{"product_id":"analytical-instrumentation-gmp-qc-laboratory-guide","title":"Operational Guide to Analytical Instrumentation in the GMP QC Laboratory (First Edition + Toolkit)","description":"\u003cdiv style=\"font-family:-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif;color:#26291F;line-height:1.65\"\u003e\u003cdiv style=\"background:#1D1F1A;border-radius:14px;padding:34px 30px 30px 30px;color:#ffffff;margin-bottom:26px;border-bottom:4px solid #C3D432\"\u003e\u003cdiv style=\"display:inline-block;background:#C3D432;color:#1D1F1A;font-size:12px;font-weight:700;letter-spacing:1.6px;text-transform:uppercase;padding:6px 12px;border-radius:4px;margin-bottom:16px\"\u003eFirst edition · v1.0 · regulatory verification 02\/10\/2026\u003c\/div\u003e\u003ch3 style=\"margin:0 0 12px 0;font-size:28px;line-height:1.25;color:#ffffff;font-weight:800\"\u003eSystem suitability is not qualification, a qualified instrument is not a valid result, an informational chapter is not an obligation: QC laboratory instruments governed with the source next to every value.\u003c\/h3\u003e\u003cp style=\"margin:0 0 20px 0;font-size:16px;color:#E3E4DB;max-width:700px\"\u003eA quality and technical guide for those who select, qualify, verify, repair and govern the analytical instruments of the GMP QC laboratory: analytical qualification and reliability, HPLC and UHPLC, GC and headspace, spectroscopy, LC-MS and ICP-MS, dissolution and physical testing, TOC and physicochemical measurements. \u003cstrong\u003e24 chapters in six parts\u003c\/strong\u003e and 6 appendices, 309 pages in the Italian edition and 308 in the English one, and \u003cstrong\u003e24 editable tools\u003c\/strong\u003e in Word and Excel, for €199.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:9px\"\u003e\u003cspan style=\"background:#34382C;color:#E3E4DB;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e309 pages (ITA) · 308 (ENG) · PDF A4\u003c\/span\u003e\u003cspan style=\"background:#34382C;color:#E3E4DB;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e24 chapters in six parts + 6 appendices\u003c\/span\u003e\u003cspan style=\"background:#34382C;color:#E3E4DB;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e24 tools: 12 Word + 12 Excel\u003c\/span\u003e\u003cspan style=\"background:#34382C;color:#E3E4DB;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e121 sources in the register\u003c\/span\u003e\u003cspan style=\"background:#34382C;color:#E3E4DB;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e106 tracked decisions\u003c\/span\u003e\u003cspan style=\"background:#34382C;color:#E3E4DB;font-size:13px;padding:7px 13px;border-radius:20px\"\u003eDigital product: download after payment\u003c\/span\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"background:#F5F6EE;border:1px solid #DCDECF;border-left:4px solid #C3D432;border-radius:0 11px 11px 0;padding:16px 20px;margin-bottom:26px;font-size:14.5px;color:#26291F\"\u003e\u003cstrong style=\"color:#56632B\"\u003eOne language per purchase, chosen by the variant.\u003c\/strong\u003e The \u003cstrong\u003eITA - Italiano\u003c\/strong\u003e variant gives you the PDF guide and the 24 tools in Italian; the \u003cstrong\u003eENG - English\u003c\/strong\u003e variant gives them in English. Both editions have the same structure, the same tools and the same codes AN-TK-01…24. There are no files in French, German or Spanish.\u003c\/div\u003e\u003cdiv\u003e\u003ch3 style=\"font-size:22px;margin:0 0 6px 0;color:#1D1F1A\"\u003eThe decisions it helps you make\u003c\/h3\u003e\u003cp style=\"margin:0 0 14px 0;font-size:15px;color:#585B4E;max-width:720px\"\u003eEvery chapter starts from a laboratory decision and closes it with who decides, on what basis and where it is recorded: 106 decision codes, each linked to the tool where it is documented.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:28px\"\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eProgramme, classes and release for use\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eProgramme owner and roles, regimes and texts per instrument and market, a justified class for every instrument and system, the evidence behind the release-for-use signature and how the supplier's IQ\/OQ package is reviewed.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapters 1–2 · AN-TK-01, AN-TK-04\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eURS, bids and TCO\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eNumbered, verifiable requirements with the mandatory ones kept apart, technical bid evaluation, NPV and scenarios with firm and estimated items: no mandatory requirement offset by a score.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapter 3 · AN-TK-02, AN-TK-03\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eIntervals, as-found results and suspect periods\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eCalibration and verification intervals justified on risk and observed drift, out-of-tolerance as-found results with a retrospective assessment, change control, requalification, periodic review and retirement.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapter 4 · AN-TK-05\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eHPLC\/UHPLC OQ and performance verification\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eFlow, gradient, injection, temperature, detector and carryover with stated criteria and calculation conventions; gradient delay volume measured on the installed configuration.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapters 5–6 · AN-TK-06, AN-TK-04\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eSystem suitability and method transfer\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eWhen the analytical system is fit at the time of analysis, which S\/N convention, which systems are allowed by name, and how the delay volume is corrected when a gradient moves to another system.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapter 7 · AN-TK-07, AN-TK-08\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eTroubleshooting and return to service\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eFrom symptom to demonstrated cause with a test that confirms or rules out each hypothesis, verification before reuse and a judgement on results already reported, for HPLC\/UHPLC and GC\/HS.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapters 8 and 12 · AN-TK-09, AN-TK-12\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eGC and headspace\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eGases and point-of-use control, the use of hydrogen, qualification of inlet, oven and detector, the headspace variables to fix in the method and a trend rule on area repeatability.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapters 9–11 · AN-TK-10, AN-TK-11\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eUV-Vis, FTIR and Raman\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eReference materials and certificate conditions, maximum absorbance allowed for each method, cuvettes, wavenumber axis and Raman shift, threshold and challenge of the identity library.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapters 13–14 · AN-TK-13, AN-TK-14\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eLC-MS and ICP-MS\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eMass accuracy convention, contamination, carryover and matrix effects; cell mode, blanks by type, digestion vessels, tuning and recoveries.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapters 15–16 · AN-TK-15, AN-TK-16\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eDissolution apparatus and physical tests\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eEnhanced mechanical calibration, PVT or both, with tolerances from the chosen text; deaeration, dispensing and storage of the medium; disintegration, friability and breaking-force testers.