{"product_id":"guida-acqua-farmaceutica-wfi-gmp","title":"Guida Operativa ai Sistemi di Acqua Farmaceutica e WFI in ambito GMP","description":"\u003cdiv style=\"font-family:-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif;color:#1f2430;line-height:1.6\"\u003e\n\n\u003cdiv style=\"background:#12395c;background-image:radial-gradient(circle at 78% 12%,#1f4e79 0%,#16405f 38%,#08192b 100%);border-radius:14px;padding:34px 30px 30px 30px;color:#ffffff;margin-bottom:26px\"\u003e\n  \u003cdiv style=\"display:inline-block;background:#4fd1c5;color:#062a33;font-size:12px;font-weight:700;letter-spacing:1.6px;text-transform:uppercase;padding:6px 12px;border-radius:4px;margin-bottom:16px\"\u003ePrima edizione · Agosto 2026\u003c\/div\u003e\n  \u003ch3 style=\"margin:0 0 12px 0;font-size:29px;line-height:1.25;color:#ffffff;font-weight:800\"\u003eDal design basis alla periodic review: il ciclo di vita completo di un sistema PW e WFI\u003c\/h3\u003e\n  \u003cp style=\"margin:0 0 20px 0;font-size:16px;color:#d6e6ef;max-width:660px\"\u003e256 pagine che seguono un impianto di acqua farmaceutica dall'esigenza aziendale al decommissioning: qualità richiesta, risk assessment, URS, pretrattamento, scelta della tecnologia di generazione, loop di distribuzione, materiali e saldature, automazione e data integrity, fornitore, commissioning, IQ\/OQ\/PQ, campionamento, sanitizzazione, biofilm, change control. Più 18 template Excel e Word pronti da compilare.\u003c\/p\u003e\n  \u003cdiv style=\"display:flex;flex-wrap:wrap;gap:9px\"\u003e\n    \u003cspan style=\"background:#1f4e79;color:#d6e6ef;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e256 pagine · A4 · PDF\u003c\/span\u003e\n    \u003cspan style=\"background:#1f4e79;color:#d6e6ef;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e19 capitoli in 6 parti\u003c\/span\u003e\n    \u003cspan style=\"background:#1f4e79;color:#d6e6ef;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e18 template Excel e Word\u003c\/span\u003e\n    \u003cspan style=\"background:#1f4e79;color:#d6e6ef;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e6 casi applicativi completi\u003c\/span\u003e\n    \u003cspan style=\"background:#1f4e79;color:#d6e6ef;font-size:13px;padding:7px 13px;border-radius:20px\"\u003eCut-off normativo 23\/08\/2026\u003c\/span\u003e\n  \u003c\/div\u003e\n\u003c\/div\u003e\n\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:14px;margin-bottom:30px\"\u003e\n  \u003cdiv style=\"flex:1 1 210px;background:#f5f9fb;border:1px solid #dde8ee;border-radius:11px;padding:19px\"\u003e\n    \u003cdiv style=\"font-size:12px;font-weight:700;color:#0e6b7a;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eLa guida\u003c\/div\u003e\n    \u003cdiv style=\"font-size:15px;color:#333a48\"\u003eUn manuale di decisioni, non una raccolta normativa: ogni capitolo porta dal requisito alla decisione, e dalla decisione all'evidenza che la regge in ispezione.\u003c\/div\u003e\n  \u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 210px;background:#f5f9fb;border:1px solid #dde8ee;border-radius:11px;padding:19px\"\u003e\n    \u003cdiv style=\"font-size:12px;font-weight:700;color:#0e6b7a;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eIl toolkit\u003c\/div\u003e\n    \u003cdiv style=\"font-size:15px;color:#333a48\"\u003e18 strumenti editabili in italiano e in inglese — 36 file. Excel con formule, dropdown, dashboard ed esiti calcolati; Word già scritti al 70%, con guidance sezione per sezione.\u003c\/div\u003e\n  \u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 210px;background:#f5f9fb;border:1px solid #dde8ee;border-radius:11px;padding:19px\"\u003e\n    \u003cdiv style=\"font-size:12px;font-weight:700;color:#0e6b7a;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eAggiornamenti\u003c\/div\u003e\n    \u003cdiv style=\"font-size:15px;color:#333a48\"\u003eInclusi a vita. Quando PIC\/S PI 006-4 e le nuove Issue della Ph. Eur. diventeranno applicabili, ricevi la revisione dedicata senza costi aggiuntivi.