First edition · August 2026
From design basis to periodic review: the complete lifecycle of a PW and WFI system
256 pages that follow a pharmaceutical water system from the business need to decommissioning: required quality, risk assessment, URS, pretreatment, choice of generation technology, distribution loop, materials and welding, automation and data integrity, vendor selection, commissioning, IQ/OQ/PQ, sampling, sanitisation, biofilm, change control. Plus 18 Excel and Word templates ready to be completed.
256 pages · A4 · PDF
19 chapters in 6 parts
18 Excel and Word templates
6 complete worked cases
Regulatory cut-off 23/08/2026
The guide
A manual of decisions, not a compilation of regulations: every chapter moves from the requirement to the decision, and from the decision to the objective evidence that holds it up in inspection.
The toolkit
18 editable tools in Italian and English — 36 files. Excel with formulas, dropdowns, dashboards and calculated outcomes; Word documents already 70% written, with section-by-section guidance.
Updates
Included for life. When PIC/S PI 006-4 and the new Ph. Eur. Issues become applicable, you receive the dedicated revision at no additional cost.
What this guide does and others do not
You will not find a loop velocity, a dead-leg L/D ratio, a slope or a PQ duration presented as a GMP requirement. No GMP text establishes them, and attributing them to ASME BPE or to an industry guide is the most expensive error in the sector's literature. What the guide gives you instead is the method: what each criterion actually depends on, who defines it, how it is justified and how it is demonstrated in inspection.
The 18 tools in the toolkit
Each one in Italian and English, built on the method of the chapter that explains it. No compendial limits and no pre-loaded frequencies: your site defines the criteria, the tools document them.
WORD01 · Project Brief
Scope, stakeholders, RACI, capacity, milestones and success criteria, before the project starts off in the wrong direction.
EXCEL02 · Water Quality & Intended Use Matrix
For every point of use, the minimum quality and the rationale behind it. The approval outcome is calculated.
WORD03 · System URS
112 pre-written requirements across 15 categories, with rationale, criticality, verification method and traceability.
EXCEL04 · Design Basis & Capacity Calculator
Average and peak demand, simultaneity, storage, redundancy. Three scenarios compared, with assumptions always visible.
EXCEL05 · QRM & Critical Control Point
Risk register with formula-driven score and class, identification of CCPs and a risk dashboard.
EXCEL06 · Generation Technology Comparison
RO, EDI, UF, distillation and hybrids across 14 weighted criteria, with knock-outs, sensitivity and regional constraints.
WORD07 · Design Review Checklist
Tank, loop, valves, dead legs, drainability: it fixes no values, it verifies that the criterion exists and is justified.
EXCEL08 · Equipment, P&ID & POU Register
Register of equipment, instruments and points, with automatic flagging of sampling points confused with points of use.
EXCEL09 · Vendor Bid Evaluation
Mandatory requirements with knock-out, weighted criteria, supplier assessment, TCO and automatic ranking.
WORD10 · FAT / SAT & Commissioning
60 pre-written tests, punch list and the checklist of conditions for reusing commissioning evidence in qualification.
WORD11 · IQ / OQ / PQ Protocol Set
89 checks across three coordinated protocols, including the section where you document the rationale for your own PQ.
EXCEL12 · Requirements Traceability Matrix
From the need to the evidence: coverage calculated requirement by requirement, with a dashboard of untraced items.
EXCEL13 · Sampling Plan & Point Rationale
Sampling plan with a mandatory rationale for each point and a control of sample points against points of use.
EXCEL14 · Monitoring, Alarm & Trending
Alarm rationalisation, excursion counting, recurrence indicator, excursion log and trend charts.
WORD15 · Sanitisation & Microbiological Control
Sanitisation strategy with cycle parameters, residual removal and the rationale behind the frequency.
EXCEL16 · Lifecycle & Periodic Review Planner
Maintenance, calibration, spare parts and obsolescence with calculated due dates and status, plus a signable periodic review.
WORD17 · Deviation, Biofilm & Rouging
Three investigation paths within a single documentation framework: excursion, suspected biofilm, rouging.
WORD18 · Change Impact & Retrofit
Impact assessment on the validated state, with a section dedicated to retrofits on systems already in operation.