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapters 17–19 · AN-TK-17, AN-TK-18, AN-TK-19\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003ePhase I investigation\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eWhen an abnormal result may be attributed to the instrument, with which contemporaneous evidence, how far back the retrospective assessment goes and who approves an invalidation.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapter 20 · AN-TK-20\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-top:3px solid #C3D432;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eTOC, Karl Fischer, pH and conductivity\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#26291F;margin-bottom:7px\"\u003eResponse efficiency with the blank and vial lots; Karl Fischer titre and drift; buffers, slope and offset; cell constant and stated temperature compensation.\u003c\/div\u003e\u003cdiv style=\"font-size:12.5px;font-weight:600;color:#56632B\"\u003eChapters 21–24 · AN-TK-21…24\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"margin-bottom:26px\"\u003e\u003ch3 style=\"font-size:22px;margin:0 0 8px 0;color:#1D1F1A\"\u003eThe myths it takes apart\u003c\/h3\u003e\u003cp style=\"margin:0 0 14px 0;font-size:15px;color:#585B4E;max-width:720px\"\u003eStatements that circulate as \"requirements\" and that the sources write differently. For each one the guide gives the document, clause, nature and object.\u003c\/p\u003e\u003cdiv style=\"font-size:15px;color:#26291F\"\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003e\"System suitability replaces qualification.\"\u003c\/strong\u003e SST checks the analytical system for that method at the time of use; it does not check parameters the method does not exercise, such as flow, wavelength and temperature accuracy or carryover at other levels. Qualification, method validation and SST are distinct levels (WHO TRS 1052, Annex 4, 5.27 and 6.27) (Chapters 2 and 7).\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003e\"The supplier's IQ\/OQ package qualifies the instrument.\"\u003c\/strong\u003e Supplier tests are an input to be reviewed against the URS and the intended use; responsibility for qualification stays with the laboratory (Chapters 2–3).\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003e\"USP 〈1058〉 is mandatory, and the new version is already in force.\"\u003c\/strong\u003e 〈1058〉 is an informational chapter; the official text is the one official since 01\/08\/2017, and the revision published in the Pharmacopeial Forum is a proposal [DRAFT]. The obligation to qualify comes from GMP: in the USA 21 CFR 211.160(b)(4), 211.63 and 211.68, in the EU Chapter 6, Chapter 3 and Annex 15 (Chapters 1–2).\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003e\"The regulations say how often to calibrate and requalify.\"\u003c\/strong\u003e No text examined sets a value: 21 CFR 211.160(b)(4) asks for \"suitable intervals\", EU GMP for defined intervals and justified requalification periods. \"A common frequency is once a year\" is the example given in the FDA Q\u0026amp;A on laboratory controls for the balance auto-calibrator, not a general rule (Chapter 4).\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003e\"OMCL limits are GMP requirements.\"\u003c\/strong\u003e The OMCL guideline 'Qualification of Equipment' is written for the official control laboratories of the European OMCL network and is not binding on industry; the guide describes its structure and parameters and does not reproduce its numerical limits (Chapters 2–4).\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003e\"An HPLC's delay volume is the typical catalogue figure.\"\u003c\/strong\u003e The gradient delay volume is a property of the specific instrument and is measured: literature values are dated orders of magnitude. In Case A the same method runs on three UHPLC systems with measured delay volumes of 100, 100 and 400 µL [DEMONSTRATION EXAMPLE] (Chapters 5 and 7).\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003e\"FDA withdrew the mechanical calibration guidance, and PVT twice a year is a requirement.\"\u003c\/strong\u003e The January 2010 FDA guidance on mechanical calibration of Apparatus 1 and 2 is current and is referenced by the CDER recognition of ASTM E2503 of 21\/08\/2025: either the USP 〈711〉 performance verification or an enhanced mechanical calibration executed under a written procedure satisfies the calibration requirement. \"At least twice a year\" comes from the 1997 guidance, whose terminology has been superseded: 21 CFR 211.160(b)(4) asks for \"suitable intervals\" and the frequency is justified (Chapter 17).\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003e\"An OOS is invalidated for an instrument problem by repeating the analysis.\"\u003c\/strong\u003e The instrument hypothesis must be demonstrated with contemporaneous evidence; the data of the suspect period must be identified and assessed; without a documented error the investigation continues. The invalidation is approved by the quality function (Chapter 20).\u003c\/p\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:14px;margin-bottom:26px\"\u003e\u003cdiv style=\"flex:1 1 230px;background:#F5F6EE;border:1px solid #DCDECF;border-top:3px solid #56632B;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#56632B;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eThe guide\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#26291F\"\u003e24 chapters in six parts, named after the six subject areas of the Analytical Instrumentation hub, and 6 appendices. Chapters 2–24 follow seventeen fixed sections, always in the same order: \u003cstrong\u003erequirement → interpretation → risk → decision → action → evidence → audit readiness\u003c\/strong\u003e. Four status labels and seven nature labels tell you what each source is worth and in which jurisdiction.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#F5F6EE;border:1px solid #DCDECF;border-top:3px solid #56632B;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#56632B;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eThe toolkit\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#26291F\"\u003e24 editable tools: 12 Word templates and 12 Excel workbooks, each as a clean template and as a filled-in example. The Excel workbooks have a Read_Me with inputs, calculations, checks and limits and the Formulas, Error_Check and Assumptions_Limits sheets, and return only \"Comparison with the entered criteria\" or \"Assessment required\".\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#F5F6EE;border:1px solid #DCDECF;border-top:3px solid #56632B;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#56632B;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eFive integrated cases\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#26291F\"\u003eIn the QC laboratory of the fictitious company Corvessa Pharma: a UHPLC fleet with a delay volume never measured (Case A, with the TCO in Chapter 3), headspace repeatability drifting because of leaking vials (B), digestion blanks and argon-chloride interference on arsenic in ICP-MS (C), a dissolution OOS with a non-deaerated medium (D), TOC system suitability masked by the blank (E). The \"Readiness\" sheet of AN-TK-05 holds 159 inspector questions.