HPRA Guide to Quality System for General Sale Wholesale Distributors

HPRA Guide to Quality System for General Sale Wholesale Distributors (September 2025):

• Purpose & Background

  • Provides minimum requirements for a Quality Management System (QMS) for wholesalers distributing medicinal products for general sale in Ireland.

  • Aligns with EU Good Distribution Practice (GDP) principles and HPRA’s risk-based inspection approach.

  • Updated in September 2025 to reflect:

    • Digitalization of quality systems (electronic records, validation requirements).

    • Risk-based inspection frequency (3–5 years based on compliance history).

    • Enhanced expectations for traceability, falsified medicines prevention, and supply chain security.

  Scope

  • Applies to general sale wholesale distributors holding a Wholesale Distribution Authorisation (WDA).

  • Covers storage, handling, and distribution of non-prescription medicinal products.

  • Excludes prescription-only medicines and controlled substances.

  Key Quality System Elements

  The guide specifies Standard Operating Procedures (SOPs) and controls required in a compliant QMS, including:

  1. Governance & Documentation

     • SOP for Responsible Person (RP) duties.

     • Document control, deviation management, and change control.

     • Management review and quality risk management framework.

  2. Operational Controls

     • Receipt, storage, and dispatch of medicinal products.

     • Temperature mapping and monitoring.

     • Cleaning, pest control, and waste management.

     • Transportation and branch-to-branch transfers.

  3. Compliance & Safety

     • Supplier and customer qualification.

     • Handling falsified medicines and recall procedures.

     • Complaint handling and self-inspections.

     • Outsourced activities oversight.

  4. Training & Competence

     • Mandatory training programs for all staff involved in GDP activities.

  5. Digital Systems

     • If using electronic QMS, validation or verification is required to demonstrate reliability and data integrity.

  Inspection Updates

  • HPRA now applies a risk-based inspection frequency:

    • Good compliance history → up to 5-year cycle.

    • Significant changes or poor compliance → shorter intervals.

  • On-site inspections focus on GDP adherence, falsified medicines prevention, and system robustness.

  Impact for Distributors

  • Must update SOPs to reflect:

    • Digital record-keeping and validation.

    • Enhanced supplier/customer verification.

    • Risk-based quality management.

  • Failure to comply may result in WDA suspension or revocatiod recommendations for forced degradation and confirmatory studies.