\u003c\/div\u003e\n  \u003c\/div\u003e\n\u003c\/div\u003e\n\n\u003cdiv style=\"background:#0e2e49;border-radius:12px;padding:22px 24px;margin-bottom:30px;color:#e6f1f7\"\u003e\n  \u003cdiv style=\"font-size:12px;font-weight:700;color:#4fd1c5;letter-spacing:1.4px;text-transform:uppercase;margin-bottom:10px\"\u003eQuello che questa guida fa e le altre no\u003c\/div\u003e\n  \u003cdiv style=\"font-size:15px;line-height:1.65\"\u003eNon troverai una velocità nel loop, un rapporto L\/D per i dead leg, una pendenza o una durata della PQ presentati come requisiti GMP. \u003cstrong style=\"color:#ffffff\"\u003eNessuna GMP li stabilisce\u003c\/strong\u003e, e attribuirli ad ASME BPE o a una guida industriale è l'errore più costoso della letteratura di settore. La guida ti dà invece il metodo: da che cosa dipende ciascun criterio, chi lo definisce, come si giustifica e come si dimostra in ispezione.\u003c\/div\u003e\n\u003c\/div\u003e\n\n\u003ch3 style=\"font-size:22px;margin:0 0 6px 0;color:#12395c\"\u003eI 18 strumenti del toolkit\u003c\/h3\u003e\n\u003cp style=\"margin:0 0 18px 0;font-size:15px;color:#5a6273\"\u003eOgnuno in italiano e in inglese, nato dal metodo del capitolo che lo spiega. Nessun limite compendiale e nessuna frequenza precaricata: i criteri li definisce il tuo sito, gli strumenti li documentano.\u003c\/p\u003e\n\n\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:10px;margin-bottom:28px\"\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#185abd;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e01 · Project Brief\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003ePerimetro, stakeholder, RACI, capacità, milestone e criteri di successo prima che il progetto parta storto.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#1d6f42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e02 · Water Quality \u0026amp; Intended Use Matrix\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003ePer ogni punto d'uso, la qualità minima e il razionale. L'esito di approvazione è calcolato.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#185abd;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e03 · URS del sistema\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003e112 requisiti già scritti su 15 categorie, con rationale, criticità, metodo di verifica e tracciabilità.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#1d6f42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e04 · Design Basis \u0026amp; Capacity Calculator\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eDomanda media e di picco, simultaneità, stoccaggio, ridondanza. Tre scenari a confronto, assunzioni sempre visibili.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#1d6f42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e05 · QRM \u0026amp; Critical Control Point\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eRisk register con punteggio e classe a formula, identificazione dei CCP e dashboard di rischio.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#1d6f42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e06 · Generation Technology Comparison\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eRO, EDI, UF, distillazione e ibridi su 14 criteri pesati, con knock-out, sensitivity e vincoli regionali.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#185abd;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e07 · Design Review Checklist\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eSerbatoio, loop, valvole, dead leg, drenabilità: non fissa valori, verifica che il criterio esista e sia giustificato.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#1d6f42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e08 · Equipment, P\u0026amp;ID \u0026amp; POU Register\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eRegistro di apparecchiature, strumenti e punti, con segnalazione automatica dei punti di campionamento confusi con i punti d'uso.