\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"background:#F5F6EE;border-left:4px solid #56632B;border-radius:0 11px 11px 0;padding:22px 24px;margin-bottom:30px\"\u003e\u003cdiv style=\"font-size:19px;font-weight:800;color:#56632B;margin-bottom:10px\"\u003eRegulatory status verified as of 02\/10\/2026\u003c\/div\u003e\u003cp style=\"margin:0 0 11px 0;font-size:15px;color:#26291F\"\u003eThe guide describes the regulatory and technical framework as of \u003cstrong\u003e02\/10\/2026\u003c\/strong\u003e; documents published or amended after this date are not considered. Every source carries a status label (current, draft, in development, superseded) and a nature label, with the jurisdiction where it applies. The points that most often change the reading:\u003c\/p\u003e\u003cul style=\"margin:0 0 12px 0;padding-left:20px;font-size:15px;color:#26291F\"\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong\u003eUSP 〈1058〉 'Analytical Instrument Qualification'\u003c\/strong\u003e: the official text is the one official since 01\/08\/2017, an informational chapter [GUIDANCE]; the revision published as a proposal in the Pharmacopeial Forum is a draft and is not official text. In the EU the USP is not a mandatory reference unless committed to in the dossier or chosen by the quality system.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong\u003eWHO TRS 1052, Annex 4\u003c\/strong\u003e 'WHO good practices for pharmaceutical quality control laboratories' (2024) is current and supersedes TRS 957, Annex 1 (2010).\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong\u003eAnnex 11, Chapter 4 and Chapter 1:\u003c\/strong\u003e the 2025 revisions and the new Annex 22 are drafts whose consultation has closed; the 2011 Annex 11 and Chapter 4 and the 2013 Chapter 1 remain in force. Annex 15 (2015) is in force; its revision is in development: EMA concept paper of 19\/01\/2026, draft planned for December 2026.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong\u003eICH Q2(R2) and ICH Q14\u003c\/strong\u003e (Step 4 of 01\/11\/2023, effective in the EU from 14\/06\/2024) cover the development and validation of analytical procedures: they are not guidelines on instrument qualification.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong\u003eDissolution apparatus:\u003c\/strong\u003e the January 2010 FDA guidance on mechanical calibration of Apparatus 1 and 2 is current; CDER recognised ASTM E2503-13(2020) on 21\/08\/2025.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong\u003ePharmacopoeias:\u003c\/strong\u003e Ph. Eur. 12th Edition up to Issue 12.3 and USP–NF 2026, Issue 5 are applicable. Ph. Eur. Issue 13.1 has been published and applies from 01\/01\/2027, Issue 13.2 from 01\/04\/2027: they are not yet requirements.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong\u003eOMCL:\u003c\/strong\u003e the 'Qualification of Equipment' guideline (PA\/PH\/OMCL (08) 73 R7, in force since 15\/11\/2023) is guidance for the laboratories of the OMCL network and does not bind industry; its numerical limits are not reproduced.\u003c\/li\u003e\u003c\/ul\u003e\u003cp style=\"margin:0;font-size:15px;color:#26291F\"\u003e\u003cstrong\u003eUpdates included.\u003c\/strong\u003e Appendix F lists the events that trigger re-verification of the guide: final texts of the revisions of Annex 11, Chapter 4, Chapter 1 and the new Annex 22, the draft revision of Annex 15, the revision of USP 〈1058〉, Ph. Eur. Issues 13.1 and 13.2 becoming applicable, new USP–NF Issues, expiry of the NIST SRM 2241 and 2035b certificates. When the texts change, you receive the revised guide and toolkit at no extra cost. The guide does not announce release dates for its own revisions: the revision on sale is shown on this page.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv\u003e\u003ch3 style=\"font-size:22px;margin:0 0 6px 0;color:#1D1F1A\"\u003eThe 24 tools, in six groups\u003c\/h3\u003e\u003cp style=\"margin:0 0 18px 0;font-size:15px;color:#585B4E;max-width:720px\"\u003eOne folder per part of the book, with the exact titles of the English edition. \u003cstrong\u003eNo operational value is preloaded\u003c\/strong\u003e: flow, temperature and wavelength tolerances, carryover, %RSD, resolution, S\/N ratio, mass accuracy, blank limits, mechanical tolerances of dissolution apparatus, deaeration criteria, Karl Fischer titre and drift, electrode slope and offset, cell constant, calibration and requalification intervals, number of replicates and acceptance criteria remain \u0026lt;to be defined\u0026gt;, with the decision code.\u003c\/p\u003e\u003cdiv style=\"font-size:13px;font-weight:700;color:#56632B;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e01_Qualification_Lifecycle · Analytical Qualification and Reliability\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-01 · Instrument Inventory and Classification Register\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eInstruments and systems with a justified class, regimes, primary record, audit trail status, retirements, roles and boundaries with the sister guides; it does not classify on its own.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-02 · Analytical Instrument URS and Selection\/DQ Checklist\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eNumbered, verifiable requirements with the mandatory ones kept apart, selection and DQ checklists.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-03 · Instrument Bid Evaluation and TCO\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eExclusions, weighted scores, NPV, scenarios, firm and estimated items, non-monetary criteria; no winner indicated.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-04 · IQ\/OQ\/PQ Qualification Protocol and Report\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eIQ, OQ including software functions, PQ, deviations and release, with the results of the calculators; it does not validate the computerised system.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-05 · Calibration, Performance Verification, Maintenance and Periodic Review Planner\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eJustified due dates, as-found results, reference materials, events, changes, source review, checklist and question bank; no frequency preloaded.\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"font-size:13px;font-weight:700;color:#56632B;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e02_HPLC_UHPLC · HPLC \u0026amp; UHPLC\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-06 · HPLC\/UHPLC OQ\/PV Calculator\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eOQ and performance verification tests, delay volume included; it feeds the AN-TK-04 protocol.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-07 · Chromatographic System Suitability Calculator and Trending\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eSST parameters with a stated convention, trends with the user's rules, columns and mobile phases; it does not qualify the instrument.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-08 · HPLC-to-UHPLC Transfer Calculator (Scaling and Dwell Volume)\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eScaling, back-pressure, delay volume measured per system and systems allowed by name; it does not predict selectivity or classify the change.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-09 · HPLC\/UHPLC Troubleshooting Guide and Log\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eFrom containment to demonstrated cause, return to service and impact on results.\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"font-size:13px;font-weight:700;color:#56632B;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e03_GC_Headspace · GC \u0026amp; Headspace\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-10 · GC and Headspace Qualification Protocol\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eGases, IQ, inlet, oven, FID, headspace, software and in-use checks.