GXP ACADEMY · GXP INSIGHTS
From GxP requirements to stronger quality systems.
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
Insights that turn compliance into action.
Quality systems, audit readiness and GMP processes explained through concrete criteria, examples and practical points of attention.
GxP Insights
Pharmacovigilance: Updates on risk minimization...
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 adapt internal...
Pharmacovigilance: Updates on risk minimization...
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 adapt internal...
Drug Traceability and Serialization: From the E...
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 track &...
Drug Traceability and Serialization: From the E...
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 track &...
EU pharmaceutical law reform: what's changing a...
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 key objectives,...
EU pharmaceutical law reform: what's changing a...
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 key objectives,...
Post-pandemic GDP: end of extensions and new gu...
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 Person will...
Post-pandemic GDP: end of extensions and new gu...
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 Person will...
Pharmacovigilance: How to Prepare for GVP Inspe...
GVP inspections require constant preparation. Discover the most critical areas and how our practical guides can help you create a PV Inspection Readiness Kit .
Pharmacovigilance: How to Prepare for GVP Inspe...
GVP inspections require constant preparation. Discover the most critical areas and how our practical guides can help you create a PV Inspection Readiness Kit .
Annex 1 EU GMP 2023: What's New for Sterile Man...
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.
Annex 1 EU GMP 2023: What's New for Sterile Man...
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.
