GxP Insights
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.
Good Laboratory Practice (GLP): What They Are a...
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 compliance.
Good Laboratory Practice (GLP): What They Are a...
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 compliance.