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GXP ACADEMY · GXP INSIGHTS
Practical analysis of GMP, Pharmaceutical Quality Systems, deviations, CAPA, change control, audits and risk management. Built to support sound interpretation, defensible decisions and stronger evidence.
ANALYSIS & PRACTICAL GUIDES
Quality systems, audit readiness and GMP processes explained through concrete criteria, examples and practical points of attention.
The automatic extension of GDP certificates granted during the COVID-19 emergency has ended. Regular inspections will resume in 2024, and new guidance on the role of the Responsible...
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GVP inspections require constant preparation. Discover the most critical areas and how our practical guides can help you create a PV Inspection Readiness Kit .
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The revision of EU GMP Annex 1 introduces stringent requirements for sterile production. Discover the key changes and how our operational guides can support manufacturing managers and QA.
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Good Laboratory Practice (GLP) ensures the quality and traceability of non-clinical data. Discover the fundamental principles, common errors, and how our operational guides can help laboratories achieve full...
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Operational Approach to GMP Cleaning Validation: MACO, Worst-Case, Sampling, and Non-Conformity Management
Operational Approach to GMP Cleaning Validation: MACO, Worst-Case, Sampling, and Non-Conformity Management
QP guidance on how to use Annex 16 and QRM (Annex 20) for audit-proof batch release, managing deviations, imports, and third-party audits.
QP guidance on how to use Annex 16 and QRM (Annex 20) for audit-proof batch release, managing deviations, imports, and third-party audits.
How to build an audit-proof monitoring plan (ISO 14644-2). Data management, alert/action, and the challenge of particles ≥5 µm (Annex 1 2022).
How to build an audit-proof monitoring plan (ISO 14644-2). Data management, alert/action, and the challenge of particles ≥5 µm (Annex 1 2022).
What Is Cleaning Validation GMP, What FDA and EMA Require, Common Errors, and the Impact on Quality and QA Careers
What Is Cleaning Validation GMP, What FDA and EMA Require, Common Errors, and the Impact on Quality and QA Careers
Practical EU GMP Annex 15 guide covering VMP, DQ, IQ/OQ/PQ, process validation, CPV, cleaning validation and the validated state.
Practical EU GMP Annex 15 guide covering VMP, DQ, IQ/OQ/PQ, process validation, CPV, cleaning validation and the validated state.
Operational guide to cleanroom qualification under ISO 14644-3:2019 and EU GMP Annex 1: HVAC tests, acceptance criteria, airflow studies, recovery and requalification.
Operational guide to cleanroom qualification under ISO 14644-3:2019 and EU GMP Annex 1: HVAC tests, acceptance criteria, airflow studies, recovery and requalification.
PRACTICAL GMP TOOLS FOR PHARMA
GuideGxP turns complex GMP requirements into operational guides, editable templates and practical insights for pharmaceutical professionals.
