https://www.guidegxp.com/it daily https://www.guidegxp.com/it/products/guida-qualified-person-qp 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/10-qualified-person-qp.png?v=1784927283 Guida Operativa Qualified Person (QP) – Annex 16 / Rilascio Lotti https://www.guidegxp.com/it/products/guida-qa-manager 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/CopertinaQAmanagerv3.png?v=1785764654 Guida operativa al ruolo del QA Manager in ambito farmaceutico https://www.guidegxp.com/it/products/guida-regulatory-affairs 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/19-regulatory-affairs.png?v=1784928815 Guida completa ai Regulatory Affairs nell'Industria Farmaceutica https://www.guidegxp.com/it/products/guida-pharmacovigilance 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/44-pharmacovigilance-qppv.png?v=1784929569 Guida alla Figura del Responsabile di Farmacovigilanza (QPPV) e del Suo Team https://www.guidegxp.com/it/products/guida-gdp-responsible-person 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/43-gdp-responsible-person.png?v=1784929532 Il GDP Responsible Person: Guida Completa alla Buona Distribuzione Farmaceutica https://www.guidegxp.com/it/products/guida-manufacturing-manager-farmaceutica 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/42-pharmaceutical-manufacturing-manager.png?v=1784929503 Guida Tecnica del Manufacturing Manager in Azienda Farmaceutica https://www.guidegxp.com/it/products/guida-validation-calibration-farmaceutico 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/09-validation-calibration-manager_82d6b5ac-9623-4981-b03d-c61a59a42edf.png?v=1784927231 Guida al Validation Manager e Calibration Manager in Azienda Farmaceutica https://www.guidegxp.com/it/products/guida-iso-14644 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/41-iso-14644-series.png?v=1784929447 Guida Operativa alla Serie ISO 14644 per le Industrie Farmaceutiche https://www.guidegxp.com/it/products/guida-annex-gmp-1-15-16-20 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/03-gmp-annexes-1-15-16-20.png?v=1784926913 Guida Operativa agli Annex GMP 1, 15, 16 e 20 – Con Best Practices https://www.guidegxp.com/it/products/sop-self-inspection-gmp 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/08-pharmaceutical-self-inspections.png?v=1784927142 SOP: Autoispezioni in ambito Pharma https://www.guidegxp.com/it/products/sop-validazione-metodi-analitici 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/ANALYTICALMETHODVALIDATION_COVER.png?v=1775986767 SOP Analytical Method Validation GMP https://www.guidegxp.com/it/products/quality-guidelines-ich-q-la-guida-completa-a-q8-q9-q10-q12 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/18-ich-quality-guidelines.png?v=1784928782 Quality Guidelines ICH Q – La Guida Completa a Q8, Q9, Q10, Q12 https://www.guidegxp.com/it/products/safety-guidelines-ich-s-tossicologia-genotossicita-carcinogenicita-risk-assessment 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/17-ich-safety-guidelines.png?v=1784928754 Safety Guidelines ICH S – Tossicologia, Genotossicità, Carcinogenicità & Risk Assessment https://www.guidegxp.com/it/products/efficacy-guidelines-ich-e-studi-clinici-gcp-e6r3-struttura-globale 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/16-ich-efficacy-guidelines.png?v=1784928720 Efficacy Guidelines ICH E – Studi Clinici, GCP, E6(R3) & Struttura Globale https://www.guidegxp.com/it/products/multidisciplinary-guidelines-ich-m-ctd-ectd-stabilita-bioequivalenza-sottomissioni-globali 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/40-ich-multidisciplinary-guidelines.png?v=1784930593 Multidisciplinary Guidelines ICH M – CTD/eCTD, Stabilità, Bioequivalenza & Sottomissioni Globali https://www.guidegxp.com/it/products/alcoa-data-governance-la-guida-operativa-definitiva-per-la-data-integrity-pharma 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/06-alcoa-data-governance.png?v=1784927061 ALCOA+ & Data Governance – La Guida