First edition · v1.0 · regulatory verification 02/10/2026
System 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.
A 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. 24 chapters in six parts and 6 appendices, 309 pages in the Italian edition and 308 in the English one, and 24 editable tools in Word and Excel, for €199.
309 pages (ITA) · 308 (ENG) · PDF A424 chapters in six parts + 6 appendices24 tools: 12 Word + 12 Excel121 sources in the register106 tracked decisionsDigital product: download after payment
One language per purchase, chosen by the variant. The ITA - Italiano variant gives you the PDF guide and the 24 tools in Italian; the ENG - English 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.
The decisions it helps you make
Every 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.
Programme, classes and release for use
Programme 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.
Chapters 1–2 · AN-TK-01, AN-TK-04
URS, bids and TCO
Numbered, 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.
Chapter 3 · AN-TK-02, AN-TK-03
Intervals, as-found results and suspect periods
Calibration 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.
Chapter 4 · AN-TK-05
HPLC/UHPLC OQ and performance verification
Flow, gradient, injection, temperature, detector and carryover with stated criteria and calculation conventions; gradient delay volume measured on the installed configuration.
Chapters 5–6 · AN-TK-06, AN-TK-04
System suitability and method transfer
When 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.
Chapter 7 · AN-TK-07, AN-TK-08
Troubleshooting and return to service
From 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.
Chapters 8 and 12 · AN-TK-09, AN-TK-12
GC and headspace
Gases 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.
Chapters 9–11 · AN-TK-10, AN-TK-11
UV-Vis, FTIR and Raman
Reference materials and certificate conditions, maximum absorbance allowed for each method, cuvettes, wavenumber axis and Raman shift, threshold and challenge of the identity library.
Chapters 13–14 · AN-TK-13, AN-TK-14
LC-MS and ICP-MS
Mass accuracy convention, contamination, carryover and matrix effects; cell mode, blanks by type, digestion vessels, tuning and recoveries.
Chapters 15–16 · AN-TK-15, AN-TK-16
Dissolution apparatus and physical tests
Enhanced mechanical calibration, PVT or both, with tolerances from the chosen text; deaeration, dispensing and storage of the medium; disintegration, friability and breaking-force testers.
Chapters 17–19 · AN-TK-17, AN-TK-18, AN-TK-19
Phase I investigation
When 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.
Chapter 20 · AN-TK-20
TOC, Karl Fischer, pH and conductivity
Response efficiency with the blank and vial lots; Karl Fischer titre and drift; buffers, slope and offset; cell constant and stated temperature compensation.
Chapters 21–24 · AN-TK-21…24
The myths it takes apart
Statements that circulate as "requirements" and that the sources write differently. For each one the guide gives the document, clause, nature and object.
"System suitability replaces qualification." 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).
"The supplier's IQ/OQ package qualifies the instrument." 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).
"USP 〈1058〉 is mandatory, and the new version is already in force." 〈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).
"The regulations say how often to calibrate and requalify." 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&A on laboratory controls for the balance auto-calibrator, not a general rule (Chapter 4).
"OMCL limits are GMP requirements." 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).
"An HPLC's delay volume is the typical catalogue figure." 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).
"FDA withdrew the mechanical calibration guidance, and PVT twice a year is a requirement." 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).
"An OOS is invalidated for an instrument problem by repeating the analysis." 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).
The guide
24 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: requirement → interpretation → risk → decision → action → evidence → audit readiness. Four status labels and seven nature labels tell you what each source is worth and in which jurisdiction.
The toolkit
24 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".
Five integrated cases
In 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.
Regulatory status verified as of 02/10/2026
The guide describes the regulatory and technical framework as of 02/10/2026; 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:
- USP 〈1058〉 'Analytical Instrument Qualification': 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.
- WHO TRS 1052, Annex 4 'WHO good practices for pharmaceutical quality control laboratories' (2024) is current and supersedes TRS 957, Annex 1 (2010).
- Annex 11, Chapter 4 and Chapter 1: 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.
- ICH Q2(R2) and ICH Q14 (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.
- Dissolution apparatus: 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.
- Pharmacopoeias: 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.
- OMCL: 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.
