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Ireland's HPRA Guidance: GDP Quality Systems, GXP Regulatory Advice, and Active Substance Registration Changes
The Health Products Regulatory Authority (HPRA) has released updated guidance documents to strengthen pharmaceutical quality systems, regulatory compliance, and operational oversight across Ireland’s healthcare sector. The updated guidance documents include: Guide to Quality System for General Sale Wholesale Distributors Guide to Pre-submission Scientific and Regulatory Advice for GXP Activities Guide to Managing Changes to Registrations of Active Substance Manufacturers, Imp
Sharan Murugan
6 days ago3 min read
Ireland HPRA’s Guide: Good Distribution Practice (GDP) of Medicinal Products
The Health Products Regulatory Authority (HPRA) of Ireland released Version 8 of its Guide to Good Distribution Practice (GDP) in March...
Sharan Murugan
May 3, 20253 min read
India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)
The Central Drugs Standard Control Organisation (CDSCO) in India has issued a draft guideline on Good Distribution Practices (GDP) for...
Sharan Murugan
Aug 20, 20242 min read
Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System
Yesterday (20 July 2023) Switzerland's Swissmedic released an updated guidance on "Harmonisation of the SwissGMP/GDP Inspection System"...
Sharan Murugan
Jul 21, 20232 min read