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#1d6f42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e09 · Vendor Bid Evaluation\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eRequisiti mandatori con knock-out, criteri pesati, supplier assessment, TCO e ranking automatico.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#185abd;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e10 · FAT \/ SAT \u0026amp; Commissioning\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003e60 prove pre-scritte, punch list e la checklist delle condizioni per riutilizzare l'evidenza in qualifica.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#185abd;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e11 · IQ \/ OQ \/ PQ Protocol Set\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003e89 verifiche su tre protocolli coordinati, con la sezione in cui documenti il razionale della tua PQ.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#1d6f42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e12 · Requirements Traceability Matrix\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eDal need all'evidenza: copertura calcolata requisito per requisito e dashboard dei non tracciati.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#1d6f42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e13 · Sampling Plan \u0026amp; Point Rationale\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003ePiano di campionamento con razionale obbligatorio per punto e controllo sample point contro point of use.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#1d6f42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e14 · Monitoring, Alarm \u0026amp; Trending\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eRazionalizzazione degli allarmi, conteggio dei superamenti, indicatore di ricorrenza, excursion log e grafici.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#185abd;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e15 · Sanitisation \u0026amp; Microbiological Control\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eStrategia di sanitizzazione con parametri di ciclo, rimozione del residuo e razionale della frequenza.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#1d6f42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e16 · Lifecycle \u0026amp; Periodic Review Planner\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eManutenzione, taratura, ricambi e obsolescenza con scadenze e stato calcolati, più la periodic review firmabile.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#185abd;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e17 · Deviation, Biofilm \u0026amp; Rouging\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eTre percorsi di indagine in un unico impianto documentale: excursion, sospetto biofilm, rouging.\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003cdiv style=\"flex:1 1 235px;background:#ffffff;border:1px solid #dde8ee;border-radius:10px;padding:14px\"\u003e\n\u003cspan style=\"display:inline-block;background:#185abd;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:7px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:14.5px;color:#12395c;margin-bottom:4px\"\u003e18 · Change Impact \u0026amp; Retrofit\u003c\/div\u003e\n\u003cdiv style=\"font-size:13.5px;color:#5a6273\"\u003eValutazione d'impatto sullo stato validato, con la sezione dedicata al retrofit su impianto in esercizio.\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\n\u003ch3 style=\"font-size:22px;margin:0 0 14px 0;color:#12395c\"\u003eLo usi da domani mattina\u003c\/h3\u003e\n\u003ctable style=\"width:100%;border-collapse:collapse;font-size:14.5px;margin-bottom:28px\"\u003e\n  \u003ctr style=\"background:#12395c;color:#fff\"\u003e\n\u003cth style=\"text-align:left;padding:11px 13px\"\u003eLa situazione\u003c\/th\u003e\n\u003cth style=\"text-align:left;padding:11px 13px\"\u003eChe cosa usi\u003c\/th\u003e\n\u003c\/tr\u003e\n  \u003ctr style=\"background:#f5f9fb\"\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eDevi decidere se il WFI lo fai per distillazione o a membrana\u003c\/td\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eCapitolo 9 + Strumento 06, con i vincoli regionali e la notifica preventiva all'autorità\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eIl fornitore ti manda un'offerta e vuoi capire cosa manca\u003c\/td\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eCapitolo 7 (URS) + Strumento 03, e la valutazione dello Strumento 09\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr style=\"background:#f5f9fb\"\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003e\"Perché la PQ dura così?