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-11 · GC\/HS Performance Calculator\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eRepeatability, leak tightness, linear velocity, split, headspace sensitivity, traps and filters; partition coefficients are illustrative.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-12 · GC\/HS Troubleshooting Guide\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eFrom symptom to demonstrated cause, impact on results and return to service.\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"font-size:13px;font-weight:700;color:#56632B;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e04_Spectroscopy_MS · Spectroscopy, LC-MS \u0026amp; ICP-MS\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-13 · UV-Vis Qualification Calculator\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eQualification tests and cuvette checks, stray light and path length simulations.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-14 · FTIR\/Raman Qualification and Identity Library Verification Protocol\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eFTIR with ATR and Raman, identity library with threshold, challenge and maintenance; process applications excluded.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-15 · LC-MS Qualification and Contamination Control Plan\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eMass scale and mass accuracy, resolution, sensitivity; contamination, carryover and matrix effects; no impurity limits.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-16 · ICP-MS Performance Calculator\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eResolving power, tuning, blanks by type, recoveries, internal standard and vessels; elements and PDEs stay with the sister guide.\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"font-size:13px;font-weight:700;color:#56632B;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e05_Dissolution_Physical · Dissolution and Physical Testing\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-17 · Dissolution Apparatus Mechanical Qualification Calculator\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eMechanical measurements per vessel against the tolerances entered for the chosen approach, PVT log with no criteria reproduced.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-18 · Dissolution Test Execution Checklist\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eApparatus, medium and deaeration, sampling, filtration, automation and hand-over to phase I.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-19 · Disintegration, Friability and Breaking-Force Tester Qualification and Routine Check Protocol\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eQualification, routine checks, balances and compendial texts not yet applicable; criteria from the applicable chapters.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-20 · Phase I Investigation Form for Suspected Instrument Cause\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eHypotheses, discriminating tests, contemporaneous evidence and retrospective extension; laboratory QA closes phase I.\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"font-size:13px;font-weight:700;color:#56632B;letter-spacing:1px;text-transform:uppercase;margin:0 0 9px 0\"\u003e06_TOC_Physicochemical · TOC and Physicochemical Measurements\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:20px\"\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-21 · TOC System Suitability and Blank Calculator\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eResponse efficiency with and without the blank, vial lots, spreadsheet regression, TOC by difference; no residue limits.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#34382C;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-22 · Karl Fischer, pH and Conductivity Calculator\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eTitre, water content and drift; slope, offset, zero point and ATC; cell constant and compensation; no comparison with product specifications.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-23 · Karl Fischer Titrator Qualification Protocol\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eBurette, titre, generator, drift, recovery, linearity, oven and software; no OMCL values.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px\"\u003e\u003cspan style=\"display:inline-block;background:#56632B;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:5px\"\u003eAN-TK-24 · pH Meter and Conductivity Meter Verification Protocol\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#585B4E\"\u003eBuffers, slope and offset, response time, ATC; cell constant, standards, compensation and retrospective assessment.\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cp style=\"margin:0 0 28px 0;font-size:14px;color:#585B4E\"\u003eIn the ITA - Italiano variant the same 24 tools carry the titles of the Italian edition and the same codes AN-TK-01…24. Every tool also exists as a filled-in example on the Corvessa Pharma case, in the 07_Examples folder.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv\u003e\u003ch3 style=\"font-size:22px;margin:0 0 14px 0;color:#1D1F1A\"\u003eReady to use tomorrow morning\u003c\/h3\u003e\u003ctable style=\"width:100%;border-collapse:collapse;font-size:14.5px;margin-bottom:28px\"\u003e\u003ctr style=\"background:#1D1F1A;color:#fff\"\u003e\u003cth style=\"text-align:left;padding:11px 13px\"\u003eThe situation\u003c\/th\u003e\u003cth style=\"text-align:left;padding:11px 13px\"\u003eWhat you use\u003c\/th\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top;width:38%\"\u003eA new UHPLC to specify, select and qualify\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top\"\u003eChapters 3, 5 and 6 + AN-TK-02, AN-TK-03, AN-TK-04 and AN-TK-06: URS with the mandatory requirements kept apart, bid evaluation and TCO, OQ with the delay volume measured on the installed configuration. It is the path of Case A, with the TCO in Chapter 3.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top;width:38%\"\u003eA gradient method moved to another system loses resolution of the critical pair\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top\"\u003eChapter 7 + AN-TK-07 and AN-TK-08: delay volume measured per system, injection delay correction, systems allowed by name, S\/N convention aligned with that of the validated method. It is Case A.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top;width:38%\"\u003eHeadspace area repeatability gets worse sequence after sequence\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top\"\u003eChapters 11 and 12 + AN-TK-11, AN-TK-12 and AN-TK-05: variables fixed in the method, crimp check, trend rule and impact assessment on the sequences of the period. It is Case B.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top;width:38%\"\u003eAn ICP-MS signal without the analyte, or high digestion blanks\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top\"\u003eChapter 16 + AN-TK-16: cell mode, chloride check solution in every sequence, dedicated vessel sets and a check blank before reuse. It is Case C.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top;width:38%\"\u003eA dissolution OOS with bubbles on shaft, paddle and tablets\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top\"\u003eChapters 17, 18 and 20 + AN-TK-17, AN-TK-18 and AN-TK-20: calibration approach, deaeration and storage of the medium, contemporaneous evidence, retrospective extension and return to service. It is Case D.