u003e\u003cbr\u003eIn the ever-demanding world of pharmaceutical manufacturing, \u003cb\u003eanalytical accuracy is non-negotiable\u003c\/b\u003e. \u003cb\u003e\u003ci\u003eQC LABS: The Ultimate Guide to Pharmaceutical Analytical Testing and Compliance\u003c\/i\u003e\u003c\/b\u003e offers an all-in-one, deeply practical resource for professionals working in \u003cb\u003equality control, regulatory compliance, and laboratory management\u003c\/b\u003e.\u003cbr\u003eSpanning every major test, technique, and regulatory expectation, this guide walks you step-by-step through: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eFundamental and advanced \u003cb\u003eanalytical procedures\u003c\/b\u003e (assay, ID, impurities, dissolution, etc.)\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eMethod validation\u003c\/b\u003e under ICH Q2(R2), including LOD\/LOQ, robustness, and precision\u003c\/li\u003e\n\u003cli\u003eChromatographic systems (HPLC, UPLC, GC) and spectroscopic tools (UV-Vis, FTIR, NMR)\u003c\/li\u003e\n\u003cli\u003eMicrobiological testing, \u003cb\u003esterility\u003c\/b\u003e, and \u003cb\u003eendotoxin controls\u003c\/b\u003e per USP,, \u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eData integrity\u003c\/b\u003e best practices aligned with 21 CFR Part 11 and ALCOA+ principles\u003c\/li\u003e\n\u003cli\u003eFull lifecycle of \u003cb\u003einstrument qualification\u003c\/b\u003e, \u003cb\u003eLIMS\/CDS integration\u003c\/b\u003e, and \u003cb\u003emethod transfer\u003c\/b\u003e\n\u003c\/li\u003e\n\u003cli\u003eAudit-readiness checklists, regulatory red flags, and global compliance strategies\u003c\/li\u003e\n\u003c\/ul\u003ePacked with \u003cb\u003eappendices, SOP templates, validation formats\u003c\/b\u003e, and reference tables, this book empowers pharmaceutical professionals to build and maintain \u003cb\u003einspection-ready, scientifically sound\u003c\/b\u003e QC laboratories.\u003cbr\u003eWhether you're a seasoned analyst, QA specialist, auditor, or manager, this handbook will serve as your definitive companion for navigating the \u003cb\u003ecritical landscape of pharmaceutical analytical testing\u003c\/b\u003e.\u003cbr\u003e","brand":"Atlantic Books","offers":[{"title":"Paperback","offer_id":46335647580311,"sku":"9798285583219","price":861.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9798285583219.webp?v=1768675495","url":"https:\/\/atlanticbooks.com\/products\/qc-labs-the-ultimate-guide-to-pharmaceutical-analytical-testing-and-compliance-9798285583219","provider":"Atlantic Books","version":"1.0","type":"link"}