PRACTICAL GMP TOOLS FOR PHARMA
GMP Catalog
Practical GMP guides, SOPs, checklists and digital templates designed for QA, QC, Validation, Engineering, Production and Regulatory professionals. Tools that turn complex requirements into clearer actions, decisions and evidence.
- ✓Immediate digital access
- ✓Operational tools
- ✓Built for audits and inspections
THE GUIDEGXP METHOD
From requirement to practical action.
- 01 RequirementSources, standards and expectations ✓
- 02 DecisionClear, risk-based criteria ✓
- 03 ActionGuides, SOPs and templates ✓
- 04 EvidenceSolid, audit-ready outputs ✓
36resources available
100%digital access
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Operational Guide to the Role of the QA Manager in the Pharmaceutical Industry
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Operational Guide to Computer System Validation (CSV) in the GxP Environment
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ISO 14644-5:2025 – Operational Guide to Cleanroom Operations (Second Edition + Toolkit)
Regular price €129,00 EURRegular priceSale price €129,00 EUR -
Operational Guide to GMP Annexes 1, 15, 16 and 20 — Third Edition
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The Validation Master Plan (VMP) in GMP Facilities: Governing Validation, Proving It in Audit and Being Ready for PI 006-4
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Qualified Person (QP) — Operational Guide to Annex 16, Batch Certification and Release (Third Edition + Toolkit)
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Deviations, self-inspections and CAPA: the chain that holds up in inspection
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The Contamination Control Strategy in GMP Facilities – Annex 1 Operational Guide (Second Edition + Toolkit)
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Cleaning Validation in GMP Facilities – Operational Guide to HBEL, MACO and Defensible Limits (Second Edition + Toolkit)
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ICH M Multidisciplinary Guidelines: the CTD dossier, eCTD v4.0 and what actually applies
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A Guide to Validation Managers and Calibration Managers in Pharmaceutical Companies
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EU GMP Annex 1 (2022): The Complete Map — GuideGxP Operational Guide
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ICH E Efficacy Guidelines: E6(R3) and Annex 2 Readiness
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Elemental, Mutagenic and Nitrosamine Impurities: Risk Assessment under ICH Q3D and M7
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ICH Q Quality Guidelines: what is actually applicable, and readiness for the new Q1
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The GDP Responsible Person: A Complete Guide to Good Pharmaceutical Distribution
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