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top;width:38%\"\u003eA TOC response efficiency that looks perfect, with a high blank in the raw data\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top\"\u003eChapter 21 + AN-TK-21: reagent water blank, certificate and incoming blank for every vial lot, regression of the spreadsheet on every term. It is Case E.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top;width:38%\"\u003eAn out-of-tolerance as-found result at periodic calibration\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top\"\u003eChapter 4 + AN-TK-05 and AN-TK-20: suspect period back to the last valid calibration, retrospective assessment of reported results, intervals revised on the observed drift.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top;width:38%\"\u003eA GMP inspection with the QC laboratory in scope\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #DCDECF;vertical-align:top\"\u003eChapters 1, 2 and 4 + AN-TK-01 and AN-TK-05: inventory and justified classes, audit trail status, programme with justified due dates, source review and 159 inspector questions built for training.\u003c\/td\u003e\u003c\/tr\u003e\u003c\/table\u003e\u003c\/div\u003e\u003cdiv style=\"background:#F5F6EE;border-left:4px solid #C3D432;border-radius:0 9px 9px 0;padding:20px 22px 9px 22px;margin-bottom:28px\"\u003e\u003cdiv style=\"font-weight:700;color:#1D1F1A;font-size:16px;margin-bottom:11px\"\u003eWhat the guide does not do\u003c\/div\u003e\u003cdiv style=\"font-size:14.5px;color:#26291F\"\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#56632B\"\u003eIt gives no universal numbers.\u003c\/strong\u003e No universal values for instrument tolerances, carryover, %RSD, resolution, S\/N, system suitability criteria, calibration and requalification frequencies or number of replicates. Where a source states a value, the guide reports it with document, clause, nature and object; numerical examples are marked [DEMONSTRATION EXAMPLE].\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#56632B\"\u003eIt never declares an instrument qualified or a result valid.\u003c\/strong\u003e No tool in the toolkit returns a \"qualified\" or \"fit\" outcome: the only outcomes are \"Comparison with the entered criteria\" or \"Assessment required\", and missing data always lead to the latter. The decision on the status of the instrument rests with the quality function, on the basis of data and a documented assessment; a qualified instrument does not mean a valid result.\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#56632B\"\u003eIt does not duplicate the sister guides.\u003c\/strong\u003e Method development and validation are in \u003ca href=\"https:\/\/www.guidegxp.com\/products\/quality-guidelines-ich-q-guida-completa-q8-q9-q10-q12-e-nuovo-q1\" style=\"color:#56632B;font-weight:700\"\u003e\"ICH Q Quality Guidelines: what is actually applicable, and readiness for the new Q1\"\u003c\/a\u003e; the chain of compendial obligation in \u003ca href=\"https:\/\/www.guidegxp.com\/products\/farmacopee-gmp-guida-operativa-usp-ph-eur\" style=\"color:#56632B;font-weight:700\"\u003e\"Pharmacopoeias in GMP – Operational Guide to USP, Ph. Eur., JP and BP (First Edition + Toolkit)\"\u003c\/a\u003e; audit trail review, data governance and CDS in \u003ca href=\"https:\/\/www.guidegxp.com\/products\/data-integrity-gmp-guida-operativa-audit-trail-review\" style=\"color:#56632B;font-weight:700\"\u003e\"Data Integrity in GMP – Operational Guide to Governance, Audit Trail Review and QC Laboratories\"\u003c\/a\u003e; the validation lifecycle of computerised systems in the \u003ca href=\"https:\/\/www.guidegxp.com\/products\/guida-operativa-alla-computer-system-validation-csv-in-ambito-gxp\" style=\"color:#56632B;font-weight:700\"\u003e\"Operational Guide to Computer System Validation (CSV) in the GxP Environment\"\u003c\/a\u003e; risk assessment, limits and PDEs for elemental impurities and nitrosamines in \u003ca href=\"https:\/\/www.guidegxp.com\/products\/ich-q3d-m7-impurezze-elementari-nitrosammine-guida\" style=\"color:#56632B;font-weight:700\"\u003e\"Elemental, Mutagenic and Nitrosamine Impurities: Risk Assessment under ICH Q3D and M7\"\u003c\/a\u003e. This guide describes only how the instrument connects to those requirements.\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#56632B\"\u003eIt is not legal advice and does not reproduce subscription texts.\u003c\/strong\u003e It describes the texts, status and force of the sources. USP–NF, Ph. Eur., JP, ISO, ASTM and ISPE are cited by title, number, edition and status, with no tables or numerical criteria; the OMCL guidelines by structure and parameters, with no limits.\u003c\/p\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv\u003e\u003ch3 style=\"font-size:22px;margin:0 0 6px 0;color:#1D1F1A\"\u003eContents: six parts, 24 chapters\u003c\/h3\u003e\u003cp style=\"margin:0 0 14px 0;font-size:15px;color:#585B4E;max-width:720px\"\u003eChapter titles of the English edition. Every chapter closes with a checklist, related tools and articles, decisions and the chapter's sources.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:14px\"\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:7px\"\u003ePart I — Analytical Qualification and Reliability\u003c\/div\u003e\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#26291F\"\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e1.\u003c\/span\u003e Regulatory basis, responsibilities and governance of laboratory instrumentation\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e2.\u003c\/span\u003e Analytical instrument qualification: lifecycle, classification and software\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e3.\u003c\/span\u003e Requirements, selection, supplier, DQ and TCO\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e4.\u003c\/span\u003e Operating the instrument fleet: calibration, performance verification, maintenance, failures, change control, requalification, periodic review and retirement\u003c\/li\u003e\u003c\/ol\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:7px\"\u003ePart II — HPLC \u0026amp; UHPLC\u003c\/div\u003e\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#26291F\"\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e5.\u003c\/span\u003e HPLC\/UHPLC architecture, platform selection and URS for modules and software\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e6.\u003c\/span\u003e HPLC\/UHPLC qualification and calibration (flow, gradient, injection, temperature, detector, carryover)\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e7.\u003c\/span\u003e Columns, mobile phase, system suitability and HPLC→UHPLC transfer\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e8.\u003c\/span\u003e HPLC\/UHPLC troubleshooting and maintenance (pressure, peak shape, baseline, carryover, return to service)\u003c\/li\u003e\u003c\/ol\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:7px\"\u003ePart III — GC \u0026amp; Headspace\u003c\/div\u003e\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#26291F\"\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e9.\u003c\/span\u003e GC systems: inlets, detectors, gases and point-of-use control\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e10.\u003c\/span\u003e GC qualification and performance checks\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e11.\u003c\/span\u003e Headspace GC: equilibration, sampling and reproducibility\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e12.\u003c\/span\u003e GC\/HS troubleshooting and maintenance (leaks, peaks, retention)\u003c\/li\u003e\u003c\/ol\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:7px\"\u003ePart IV — Spectroscopy, LC-MS \u0026amp; ICP-MS\u003c\/div\u003e\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#26291F\"\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e13.