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.
Operational guide to cleanroom qualification under ISO 14644-3:2019 and EU GMP Annex 1: HVAC tests, acceptance criteria, airflow studies, recovery and requalification.
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The 2023 revision of GMP Annex 1 introduces the Contamination Control Strategy (CCS). Learn what changes, the impact on QRM, and how to prepare your PQS.
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Confusing ISO 14644 with GMP Annex 1? We explain the relationship, the differences (Grades vs. Classes), and the critical management of particles ≥5 µm.
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European pharmacovigilance is undergoing a transformation thanks to new technologies: updates to EudraVigilance, the introduction of the Product Management Service (PMS), and the first EMA guidelines for the...
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The third revision of Module XVI of Good Pharmacovigilance Practices (GVP) came into force in August 2024. Learn what's new, the impact on pharmaceutical companies, and how to...
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Pharmaceutical traceability is now a global priority. From the European Anti-Falser Directive (DMF) to the US Drug Supply Chain Security Act (DSCSA), companies must adapt their serialization and...
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In 2023, the European Commission presented a proposal to reform pharmaceutical regulations, intended to transform access to medicines and the rules for companies in the sector. Discover the...
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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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Practical guide to conducting a GMP internal audit: audit plan and checklist, opening meeting, effective questions, evidence collection, time management and closing meeting. With ready-to-use examples.
Practical guide to conducting a GMP internal audit: audit plan and checklist, opening meeting, effective questions, evidence collection, time management and closing meeting. With ready-to-use examples.
Risk-based method to decide when E&L studies are required. Matrix, examples, audit-defensible criteria and focus on inspection expectations.
Risk-based method to decide when E&L studies are required. Matrix, examples, audit-defensible criteria and focus on inspection expectations.
How to build a risk-based annual GMP internal audit programme according to ICH Q9/Q10: audit universe, risk matrix, frequencies, independent auditors, KPIs and ready-to-use templates.
How to build a risk-based annual GMP internal audit programme according to ICH Q9/Q10: audit universe, risk matrix, frequencies, independent auditors, KPIs and ready-to-use templates.
How to build an effective Environmental Monitoring Programme: particles, microbiology, ΔP, alert/action limits, trending, data integrity and response to deviations.
How to build an effective Environmental Monitoring Programme: particles, microbiology, ΔP, alert/action limits, trending, data integrity and response to deviations.
How to build a robust cleaning & sanitisation programme: surfaces, frequencies, disinfectants, residues, special cleaning and audit readiness.
How to build a robust cleaning & sanitisation programme: surfaces, frequencies, disinfectants, residues, special cleaning and audit readiness.
How to perform an effective cleanroom Impact Assessment: technical factors, real examples, mitigations and integration with OCP/CCS.
How to perform an effective cleanroom Impact Assessment: technical factors, real examples, mitigations and integration with OCP/CCS.
PRACTICAL GMP TOOLS FOR PHARMA
GuideGxP turns complex GMP requirements into operational guides, editable templates and practical insights for pharmaceutical professionals.
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