Operativa Definitiva per la Data Integrity Pharma https://www.guidegxp.com/it/products/audit-trail-review-step-by-step-la-guida-operativa-definitiva-per-qc-e-produzione 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/15-audit-trail-review.png?v=1784928667 Audit Trail Review Step-by-Step – La Guida Operativa Definitiva per QC e Produzione https://www.guidegxp.com/it/products/data-integrity-in-qc-labs-hplc-gc-empower-lims-eln-guida-operativa-audit-ready 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/14-data-integrity-qc-labs.png?v=1784928615 Data Integrity in QC Labs – HPLC, GC, Empower, LIMS, ELN Guida Operativa Audit-Ready https://www.guidegxp.com/it/products/pic-s-struttura-funzionamento-documenti-e-aide-memoires-1 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/39-pics-structure-documents.png?v=1784930529 Introduzione a PIC/S: Struttura, Funzionamento, Documenti e Aide-Memoires https://www.guidegxp.com/it/products/come-prepararsi-a-un-ispezione-pic-s-guida-operativa-audit-ready 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/38-pics-inspection-readiness.png?v=1784930502 Come Prepararsi a un’Ispezione PIC/S – Guida Operativa Audit-Ready https://www.guidegxp.com/it/products/documenti-pic-s-pi-aide-memoires-e-linee-guida-operative-come-leggerli-interpretarli-e-applicarli 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/37-pics-documents-aide-memoires.png?v=1784930429 Documenti PIC/S PI, Aide- Memoires e Linee Guida Operative: Come Leggerli, Interpretarli e Applicarli https://www.guidegxp.com/it/products/usp-382-guida-all-implementazione-per-sistemi-di-chiusura-parenterali 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/13-usp-382-parenteral-packaging.png?v=1784928577 USP 382 guida all’implementazione per sistemi di chiusura parenterali https://www.guidegxp.com/it/products/guida-operativa-alla-cleaning-validation-in-ambito-gmp 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/05-cleaning-validation.png?v=1784926992 Guida operativa alla cleaning validation in Ambito GMP https://www.guidegxp.com/it/products/guida-operativa-all-implementazione-dell-annex-1-eu-gmp-rev-2022 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/call_dAtRykZjqtSG2eoo6k9CQvos.png?v=1784929864 Guida Operativa all’Implementazione dell’Annex 1 EU GMP (Rev. 2022) https://www.guidegxp.com/it/products/contamination-control-strategy-ccs-guida-operativa-annex-1-eu-gmp 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/12-contamination-control-strategy.png?v=1784928528 Contamination Control Strategy (CCS) – Guida Operativa Annex 1 EU GMP https://www.guidegxp.com/it/products/aseptic-process-simulation-media-fill-guida-pratica-secondo-annex-1-eu-gmp 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/35-aseptic-process-simulation-media-fill.png?v=1784929389 Aseptic Process Simulation (Media Fill) – Guida Pratica secondo Annex 1 EU GMP https://www.guidegxp.com/it/products/guida-operativa-alla-computer-system-validation-csv-in-ambito-gxp 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/guidetocsv_august2026.png?v=1786951358 Guida Operativa alla Computer System Validation (CSV) in Ambito GxP https://www.guidegxp.com/it/products/computer-software-assurance-csa-guida-operativa-gxp 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/34-computer-software-assurance.png?v=1784929359 Computer Software Assurance (CSA) – Guida Operativa GxP https://www.guidegxp.com/it/products/saas-cloud-validation-guida-gxp-toolkit 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/11-saas-cloud-validation.png?v=1784928495 SaaS & Cloud Validation: Guida all’Implementazione GxP + template https://www.guidegxp.com/it/products/iso-14644-5-2025-guida-operativa-cleanroom 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/04-iso-14644-5-cleanroom.png?v=1784926955 ISO 14644-5:2025 – Guida Operativa alle Cleanroom Operations (Checklist & Audit Ready) https://www.guidegxp.com/it/products/farmacopee-a-confronto-gmp-gestione-divergenze 