\" chiede l'ispettore\u003c\/td\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eCapitolo 14 + Strumento 11: il razionale documentato, non un numero copiato\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eSuperamenti microbiologici che tornano dopo ogni sanitizzazione\u003c\/td\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eCapitolo 16 + Strumento 17: indagine sul biofilm e strategia di recupero\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr style=\"background:#f5f9fb\"\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eDevi aggiungere punti d'uso a un loop esistente\u003c\/td\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eCapitolo 17 + Strumento 18, e il caso applicativo 6 del Capitolo 18\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eRetrofit di un loop legacy senza fermare la produzione\u003c\/td\u003e\n\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #dde8ee\"\u003eCapitolo 11 + caso applicativo 4: tie-in, ripristino, perimetro di riqualifica\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr style=\"background:#f5f9fb\"\u003e\n\u003ctd style=\"padding:11px 13px\"\u003eIspezione fra due settimane\u003c\/td\u003e\n\u003ctd style=\"padding:11px 13px\"\u003eCapitolo 19: tavole di domande ispettive, self-assessment, checklist e roadmap 30\/60\/90\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e\n\n\u003cdiv style=\"background:#fdf6e3;border-left:4px solid #c9a227;border-radius:0 9px 9px 0;padding:19px 21px;margin-bottom:28px\"\u003e\n  \u003cdiv style=\"font-weight:700;color:#7a5c00;font-size:15px;margin-bottom:8px\"\u003eRigore normativo, dichiarato riga per riga\u003c\/div\u003e\n  \u003cdiv style=\"font-size:14.5px;color:#4a4530\"\u003eOgni affermazione porta un'etichetta fra otto: \u003cstrong\u003e[REQUISITO]\u003c\/strong\u003e per un obbligo normativo o compendiale, \u003cstrong\u003e[GUIDANCE]\u003c\/strong\u003e per un'aspettativa, \u003cstrong\u003e[STANDARD]\u003c\/strong\u003e per uno standard tecnico volontario, \u003cstrong\u003e[GEP]\u003c\/strong\u003e per la buona pratica ingegneristica, \u003cstrong\u003e[QRM]\u003c\/strong\u003e per una decisione da giustificare, \u003cstrong\u003e[GUIDEGXP]\u003c\/strong\u003e per un'interpretazione dell'autore, \u003cstrong\u003e[DRAFT]\u003c\/strong\u003e e \u003cstrong\u003e[NON ANCORA APPLICABILE]\u003c\/strong\u003e per i testi che non sono in vigore.\u003cbr\u003e\u003cbr\u003e\n  Lo stato di ogni fonte è verificato al \u003cstrong\u003e23 agosto 2026\u003c\/strong\u003e. La guida corregge gli errori più diffusi del settore: \u003cstrong\u003eHighly Purified Water non esiste più\u003c\/strong\u003e come grado Ph. Eur. dal 1° aprile 2019; \u003cstrong\u003eISO 22519:2019 è ritirata\u003c\/strong\u003e e l'edizione 2023 ha scope diverso; \u003cstrong\u003ePDA TR 4 è retired\u003c\/strong\u003e; la guida ispettiva FDA sull'acqua ad alta purezza è del 1993 e non vincola la FDA.\u003cbr\u003e\u003cbr\u003e\n  Nessun limite compendiale è riprodotto e nessun testo protetto è copiato: la guida spiega \u003cem\u003eil metodo\u003c\/em\u003e e rimanda al testo ufficiale per i valori. È vendor-neutral: nessun marchio, nessun fornitore, nessuna tecnologia dichiarata migliore in assoluto.\u003c\/div\u003e\n\u003c\/div\u003e\n\n\u003ch3 style=\"font-size:22px;margin:0 0 12px 0;color:#12395c\"\u003eChe cosa c'è dentro\u003c\/h3\u003e\n\u003cdiv style=\"font-size:15px;color:#333a48;margin-bottom:28px\"\u003e\n  \u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12395c\"\u003eParte I — Fondamenti.