\u003c\/span\u003e UV-Vis: qualification and problems (wavelength, photometry, stray light, cuvettes, baseline)\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e14.\u003c\/span\u003e FTIR and Raman: qualification, performance verification and identity\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e15.\u003c\/span\u003e LC-MS in QC: requirements, qualification, contamination and matrix effects\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e16.\u003c\/span\u003e ICP-MS (and ICP-OES) in QC: qualification, blanks and interferences\u003c\/li\u003e\u003c\/ol\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:7px\"\u003ePart V — Dissolution and Physical Testing\u003c\/div\u003e\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#26291F\"\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e17.\u003c\/span\u003e Dissolution apparatus: mechanical qualification and performance verification\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e18.\u003c\/span\u003e Dissolution testing: medium, deaeration, temperature, sampling and automation\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e19.\u003c\/span\u003e Disintegration, friability and breaking force\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e20.\u003c\/span\u003e Abnormal results with a possible instrument cause: phase I investigation, OOS and return to service\u003c\/li\u003e\u003c\/ol\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 300px;background:#FFFFFF;border:1px solid #DCDECF;border-radius:10px;padding:15px 17px\"\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#1D1F1A;margin-bottom:7px\"\u003ePart VI — TOC and Physicochemical Measurements\u003c\/div\u003e\u003col style=\"margin:0;padding-left:0;list-style:none;font-size:14px;color:#26291F\"\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e21.\u003c\/span\u003e Laboratory TOC: technologies, calibration, system suitability and problems\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e22.\u003c\/span\u003e Volumetric and coulometric Karl Fischer titration\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e23.\u003c\/span\u003e pH measurement\u003c\/li\u003e\u003cli style=\"margin:0 0 4px 0\"\u003e\u003cspan style=\"color:#56632B;font-weight:700\"\u003e24.\u003c\/span\u003e Conductivity measurement\u003c\/li\u003e\u003c\/ol\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cp style=\"margin:0 0 28px 0;font-size:14.5px;color:#26291F\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003eAppendices A–F.\u003c\/strong\u003e A ITA\/ENG glossary · B Source matrix · C Chapter, toolkit and article matrix · D Toolkit instructions · E Register of assumptions and limitations · F Revision and change log.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv\u003e\u003ch3 style=\"font-size:22px;margin:0 0 6px 0;color:#1D1F1A\"\u003eWhat the package contains\u003c\/h3\u003e\u003cp style=\"margin:0 0 12px 0;font-size:15px;color:#585B4E;max-width:720px\"\u003eAfter payment you download a ZIP file with the guide and the toolkit in the language of the chosen variant.\u003c\/p\u003e\u003cul style=\"margin:0 0 28px 0;padding-left:20px;font-size:15px;color:#26291F\"\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003eThe complete PDF guide.\u003c\/strong\u003e 309 A4 pages in the Italian edition, 308 in the English one; clickable table of contents and bookmarks.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003e24 editable tools.\u003c\/strong\u003e 12 Word templates and 12 Excel workbooks, in the folders 01_Qualification_Lifecycle…06_TOC_Physicochemical.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003e24 filled-in examples and demonstration datasets.\u003c\/strong\u003e The examples on the Corvessa Pharma case in the 07_Examples folder, with the datasets DS-01…DS-12 (instrument register, UHPLC transfer and TCO, headspace, ICP-MS, TOC, physicochemical measurements, OQ and performance verifications, dissolution mechanics, test cases) in .csv and .xlsx.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003eSupport files.\u003c\/strong\u003e README, toolkit index, field glossary and chapter–toolkit–article matrix in the 00_Read_Me folder.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003eVerification.\u003c\/strong\u003e Test Log with one row per tool, test case and file, language parity report, check of example values and a manifest with the SHA-256 hash of every file, in the 08_Verification folder.\u003c\/li\u003e\u003c\/ul\u003e\u003c\/div\u003e\u003cdiv style=\"background:#F5F6EE;border:1px solid #DCDECF;border-radius:12px;padding:22px 24px;margin-bottom:28px\"\u003e\u003ch3 style=\"font-size:22px;margin:0 0 8px 0;color:#1D1F1A\"\u003eRead the excerpt before you buy\u003c\/h3\u003e\u003cp style=\"margin:0 0 16px 0;font-size:15px;color:#585B4E;max-width:720px\"\u003eThe free excerpt is made of real pages: 15 pages in the Italian edition, 15 in the English one. It contains the presentation with the regulatory status box and the labels, the full table of contents, from Chapter 2 the problem and the decision, layered data quality and the errors to avoid, from Chapter 7 the HPLC→UHPLC transfer with the gradient delay volume and the complete Case A, real pages of three tools (AN-TK-07, AN-TK-08 and AN-TK-20) and the list of what the purchase includes.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:10px\"\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Analytical_Instrumentation_Preview_IT_v1.0.pdf?v=1790985856\" target=\"_blank\" rel=\"noopener\" hreflang=\"it\" style=\"display:inline-block;background:#1D1F1A;color:#ffffff;font-weight:700;font-size:15px;text-decoration:none;padding:12px 22px;border-radius:6px\"\u003eFree excerpt — Italian edition (PDF)\u003c\/a\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Analytical_Instrumentation_Preview_EN_v1.0.pdf?v=1790985857\" target=\"_blank\" rel=\"noopener\" hreflang=\"en\" style=\"display:inline-block;background:#ffffff;color:#1D1F1A;border:1.5px solid #1D1F1A;font-weight:700;font-size:15px;text-decoration:none;padding:11px 21px;border-radius:6px\"\u003eFree excerpt — English edition (PDF)\u003c\/a\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv\u003e\u003ch3 style=\"font-size:22px;margin:0 0 14px 0;color:#1D1F1A\"\u003eSpecifications\u003c\/h3\u003e\u003ctable style=\"width:100%;border-collapse:collapse;font-size:14.5px;margin-bottom:24px\"\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eFormat\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003eA4 PDF with clickable table of contents and bookmarks; tools in .docx and .xlsx\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003ePages and chapters\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003e309 pages (ITA edition) · 308 pages (ENG edition) · 24 chapters in six parts + 6 appendices (A–F)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eToolkit\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003e24 editable tools: 12 Word + 12 Excel, codes AN-TK-01…24, plus 24 filled-in examples\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eFile languages\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003eOne language per purchase: \u003cstrong\u003eITA - Italiano\u003c\/strong\u003e or \u003cstrong\u003eENG - English\u003c\/strong\u003e. There are no files in French, German or Spanish.