GxP Operational Guides for QA, QC, Validation and QP: checklists and templates to be audit-ready.
Our guides are based on the regulations and guidelines issued by leading bodies and organizations in the pharmaceutical sector.
Choose by Role
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EXPLOREQMS, Deviations/CAPA, Change Control, Audit Readiness.
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EXPLOREData Integrity, Audit Trail Review, Controls on Records and Systems.
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EXPLORECSV/CSA, Risk-Based Approach, SaaS/Cloud and Computerized Systems.
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EXPLOREDefensible Decisions, Oversight, Batch Release, and Inspection Readiness.
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EXPLOREAnnex 1, CCS, Cleanroom Operations, and Controls in Sterile Areas.
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EXPLORECold Chain, GDP Audits, Supplier Qualification, and Non-Conformity Management.
No Theory — Practical Tools Ready to Use
Inside each guide, you’ll find an operational structure designed for audits and inspections:
- “Audit-ready” checklists to verify evidence and controls
- Reusable templates and tables (where applicable)
- Typical mistakes that generate findings — and how to avoid them
- Risk-based approach for defensible decisions
- Implementation plan: what to do tomorrow — and in what order
Why Pharmaceutical Professionals Choose Us:
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BASED ON INTERNATIONAL STANDARDS
Content developed in alignment with EU GMP, EMA, ICH, PIC/S, ISO, and recognized regulatory guidelines. No vague interpretations — requirements translated into concrete, actionable steps.
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FROM REGULATION TO CHECKLIST
Each guide follows a clear structure: Requirement → Rationale → What to Do → How to Document It → Verification Checklist.
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RISK-BASED AND AUDIT-READY APPROACH
The guides are built on a risk-based logic aligned with ICH Q9 and Q10 principles, supporting technically sound and defensible decisions.
GxP Academy – Thematic Hubs for Pharma Compliance.Explore the key regulatory and operational topics within the GMP/GxP framework.Each area includes in-depth technical insights linked to operational guides.
EXPLORE ALL GUIDES-
EXPLOREALCOA+, Audit Trail Review, Electronic Records Governance, Computerized Systems.
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EXPLOREContamination Control Strategy (CCS), Media Fill, Cleanroom Operations.
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EXPLOREQ9, Q10, Q12 and the lifecycle approach applied to quality, risk, and the pharmaceutical quality system.
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EXPLORECritical compendial chapters, practical interpretation, and impact on business processes.
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EXPLOREInspection trends, recurring critical findings, and how to prepare in a structured way.
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EXPLOREDocumentation structure, deviations, CAPA, change control, and quality system.
The Most Purchased Guides
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ISO 14644-5:2025 – Operational Guide to Cleanroom Operations (Checklists & Audit Ready)
Regular price €129,00 EURRegular price -
Operational Guide to GMP Cleaning Validation
Regular price €149,00 EURRegular price -
USP 382 – Implementation Guide for Parenteral Closure Systems
Regular price €199,00 EURRegular price -
Operational Guide to GMP Annexes 1, 15, 16 and 20 – With Best Practices
Regular price €89,00 EURRegular price