\u003c\/strong\u003e Quadro regolatorio, farmacopoeiale e standard con la gerarchia delle fonti; l'acqua come sistema di controllo e i quattro piani da non confondere.\u003c\/p\u003e\n  \u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12395c\"\u003eParte II — Definire.\u003c\/strong\u003e Governance e stage-gate; intended use, qualità richiesta e design basis; Quality Risk Management e control strategy; l'URS.\u003c\/p\u003e\n  \u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12395c\"\u003eParte III — Progettare.\u003c\/strong\u003e Acqua di alimentazione e pretrattamento; tecnologie di generazione PW e WFI; stoccaggio e distribuzione; hygienic design, materiali, saldature e installazione; strumentazione, automazione e data lifecycle.\u003c\/p\u003e\n  \u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12395c\"\u003eParte IV — Realizzare.\u003c\/strong\u003e Architettura, fornitore e procurement; DQ, FAT, SAT, commissioning, IQ\/OQ\/PQ e CSV.\u003c\/p\u003e\n  \u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12395c\"\u003eParte V — Gestire.\u003c\/strong\u003e Utilizzo operativo e campionamento; controllo microbiologico, sanitizzazione e investigazioni; lifecycle management.\u003c\/p\u003e\n  \u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#12395c\"\u003eParte VI — Dimostrare.\u003c\/strong\u003e Sei scenari applicativi completi e inspection readiness con sei decision tree.\u003c\/p\u003e\n  \u003cp style=\"margin:0\"\u003ePiù sei appendici: registro delle fonti, regulatory status matrix, matrice capitolo → fonte, matrice capitolo → decisione → documento → toolkit → evidenza, glossario di 91 voci e panoramica del toolkit.\u003c\/p\u003e\n\u003c\/div\u003e\n\n\u003cdiv style=\"background:#f5f9fb;border:1px solid #dde8ee;border-radius:12px;padding:22px 24px;margin-bottom:28px\"\u003e\n  \u003ch3 style=\"font-size:22px;margin:0 0 8px 0;color:#12395c\"\u003eLeggi 20 pagine prima di comprare\u003c\/h3\u003e\n  \u003cp style=\"margin:0 0 16px 0;font-size:15px;color:#5a6273;max-width:660px\"\u003eL’estratto gratuito contiene il Regulatory Status Box, l’indice completo dell’edizione con i numeri di pagina reali, la gerarchia delle fonti e le differenze regionali sui metodi ammessi per il WFI, la tabella dei parametri che nessuna GMP fissa, un caso applicativo integrale e la checklist di inspection readiness.\u003c\/p\u003e\n  \u003cdiv style=\"display:flex;flex-wrap:wrap;gap:10px\"\u003e\n    \u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Pharmaceutical_Water_WFI_GMP_Preview_1ed_ITA.pdf?v=1787510733\" style=\"display:inline-block;background:#12395c;color:#ffffff;font-weight:700;font-size:15px;text-decoration:none;padding:12px 22px;border-radius:6px\"\u003eEstratto gratuito — Italiano (PDF)\u003c\/a\u003e\n    \u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Pharmaceutical_Water_WFI_GMP_Preview_1ed_ENG.pdf?v=1787510734\" style=\"display:inline-block;background:#ffffff;color:#12395c;border:1.5px solid #12395c;font-weight:700;font-size:15px;text-decoration:none;padding:11px 21px;border-radius:6px\"\u003eFree preview — English (PDF)\u003c\/a\u003e\n  \u003c\/div\u003e\n\u003c\/div\u003e\n\n\u003ch3 style=\"font-size:22px;margin:0 0 14px 0;color:#12395c\"\u003eSpecifiche\u003c\/h3\u003e\n\u003ctable style=\"width:100%;border-collapse:collapse;font-size:14.5px;margin-bottom:24px\"\u003e\n  \u003ctr style=\"background:#f5f9fb\"\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee;width:34%;font-weight:600;color:#12395c\"\u003eFormato\u003c\/td\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee\"\u003ePDF A4, 256 pagine (edizione ITA) · 256 pagine (edizione ENG)\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee;font-weight:600;color:#12395c\"\u003eStruttura\u003c\/td\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee\"\u003e19 capitoli in 6 parti + 6 