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eEdition and revision\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003eFirst edition, October 2026 · v1.0 · tools rev. 1.0\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eRegulatory verification\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003e02\/10\/2026 (status of every source as of that date)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eReferences\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003eEU (EudraLex, EMA) · PIC\/S · WHO · ICH · USA (21 CFR, FDA guidance) · United Kingdom (essential status) · USP–NF, Ph. Eur. and JP (texts not reproduced) · OMCL network · metrology and voluntary technical standards\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eSources and decisions\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003e121 sources in the Appendix B register · 106 decisions tracked in Appendix D\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eFree excerpt\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003e15 pages (ITA edition) · 15 pages (ENG edition)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eUpdates\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003eWhen the texts change, you receive the revised guide and toolkit at no extra cost.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eDelivery\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003eDigital product: download of the ZIP file after payment. No shipping: the 3D image of the volume is a graphic rendering; there is no printed book.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eSoftware requirements\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003eA PDF reader; Microsoft Word and Excel or compatible programs: the Excel workbooks were recalculated with LibreOffice in the Test Log runs. No macros, no external links; calculated cells protected without a password.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F6EE\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003eLicence\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003eIndividual use and internal use within the purchasing company: a personal, non-exclusive, non-transferable licence under the site's Legal Notice; printing for internal use only; sharing the files with third parties is prohibited.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF;width:32%;font-weight:600;color:#1D1F1A;vertical-align:top\"\u003ePrice\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #DCDECF\"\u003e€199.00 per variant (guide + toolkit in the chosen language)\u003c\/td\u003e\u003c\/tr\u003e\u003c\/table\u003e\u003c\/div\u003e\u003cdiv style=\"background:#FFFFFF;border:1px solid #DCDECF;border-left:4px solid #1D1F1A;border-radius:0 11px 11px 0;padding:18px 22px 6px 22px;margin-bottom:28px\"\u003e\u003cdiv style=\"font-weight:700;color:#1D1F1A;font-size:16px;margin-bottom:10px\"\u003eLimits of use\u003c\/div\u003e\u003cul style=\"margin:0 0 10px 0;padding-left:20px;font-size:15px;color:#26291F\"\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eThe Excel workbooks are calculation templates with specification, tests and limits, \u003cstrong\u003enot validated software\u003c\/strong\u003e: before GMP use, the laboratory verifies them in its own quality system by repeating the relevant Test Log cases.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eSimulated case: Corvessa Pharma S.p.A. is a fictitious company; its QC laboratory and the data are hypothetical. Example values are not acceptance criteria or parameters of a real instrument.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eNo sheet declares an instrument qualified or a result valid: the only outcomes are \"Comparison with the entered criteria\" or \"Assessment required\". The guide does not replace the assessment of the quality function.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eThe guide does not replace the official texts cited and is not personalised legal, regulatory or quality advice.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eThe inspector questions are built for training and do not reproduce real findings; the ten FDA Warning Letters cited are verified, anonymised and each illustrates one topic. No guarantee of audit or inspection outcomes, which depend on context and application.\u003c\/li\u003e\u003cli style=\"margin:0 0 8px 0\"\u003eThe numerical examples were recalculated independently by the editorial team; the guide and the toolkit have not undergone independent third-party validation.\u003c\/li\u003e\u003c\/ul\u003e\u003c\/div\u003e\u003cdiv style=\"background:#F5F6EE;border:1px solid #DCDECF;border-radius:11px;padding:18px 21px;margin-bottom:28px;font-size:14.5px;color:#26291F\"\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003eWho it is for.\u003c\/strong\u003e QC managers and analysts, laboratory QA, laboratory CQV and validation, metrology and calibration, laboratory IT\/CSV, procurement, suppliers and service engineers. It is written for those who \u003cstrong\u003eselect, qualify, verify, repair or govern QC laboratory instruments\u003c\/strong\u003e: HPLC and UHPLC, GC and headspace, UV-Vis, FTIR and Raman, LC-MS, ICP-MS and ICP-OES, dissolution apparatus, disintegration, friability and breaking-force testers, TOC analysers, Karl Fischer titrators, pH meters and conductivity meters, and need to know which text every value comes from, with what force and in which jurisdiction.\u003c\/p\u003e\u003cp style=\"margin:0\"\u003e\u003cstrong style=\"color:#1D1F1A\"\u003eWho it is not for.\u003c\/strong\u003e It is not a guide to method validation, data integrity and audit trail review, computerised system validation or impurity risk assessment (the subjects of the sister guides linked on this page), nor to online TOC and conductivity in water systems, extractables and leachables studies or OOS as a general quality process. Stability chambers, microbiology laboratory instruments and process (PAT) applications of NIR and Raman are out of scope; polarimeters, refractometers, viscometers and the other instruments outside the six families follow the general principles of Chapters 1–4.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv\u003e\u003ch3 style=\"font-size:22px;margin:0 0 12px 0;color:#1D1F1A\"\u003eFrequently asked questions\u003c\/h3\u003e\u003cdiv style=\"margin-bottom:28px\"\u003e\u003cdiv style=\"border-bottom:1px solid #DCDECF;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#1D1F1A\"\u003eWhich language are the files in?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#26291F\"\u003eThe language of the chosen variant: \u003cstrong\u003eITA - Italiano\u003c\/strong\u003e or \u003cstrong\u003eENG - English\u003c\/strong\u003e. Each purchase includes the guide and the toolkit in one language. There are no files in French, German or Spanish.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"border-bottom:1px solid #DCDECF;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#1D1F1A\"\u003eIs it a printed book?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#26291F\"\u003eNo. It is a digital product: after payment you download a ZIP file with the PDF and the tools. No shipping; the 3D image is only a rendering of the volume.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"border-bottom:1px solid #DCDECF;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#1D1F1A\"\u003eDoes the guide give tolerances, %RSD or calibration frequencies that apply to everyone?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#26291F\"\u003eNo, because no regulation sets them. It reports the values the sources state, with their nature (\"a common frequency is once a year\" is an example from the FDA Q\u0026amp;A for the balance auto-calibrator, 60% saturation of dissolved gases a recommendation of the January 2010 FDA guidance, 2%\/°C a convention for dilute salt solutions), and the method for deciding the laboratory's own, each with its decision code (Chapters 4, 18 and 24).