Updates included. 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.
The 24 tools, in six groups
One folder per part of the book, with the exact titles of the English edition. No operational value is preloaded: 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 <to be defined>, with the decision code.
01_Qualification_Lifecycle · Analytical Qualification and Reliability
EXCELAN-TK-01 · Instrument Inventory and Classification Register
Instruments 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.
WORDAN-TK-02 · Analytical Instrument URS and Selection/DQ Checklist
Numbered, verifiable requirements with the mandatory ones kept apart, selection and DQ checklists.
EXCELAN-TK-03 · Instrument Bid Evaluation and TCO
Exclusions, weighted scores, NPV, scenarios, firm and estimated items, non-monetary criteria; no winner indicated.
WORDAN-TK-04 · IQ/OQ/PQ Qualification Protocol and Report
IQ, OQ including software functions, PQ, deviations and release, with the results of the calculators; it does not validate the computerised system.
EXCELAN-TK-05 · Calibration, Performance Verification, Maintenance and Periodic Review Planner
Justified due dates, as-found results, reference materials, events, changes, source review, checklist and question bank; no frequency preloaded.
02_HPLC_UHPLC · HPLC & UHPLC
EXCELAN-TK-06 · HPLC/UHPLC OQ/PV Calculator
OQ and performance verification tests, delay volume included; it feeds the AN-TK-04 protocol.
EXCELAN-TK-07 · Chromatographic System Suitability Calculator and Trending
SST parameters with a stated convention, trends with the user's rules, columns and mobile phases; it does not qualify the instrument.
EXCELAN-TK-08 · HPLC-to-UHPLC Transfer Calculator (Scaling and Dwell Volume)
Scaling, back-pressure, delay volume measured per system and systems allowed by name; it does not predict selectivity or classify the change.
WORDAN-TK-09 · HPLC/UHPLC Troubleshooting Guide and Log
From containment to demonstrated cause, return to service and impact on results.
03_GC_Headspace · GC & Headspace
WORDAN-TK-10 · GC and Headspace Qualification Protocol
Gases, IQ, inlet, oven, FID, headspace, software and in-use checks.
EXCELAN-TK-11 · GC/HS Performance Calculator
Repeatability, leak tightness, linear velocity, split, headspace sensitivity, traps and filters; partition coefficients are illustrative.
WORDAN-TK-12 · GC/HS Troubleshooting Guide
From symptom to demonstrated cause, impact on results and return to service.
04_Spectroscopy_MS · Spectroscopy, LC-MS & ICP-MS
EXCELAN-TK-13 · UV-Vis Qualification Calculator
Qualification tests and cuvette checks, stray light and path length simulations.
WORDAN-TK-14 · FTIR/Raman Qualification and Identity Library Verification Protocol
FTIR with ATR and Raman, identity library with threshold, challenge and maintenance; process applications excluded.
WORDAN-TK-15 · LC-MS Qualification and Contamination Control Plan
Mass scale and mass accuracy, resolution, sensitivity; contamination, carryover and matrix effects; no impurity limits.
EXCELAN-TK-16 · ICP-MS Performance Calculator
Resolving power, tuning, blanks by type, recoveries, internal standard and vessels; elements and PDEs stay with the sister guide.
05_Dissolution_Physical · Dissolution and Physical Testing
EXCELAN-TK-17 · Dissolution Apparatus Mechanical Qualification Calculator
Mechanical measurements per vessel against the tolerances entered for the chosen approach, PVT log with no criteria reproduced.
WORDAN-TK-18 · Dissolution Test Execution Checklist
Apparatus, medium and deaeration, sampling, filtration, automation and hand-over to phase I.
WORDAN-TK-19 · Disintegration, Friability and Breaking-Force Tester Qualification and Routine Check Protocol
Qualification, routine checks, balances and compendial texts not yet applicable; criteria from the applicable chapters.
WORDAN-TK-20 · Phase I Investigation Form for Suspected Instrument Cause
Hypotheses, discriminating tests, contemporaneous evidence and retrospective extension; laboratory QA closes phase I.