appendici\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr style=\"background:#f5f9fb\"\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee;font-weight:600;color:#12395c\"\u003eToolkit\u003c\/td\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee\"\u003e18 strumenti editabili (10 Excel, 8 Word) in ITA ed ENG — 36 file\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee;font-weight:600;color:#12395c\"\u003eLingue\u003c\/td\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee\"\u003eGuida e toolkit sono disponibili in italiano e in inglese. Seleziona la variante prima di acquistare\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr style=\"background:#f5f9fb\"\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee;font-weight:600;color:#12395c\"\u003eCut-off normativo\u003c\/td\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee\"\u003e23 agosto 2026, verificato su fonti ufficiali\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee;font-weight:600;color:#12395c\"\u003eConsegna\u003c\/td\u003e\n\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #dde8ee\"\u003eDownload immediato dopo l'acquisto\u003c\/td\u003e\n\u003c\/tr\u003e\n  \u003ctr style=\"background:#f5f9fb\"\u003e\n\u003ctd style=\"padding:10px 13px;font-weight:600;color:#12395c\"\u003eLicenza\u003c\/td\u003e\n\u003ctd style=\"padding:10px 13px\"\u003eUso individuale e interno all'azienda acquirente\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e\n\n\u003cdiv style=\"background:#f5f9fb;border:1px solid #dde8ee;border-radius:11px;padding:18px 21px;margin-bottom:24px;font-size:14.5px;color:#333a48\"\u003e\n  \u003cstrong style=\"color:#12395c\"\u003ePer chi è.\u003c\/strong\u003e QA e Head of Quality, Validation e CQV Manager, Engineering e Facility Manager, Utility e Process Engineer, Project Manager, QC Chimica e QC Microbiologia, Sterility Assurance, Automation e IT\/CSV, Maintenance e Calibration, Procurement, Qualified Person, consulenti, EPCM, system integrator e costruttori di skid. È scritta per professionisti: non spiega che cos'è la GMP, spiega come si decide e come si dimostra.\n\u003c\/div\u003e\n\n\u003cdiv style=\"background:#12395c;background-image:linear-gradient(135deg,#16405f 0%,#08192b 100%);border-radius:12px;padding:24px 26px;color:#fff;margin-bottom:20px\"\u003e\n  \u003cdiv style=\"font-size:18px;font-weight:700;margin-bottom:8px;color:#ffffff\"\u003eHai un progetto Pharmaceutical Water o WFI?\u003c\/div\u003e\n  \u003cdiv style=\"font-size:15px;color:#d6e6ef;margin-bottom:16px;max-width:640px\"\u003eDescrivi l'esigenza e richiedi il supporto di uno specialista selezionato.\u003c\/div\u003e\n  \u003ca href=\"https:\/\/www.guidegxp.com\/it\/pages\/expert-support?area=pharmaceutical-water-wfi\u0026amp;source=product-pharmaceutical-water-wfi-guide\u0026amp;cta=product-page\" style=\"display:inline-block;background:#4fd1c5;color:#062a33;font-weight:700;font-size:15px;text-decoration:none;padding:11px 22px;border-radius:6px\"\u003eRichiedi supporto specialistico\u003c\/a\u003e\n\u003c\/div\u003e\n\n\u003cp style=\"font-size:12.5px;color:#8a90a0;margin:0\"\u003eLe guide GuideGxP non sostituiscono la normativa ufficiale (EMA, EU GMP, ICH, PIC\/S, WHO, ISO, ASME, ASTM, FDA, farmacopee): sono strumenti di supporto operativo e l'utente resta responsabile della corretta applicazione delle normative vigenti nel proprio contesto aziendale. I parametri di progetto e di controllo non hanno un valore universale e vanno definiti e giustificati dal sito. Prodotto digitale: nessuna spedizione fisica.\u003c\/p\u003e\n\n\u003c\/div\u003e\n","brand":"GuideGxP","offers":[{"title":"ITA - Italiano","offer_id":63240040251722,"sku":null,"price":199.0,"currency_code":"EUR","in_stock":true},{"title":"ENG - English","offer_id":63240040284490,"sku":null,"price":199.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/cover-eng.png?v=1787510446","url":"https:\/\/www.guidegxp.com\/it\/products\/guida-acqua-farmaceutica-wfi-gmp","provider":"GuideGxP","version":"1.0","type":"link"}