GxP Insights
ISO 14644 and GMP Annex 1: What is the real rel...
Confusing ISO 14644 with GMP Annex 1? We explain the relationship, the differences (Grades vs. Classes), and the critical management of particles ≥5 µm.
ISO 14644 and GMP Annex 1: What is the real rel...
Confusing ISO 14644 with GMP Annex 1? We explain the relationship, the differences (Grades vs. Classes), and the critical management of particles ≥5 µm.
Technological Innovations in Pharmacovigilance:...
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 use of...
Technological Innovations in Pharmacovigilance:...
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 use of...
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...