You can use it tomorrow morning
| The situation | What you use |
|---|
| You have to decide whether to produce WFI by distillation or by membrane | Chapter 9 + Tool 06, with the regional constraints and the prior notification to the authority |
| A vendor sends you a quotation and you need to see what is missing | Chapter 7 (URS) + Tool 03, and the evaluation in Tool 09 |
| "Why does your PQ run for this long?" asks the inspector | Chapter 14 + Tool 11: a documented rationale, not a number copied from elsewhere |
| Microbiological excursions that return after every sanitisation | Chapter 16 + Tool 17: biofilm investigation and recovery strategy |
| You have to add points of use to an existing loop | Chapter 17 + Tool 18, and worked case 6 in Chapter 18 |
| Retrofit of a legacy loop without stopping production | Chapter 11 + worked case 4: tie-in, restoration, requalification scope |
| Inspection in two weeks | Chapter 19: inspection question tables, self-assessment, checklists and a 30/60/90 roadmap |
Regulatory rigour, declared line by line
Every statement carries one of eight labels: [REQUIREMENT] for a regulatory or compendial obligation, [GUIDANCE] for an expectation, [STANDARD] for a voluntary technical standard, [GEP] for good engineering practice, [QRM] for a decision that has to be justified, [GUIDEGXP] for the author's interpretation, [DRAFT] and [NOT YET APPLICABLE] for texts that are not in force.
The status of every source is verified as at 23 August 2026. The guide corrects the most widespread errors in the sector: Highly Purified Water no longer exists as a Ph. Eur. grade since 1 April 2019; ISO 22519:2019 has been withdrawn and the 2023 edition has a different scope; PDA TR 4 is retired; the FDA inspection guide on high purity water dates from 1993 and is not binding on the FDA.
No compendial limit is reproduced and no protected text is copied: the guide explains the method and refers to the official text for the values. It is vendor-neutral: no brands, no suppliers, no technology declared best in absolute terms.
What is inside
Part I — Foundations. Regulatory, pharmacopoeial and standards framework with the hierarchy of sources; water as a control system and the four levels that must not be confused.
Part II — Define. Governance and stage gates; intended use, required quality and design basis; Quality Risk Management and control strategy; the URS.
Part III — Design. Feed water and pretreatment; PW and WFI generation technologies; storage and distribution; hygienic design, materials, welding and installation; instrumentation, automation and the data lifecycle.
Part IV — Build. Architecture, vendor selection and procurement; DQ, FAT, SAT, commissioning, IQ/OQ/PQ and CSV.
Part V — Operate. Operational use and sampling; microbiological control, sanitisation and investigations; lifecycle management.
Part VI — Demonstrate. Six complete applied scenarios and inspection readiness with six decision trees.
Plus six appendices: source register, regulatory status matrix, chapter → source matrix, chapter → decision → document → toolkit → evidence matrix, a 91-entry glossary and the toolkit overview.
Read 20 pages before you buy
The free preview contains the Regulatory Status Box, the full table of contents with real page numbers, the hierarchy of sources and the regional differences on the methods accepted for WFI, the table of parameters that no GMP text fixes, one fully worked case and the inspection readiness checklist.
Specifications
| Format | PDF A4, 256 pages (ITA edition) · 256 pages (ENG edition) |
| Structure | 19 chapters in 6 parts + 6 appendices |
| Toolkit | 18 editable tools (10 Excel, 8 Word) in ITA and ENG — 36 files |
| Languages | Guide and toolkit are available in Italian and English. Select the variant before purchase |
| Regulatory cut-off | 23 August 2026, verified against official sources |
| Delivery | Immediate download after purchase |
| Licence | Individual use, internal to the purchasing company |
Who it is for. QA and Heads of Quality, Validation and CQV Managers, Engineering and Facility Managers, Utility and Process Engineers, Project Managers, QC Chemistry and QC Microbiology, Sterility Assurance, Automation and IT/CSV, Maintenance and Calibration, Procurement, Qualified Persons, consultants, EPCM contractors, system integrators and skid builders. It is written for practitioners: it does not explain what GMP is, it explains how decisions are made and how they are demonstrated.
Do you have a Pharmaceutical Water or WFI project?
Describe your requirement and request support from a selected specialist.
Request specialist support
GuideGxP guides do not replace official regulations (EMA, EU GMP, ICH, PIC/S, WHO, ISO, ASME, ASTM, FDA, pharmacopoeias): they are operational support tools, and the regulated user remains responsible for the correct application of the regulations in force in their own operating context. Design and control parameters have no universal value and must be defined and justified by the site. Digital product: no physical shipment.