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/33-pharmacopeias-compared.png?v=1784929322 Farmacopee a Confronto GMP: Gestione operativa delle divergenze USP – Ph. Eur. – JP – BP in Audit GxP https://www.guidegxp.com/it/products/standard-di-riferimento-qc-nelle-farmacopee-gestione-gmp-tra-usp-e-ph-eur 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/32-qc-reference-standards.png?v=1784929262 Standard di Riferimento QC nelle Farmacopee: Gestione GMP tra USP e Ph. Eur. https://www.guidegxp.com/it/products/test-dissoluzione-metodi-compendiali-gmp 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/31-dissolution-testing.png?v=1784929188 Test di Dissoluzione e Metodi Compendiali nelle Farmacopee GMP – Guida Operativa Audit-Ready (USP, Ph. Eur.) https://www.guidegxp.com/it/products/farmacopee-gmp-impurita-saggi-critici-guida-operativa 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/30-pharmacopeial-impurities-critical-tests.png?v=1784929164 Farmacopee GMP – Impurità e Saggi Critici: gestione operativa multi-regione ICH vs USP vs Ph. Eur. https://www.guidegxp.com/it/products/farmacopee-audit-gmp-gestione-usp-ph-eur 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/29-pharmacopeias-gmp-audits.png?v=1784929122 Farmacopee e Audit GMP: Gestione operativa di USP, Ph. Eur. e compliance multi-regione in ispezione https://www.guidegxp.com/it/products/audit-interni-gmp-efficaci-difendibili-ispezione 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/28-internal-gmp-audits.png?v=1784929092 Audit Interni GMP: come renderli efficaci, risk-based e difendibili in ispezione AIFA/FDA/EMA https://www.guidegxp.com/it/products/extractables-leachables-gmp-guida-risk-based 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/27-extractables-leachables.png?v=1784929056 Extractables & Leachables (E&L) GMP – Guida Operativa Risk-Based per Decisioni Difendibili in Audit FDA/EMA https://www.guidegxp.com/it/products/validation-master-plan-gmp-guida-operativa-audit 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/26-validation-master-plan.png?v=1784929027 Validation Master Plan (VMP) GMP: Governare la Validazione e Difenderla in Audit EMA, AIFA, FDA e PIC/S https://www.guidegxp.com/it/products/deviazioni-capa-gmp-implementazione-efficace-audit 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/25-gmp-deviations-capa.png?v=1784928997 Deviazioni e CAPA GMP: Implementazione efficace e difendibilità in audit (EU GMP, FDA,AIFA, ICH Q10) https://www.guidegxp.com/it/products/bundle-qa-manager-toolkit-operativo-checklist-template-e-procedure 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/call_H4Qivaag3PNDxxacn1CT7Ml3.png?v=1784930175 Bundle QA Manager: Toolkit Operativo (Checklist, Template e Procedure). https://www.guidegxp.com/it/products/validation-master-plan-template-gmp-modello-editabile-pharma 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/VALIDATIONMASTERPLAN_COVER.png?v=1775904169 Validation Master Plan | Template GMP | Modello editabile Pharma https://www.guidegxp.com/it/products/sop-capa-gmp-corrective-and-preventive-action 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/CorrectiveandPreventiveAction_CAPA__COVER.png?v=1775915034 SOP CAPA GMP | Corrective and Preventive Action https://www.guidegxp.com/it/products/bundle-cleaning-validation-gmp-sop-e-protocollo 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/protocol_sopcleaningvalidation_COVER.png?v=1775916844 Bundle Cleaning Validation GMP | SOP + Protocol https://www.guidegxp.com/it/products/annex-1-sterility-assurance-toolkit 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/call_qdrNf7g8km3JObQ1vS59HLTu.png?v=1784929655 Annex 1 Sterility Assurance Toolkit https://www.guidegxp.com/it/products/guida-ai-gmp-annex-22-readiness 2026-08-17T17:04:27+02:00 daily https://cdn.shopify.com/s/files/1/0955/3320/3786/files/01_GuideGxP_AI_GMP_Cover.png?v=1786970481 Guida Operativa all'Artificial Intelligence in Ambito GMP — Annex 22 Readiness