06_TOC_Physicochemical · TOC and Physicochemical Measurements
EXCELAN-TK-21 · TOC System Suitability and Blank Calculator
Response efficiency with and without the blank, vial lots, spreadsheet regression, TOC by difference; no residue limits.
EXCELAN-TK-22 · Karl Fischer, pH and Conductivity Calculator
Titre, water content and drift; slope, offset, zero point and ATC; cell constant and compensation; no comparison with product specifications.
WORDAN-TK-23 · Karl Fischer Titrator Qualification Protocol
Burette, titre, generator, drift, recovery, linearity, oven and software; no OMCL values.
WORDAN-TK-24 · pH Meter and Conductivity Meter Verification Protocol
Buffers, slope and offset, response time, ATC; cell constant, standards, compensation and retrospective assessment.
In 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.
Ready to use tomorrow morning
| The situation | What you use |
|---|
| A new UHPLC to specify, select and qualify | Chapters 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. |
| A gradient method moved to another system loses resolution of the critical pair | Chapter 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. |
| Headspace area repeatability gets worse sequence after sequence | Chapters 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. |
| An ICP-MS signal without the analyte, or high digestion blanks | Chapter 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. |
| A dissolution OOS with bubbles on shaft, paddle and tablets | Chapters 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. |
| A TOC response efficiency that looks perfect, with a high blank in the raw data | Chapter 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. |
| An out-of-tolerance as-found result at periodic calibration | Chapter 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. |
| A GMP inspection with the QC laboratory in scope | Chapters 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. |
What the guide does not do
It gives no universal numbers. 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].
It never declares an instrument qualified or a result valid. 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.
It does not duplicate the sister guides. Method development and validation are in "ICH Q Quality Guidelines: what is actually applicable, and readiness for the new Q1"; the chain of compendial obligation in "Pharmacopoeias in GMP – Operational Guide to USP, Ph. Eur., JP and BP (First Edition + Toolkit)"; audit trail review, data governance and CDS in "Data Integrity in GMP – Operational Guide to Governance, Audit Trail Review and QC Laboratories"; the validation lifecycle of computerised systems in the "Operational Guide to Computer System Validation (CSV) in the GxP Environment"; risk assessment, limits and PDEs for elemental impurities and nitrosamines in "Elemental, Mutagenic and Nitrosamine Impurities: Risk Assessment under ICH Q3D and M7". This guide describes only how the instrument connects to those requirements.
It is not legal advice and does not reproduce subscription texts. 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.
Contents: six parts, 24 chapters
Chapter titles of the English edition. Every chapter closes with a checklist, related tools and articles, decisions and the chapter's sources.
Part I — Analytical Qualification and Reliability
- 1. Regulatory basis, responsibilities and governance of laboratory instrumentation
- 2. Analytical instrument qualification: lifecycle, classification and software
- 3. Requirements, selection, supplier, DQ and TCO
- 4. Operating the instrument fleet: calibration, performance verification, maintenance, failures, change control, requalification, periodic review and retirement
Part II — HPLC & UHPLC
- 5. HPLC/UHPLC architecture, platform selection and URS for modules and software
- 6. HPLC/UHPLC qualification and calibration (flow, gradient, injection, temperature, detector, carryover)
- 7. Columns, mobile phase, system suitability and HPLC→UHPLC transfer
- 8. HPLC/UHPLC troubleshooting and maintenance (pressure, peak shape, baseline, carryover, return to service)
Part III — GC & Headspace
- 9. GC systems: inlets, detectors, gases and point-of-use control
- 10. GC qualification and performance checks
- 11. Headspace GC: equilibration, sampling and reproducibility
- 12. GC/HS troubleshooting and maintenance (leaks, peaks, retention)
Part IV — Spectroscopy, LC-MS & ICP-MS
- 13. UV-Vis: qualification and problems (wavelength, photometry, stray light, cuvettes, baseline)
- 14. FTIR and Raman: qualification, performance verification and identity
- 15. LC-MS in QC: requirements, qualification, contamination and matrix effects
- 16. ICP-MS (and ICP-OES) in QC: qualification, blanks and interferences
Part V — Dissolution and Physical Testing
- 17. Dissolution apparatus: mechanical qualification and performance verification
- 18. Dissolution testing: medium, deaeration, temperature, sampling and automation
- 19. Disintegration, friability and breaking force
- 20. Abnormal results with a possible instrument cause: phase I investigation, OOS and return to service
Part VI — TOC and Physicochemical Measurements
- 21. Laboratory TOC: technologies, calibration, system suitability and problems
- 22. Volumetric and coulometric Karl Fischer titration
- 23. pH measurement
- 24. Conductivity measurement
Appendices A–F. 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.
