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๐Ÿ“ฌ Connexo Quality Newsletter Vol. 29 | June 2025
๐Ÿ“ฌ Connexo Quality Newsletter          Vol. 29 | June 2025

1.   Event Announcement 

PQM 2025 First Half Spring Academic Seminar

๐Ÿ—“๏ธ Date: Friday, June 27, 2025, 2:00 PM (Registration from 1:00 PM)
๐Ÿ“ Venue:
Hotel Square Ansan (formerly Hotel Square by Savills)
๐Ÿ“Œ Ballroom:
Grand Ballroom, 2nd Floor
๐ŸŒ Hotel Info |
โ˜Ž 031-490-2000

๐ŸŽค Topics & Speakers:

  1. CCS Case Study
    ๐Ÿ”น Jusung Park, Team Leader – Hanmi Pharmaceutical
  2. Warning Letter Case Study: Data Integrity
    ๐Ÿ”น Seunghoon Lee, Deputy General Manager – Waters Korea
  3. Case Analysis: GMP Consultation & Compliance Measures
    ๐Ÿ”น Minki Kim, Officer – MFDS, Gyeongin Regional Office, Drug Inspection Division
  4. Recent Major GMP Violations
    ๐Ÿ”น Hyunji Kim, Officer – MFDS, Gyeongin Regional Office, Product Safety Division

Join us to explore real-world quality challenges and up-to-date regulatory insights.

2. Regulatory Updates

๐Ÿ“ Ireland’s HPRA Releases New GDP Guide Update

The Health Products Regulatory Authority (HPRA) of Ireland has published an updated version of its Good Distribution Practice (GDP) guide, introducing heightened expectations and clarifications across core operational areas.

The revised guide strengthens compliance requirements in the following areas:

  • Temperature monitoring systems – Enhanced expectations for equipment calibration, continuous monitoring, and excursion management
  • Transportation risk assessment – Detailed guidance for evaluating supply chain vulnerabilities during transit
  • Broker oversight and documentation – Clearer requirements for ensuring broker compliance with GDP and maintaining robust records

The guide also provides expanded and updated instructions across the following chapters:

  • Chapter 1 – Quality Management
  • Chapter 2 – Personnel
  • Chapter 3 – Premises and Equipment
  • Chapter 4 – Documentation
  • Chapter 5 – Operations
  • Chapter 6 – Complaints, Returns, Suspected Falsified Medicinal Products, and Recalls
  • Chapter 7 – Outsourced Activities
  • Chapter 8 – Self-Inspections
  • Chapter 9 – Transportation
  • Chapter 10 - Specific Provisions for Brokers

๐Ÿ”— Read the full article at GMP Compliance

3. TrackWise/ TrackWise Digital – Spring ’25 Highlights

The Spring 2025 release delivers meaningful upgrades across modules:

๐Ÿ”น Document Management
• Renumber existing document records
• Reset numbering conventions for legacy documents

๐Ÿ”น Artificial Intelligence
• CAPA Evaluator enhancement
• Semantic insight mapping
• Consolidated AI metrics dashboard

๐Ÿ”น TrackWise Digital Platform
• Family Tree support in QPAs
• Improved child record lookups
• Built-in translation for workflow status and actions

๐Ÿ”น Complaint Management
• Improved usability and responsiveness of eMDR forms

๐Ÿ”น Training Management
• Delay training assignments based on prerequisite training status
• Configure and print training certificates

๐Ÿ”น TW on Prem
• Tech Stack Upgrade


๐Ÿ“ฉ Inquiries & Demo Requests:

[email protected] / www.connexo.io