publicINFARMED · Portugal · Updated Sep 22, 2026
Revised Good Manufacturing Practice (GMP) Guidelines Issued in EudraLex - Volume 4
Regulatory and quality assurance teams should review and update relevant workflows, standard operating procedures (SOPs), and compliance controls to incorporate the new GMP requirements, focusing on the applicability dates and specific guidelines in the updated EudraLex - Volume 4.
Inspection ReadinessCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, PV Quality Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward