ASTM E2500 APPROACH, Process Equipment Suppliers and Qualification SMEs
ASTM E2500 APPROACH, Process Equipment Suppliers and Qualification SMEs by Zoltan Langosco […]
Category: Technical Articles
New EU GMP Vol.4 Annex I and Environmental Monitoring leverage
New EU GMP Vol.4 Annex I and Environmental Monitoring leverage by: Alessio […]
Impact of possible removal of the Titanium dioxide from human medicines formulations was discussed during the CMDh meeting held on 14-17 September
Impact of possible removal of the Titanium dioxide from human medicines formulations […]
A comparison between CSV Guideline/regulations in Japan, India and China
A comparison between CSV Guideline / regulations in Japan, India and China
EU IVDR – Clinical Evidence and Performance Evaluation
EU IVDR – Clinical Evidence and Performance Evaluation by Andrea Colombo, MD […]
ICSR and Pharmacovigilance Data: Challenges for Pharmaceutical companies
Pharmacovigilance Data: challenges for Pharmaceutical Companies by: Daniela Rota PV Unit Manager […]
Critical Utilities GMP Compliance and new Annex 1
New Annex 1, among other important points considered, dedicates several comments on the importance and the impact of Critical Utilities, involved at different level either because directly impacting on Contamination Control Strategy (CCS) document, or because potential direct or indirect source of bio-contamination of the final product.
New EU GMP Annex 1: Implications for QRM application
New EU GMP Annex 1 – Implications for QRM application by Alessio […]
Covid-19 vaccines supply chain has become a target for cybersecurity attacks. How real is the threat?
Covid-19 vaccines supply chain has become a target for cybersecurity attacks. How […]
Smart Working: dealing with IT support implications
Smart Working: dealing with IT support implications by Dario Palese Current global […]