{"product_id":"qc-labs-mirela-gorjanu-9798285583219","title":"Qc Labs: The Ultimate Guide to Pharmaceutical Analytical Testing and Compliance","description":"\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: \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\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Mirela Gorjanu\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798285583219\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Independently Published\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 05\/28\/2025\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 116\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.47lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.00h x 7.00w x 0.24d","brand":"Mirela Gorjanu","offers":[{"title":"Paperback","offer_id":48996927209727,"sku":"9798285583219","price":9.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.whiterainbookhouse.com\/products\/qc-labs-mirela-gorjanu-9798285583219","provider":"WR Book House","version":"1.0","type":"link"}