\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"border-bottom:1px solid #DCDECF;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#1D1F1A\"\u003eDo the tools say whether an instrument is qualified or a result is valid?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#26291F\"\u003eNo. They return only \"Comparison with the entered criteria\" or \"Assessment required\"; missing data, exceedances or criteria not entered always lead to the latter, with the reason. The decision rests with the quality function.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"border-bottom:1px solid #DCDECF;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#1D1F1A\"\u003eDoes it reproduce USP and Ph. Eur. criteria and tables?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#26291F\"\u003eNo. Compendial texts are sold by subscription: the guide reports their number, title, edition and status and describes the structure of the decision; for requirements, methods and criteria the current text prevails. The chain of compendial obligation is covered by the sister guide on pharmacopoeias linked on this page.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"border-bottom:1px solid #DCDECF;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#1D1F1A\"\u003eDoes it take the revision of USP 〈1058〉 into account?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#26291F\"\u003eYes, as a proposal: the official text remains the one official since 01\/08\/2017, and the revision published in the Pharmacopeial Forum is a draft [DRAFT] that the guide does not treat as a requirement. Its final text is one of the re-verification events in Appendix F (Chapters 1–2).\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"border-bottom:1px solid #DCDECF;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#1D1F1A\"\u003eDoes it apply to the United States?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#26291F\"\u003eThe main reference is the EU, with PIC\/S and WHO as guidance; for the United States the guide covers 21 CFR 211 (calibration in 211.160(b)(4), equipment in 211.63 and 211.68) and Part 11, the relevant FDA guidance (OOS, mechanical calibration of dissolution apparatus, data integrity), the Q\u0026amp;A on laboratory controls and informational USP chapters such as 〈1058〉, which set no requirements, without reproducing their text.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"border-bottom:1px solid #DCDECF;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#1D1F1A\"\u003eAre the Excel workbooks validated?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#26291F\"\u003eThey are not validated software. Each one has a Read_Me with inputs, calculations, checks and limits, readable formulas, error checks and a Test Log of the tests run: the laboratory verifies them in its own system before GMP use.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"border-bottom:1px solid #DCDECF;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#1D1F1A\"\u003eWhat happens when the reference texts change?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#26291F\"\u003eAppendix F lists the events that trigger re-verification of the guide: final texts of the Annex 11, Chapter 4 and Chapter 1 revisions, the draft revision of Annex 15, the revision of USP 〈1058〉, Ph. Eur. Issues 13.1 and 13.2, new USP–NF Issues. When the texts change, you receive the revised guide and toolkit at no extra cost. The revision on sale is shown on this page, with the regulatory verification date.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"border-bottom:1px solid #DCDECF;padding:13px 0\"\u003e\u003cp style=\"margin:0 0 6px 0;font-weight:700;font-size:15px;color:#1D1F1A\"\u003eCan I share the files with colleagues, suppliers or service engineers?\u003c\/p\u003e\u003cp style=\"margin:0;font-size:14.5px;color:#26291F\"\u003eThe licence is for individual use and internal use within the purchasing company, personal, non-exclusive and non-transferable: sharing the files with third parties, including suppliers, service engineers and external consultants, is prohibited. Printing is allowed for internal use only.\u003c\/p\u003e\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"background:#F5F6EE;border:1px solid #DCDECF;border-radius:12px;padding:20px 24px;margin-bottom:16px\"\u003e\u003cdiv style=\"font-size:17px;font-weight:700;color:#1D1F1A;margin-bottom:6px\"\u003eBefore you buy: the Analytical Instrumentation hub\u003c\/div\u003e\u003cp style=\"margin:0 0 12px 0;font-size:15px;color:#26291F\"\u003eThe 37 technical articles of the Analytical Instrumentation hub introduce the six areas of the guide, from instrument qualification under USP 〈1058〉 to conductivity measurement.\u003c\/p\u003e\u003ca href=\"https:\/\/www.guidegxp.com\/pages\/pharma-lab-analytical-instrumentation\" style=\"color:#56632B;font-weight:700;font-size:15px\"\u003eGo to the Analytical Instrumentation hub →\u003c\/a\u003e\u003c\/div\u003e\u003cdiv style=\"background:#1D1F1A;border-radius:12px;padding:24px 26px;color:#fff;margin-bottom:20px\"\u003e\u003cdiv style=\"font-size:18px;font-weight:700;margin-bottom:8px;color:#ffffff\"\u003eDo you have an instrument to qualify, an open investigation or an instrument fleet to bring back under control?\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#E3E4DB;margin-bottom:16px;max-width:660px\"\u003eDescribe the instrument, its intended use, the stage (purchase, qualification, routine operation or investigation) and where you are stuck. GuideGxP will review the request and, where appropriate, may put you in touch with a specialist suited to your technical needs and your geographical area.\u003c\/div\u003e\u003ca href=\"https:\/\/www.guidegxp.com\/pages\/expert-support?area=lab-analytical-instrumentation\u0026amp;source=product-analytical-instrumentation-gmp-qc-laboratory-guide\u0026amp;cta=product-page\" style=\"display:inline-block;background:#C3D432;color:#1D1F1A;font-weight:700;font-size:15px;text-decoration:none;padding:11px 22px;border-radius:6px\"\u003eDescribe your situation →\u003c\/a\u003e\u003cdiv style=\"font-size:12.5px;color:#E3E4DB;margin-top:12px\"\u003eNo purchase obligation. The request is reviewed before any referral to a specialist.\u003c\/div\u003e\u003c\/div\u003e\u003cp style=\"font-size:12.5px;color:#585B4E;margin:0\"\u003eGuideGxP guides do not replace official legislation or the guidance and standards cited (European Commission, EMA, PIC\/S, WHO, ICH, FDA, MHRA, EDQM, OMCL network, USP, PMDA, ISO, ASTM, NIST, ISPE): they are operational support tools, do not constitute legal advice, and users remain responsible for the correct application of the rules in force in their own company context. Subscription texts are not reproduced. Numerical examples are for demonstration and are not acceptance criteria; the decision on the status of an instrument and on the validity of a result rests with the quality function. Regulatory status verified as of 02\/10\/2026. Corvessa Pharma S.p.A. is a fictitious company. Digital product: no physical shipping.\u003c\/p\u003e\u003c\/div\u003e","brand":"GuideGxP","offers":[{"title":"ITA - Italiano","offer_id":63782398329162,"sku":null,"price":199.0,"currency_code":"EUR","in_stock":true},{"title":"ENG - English","offer_id":63782398361930,"sku":null,"price":199.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/00_cover_en_3D.png?v=1791020096","url":"https:\/\/www.guidegxp.com\/products\/analytical-instrumentation-gmp-qc-laboratory-guide","provider":"GuideGxP","version":"1.0","type":"link"}