What the package contains
After payment you download a ZIP file with the guide and the toolkit in the language of the chosen variant.
- The complete PDF guide. 309 A4 pages in the Italian edition, 308 in the English one; clickable table of contents and bookmarks.
- 24 editable tools. 12 Word templates and 12 Excel workbooks, in the folders 01_Qualification_Lifecycle…06_TOC_Physicochemical.
- 24 filled-in examples and demonstration datasets. 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.
- Support files. README, toolkit index, field glossary and chapter–toolkit–article matrix in the 00_Read_Me folder.
- Verification. 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.
Read the excerpt before you buy
The 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.
Specifications
| Format | A4 PDF with clickable table of contents and bookmarks; tools in .docx and .xlsx |
| Pages and chapters | 309 pages (ITA edition) · 308 pages (ENG edition) · 24 chapters in six parts + 6 appendices (A–F) |
| Toolkit | 24 editable tools: 12 Word + 12 Excel, codes AN-TK-01…24, plus 24 filled-in examples |
| File languages | One language per purchase: ITA - Italiano or ENG - English. There are no files in French, German or Spanish. |
| Edition and revision | First edition, October 2026 · v1.0 · tools rev. 1.0 |
| Regulatory verification | 02/10/2026 (status of every source as of that date) |
| References | EU (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 |
| Sources and decisions | 121 sources in the Appendix B register · 106 decisions tracked in Appendix D |
| Free excerpt | 15 pages (ITA edition) · 15 pages (ENG edition) |
| Updates | When the texts change, you receive the revised guide and toolkit at no extra cost. |
| Delivery | Digital 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. |
| Software requirements | A 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. |
| Licence | Individual 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. |
| Price | €199.00 per variant (guide + toolkit in the chosen language) |
Limits of use
- The Excel workbooks are calculation templates with specification, tests and limits, not validated software: before GMP use, the laboratory verifies them in its own quality system by repeating the relevant Test Log cases.
- Simulated 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.
- No 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.
- The guide does not replace the official texts cited and is not personalised legal, regulatory or quality advice.
- The 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.
- The numerical examples were recalculated independently by the editorial team; the guide and the toolkit have not undergone independent third-party validation.
Who it is for. 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 select, qualify, verify, repair or govern QC laboratory instruments: 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.
Who it is not for. 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.
Frequently asked questions
Which language are the files in?
The language of the chosen variant: ITA - Italiano or ENG - English. Each purchase includes the guide and the toolkit in one language. There are no files in French, German or Spanish.
Is it a printed book?
No. 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.
Does the guide give tolerances, %RSD or calibration frequencies that apply to everyone?
No, 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&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).
Do the tools say whether an instrument is qualified or a result is valid?
No. 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.
Does it reproduce USP and Ph. Eur. criteria and tables?
No. 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.
Does it take the revision of USP 〈1058〉 into account?
Yes, 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).
Does it apply to the United States?
The 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&A on laboratory controls and informational USP chapters such as 〈1058〉, which set no requirements, without reproducing their text.
Are the Excel workbooks validated?
They 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.
What happens when the reference texts change?
Appendix 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.
Can I share the files with colleagues, suppliers or service engineers?
The 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.
Before you buy: the Analytical Instrumentation hub
The 37 technical articles of the Analytical Instrumentation hub introduce the six areas of the guide, from instrument qualification under USP 〈1058〉 to conductivity measurement.
Go to the Analytical Instrumentation hub →Do you have an instrument to qualify, an open investigation or an instrument fleet to bring back under control?
Describe 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.
Describe your situation →No purchase obligation. The request is reviewed before any referral to a specialist.
GuideGxP 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.
