Industry News

Data Integrity for Pharmaceutical Grade Excipients

In April 2020, IPEC released a position paper describing its position on the relevance of data integrity guidance documents to the manufacture and supply of excipients. "Maintaining data integrity is fundamental to the application of GMP. Published regulatory guidance...

read more

Remote Release and Remote Audits: New Answers from the EU

From ECA Academy The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing...

read more

Audit Trail Reviews of Electronic Health Records

Are You Managing Your Electronic Health Records Properly? According to the ECA Academy, MHRA inspectors have recently noticed several major findings during their inspections.  Issues have been noted with audit trails, access and security, scanning and certified...

read more

Audit Trail Reviews of Electronic Health Records

Are You Managing Your Electronic Health Records Properly? According to the ECA Academy, MHRA inspectors have recently noticed several major findings during their inspections.  Issues have been noted with audit trails, access and security, scanning and certified...

read more

Quality Requirements for Drug-Device Combinations

(From European Medicines Agency): Guidance is provided on dossier requirements for drug-device combinations (DDCs) in the context of a regulatory submission (marketing authorisation application and post-authorisation application). The types of DDCs within the scope of...

read more