Slides

EU QUALITY AND GMP

  • Manufacturing Authorisation (MA) Responsibilities:

    • Ensure medicinal products are fit for intended use and comply with marketing authorization requirements.

    • Do not compromise patient safety through inadequate quality or efficacy.

    • Holders have a shared responsibility with management and staff commitment.

  • Pharmaceutical Quality System (PQS):

    • Encompasses Quality Management (QM) and Good Manufacturing Practice (GMP).

    • Must be appropriately designed considering company size and complexity.

  • PQS Objectives:

    • Achieve product realization with consistent quality attributes.

    • Manage product/process knowledge throughout lifecycle.

    • Ensure all manufacturing and control operations adhere to GMP.

    • Implement effective monitoring/control systems for process performance.

    • Conduct self-inspection/quality audits regularly.

  • Good Manufacturing Practice (GMP):

    • Concerns defined manufacturing processes, critical steps, documentation, and control measures throughout product lifecycle.

  • Quality Risk Management (QRM):

    • Systematic process for risk assessment and control linked to patient protection.

    • Stress importance of scientific knowledge and experience in evaluation.

  • ICH Guidelines:

    • Q8 (Pharmaceutical Development): Focus on quality by design (QbD) principles.

    • Q9 (Quality Risk Management): Outlines processes over the product lifecycle.

    • Q10 (Pharmaceutical Quality System): Supports drug substance/product quality maintenance.

WORLD HEALTH ORGANIZATION (WHO)

  • WHO Overview:

    • Directing authority on international health, providing health leadership, standards, and technical support.

  • Public Health and Medicine Regulations:

    • Ensure quality, safety, efficacy of medicines.

    • Monitor illegal activities and ensure rational drug usage.

  • Regulatory Support Role:

    • Development of norms/standards through various expert committees.

    • Provide technical assistance to aid countries in regulation.

  • Support Activities for Regulatory Authorities:

    • Assess regulatory systems, offer training, and develop regulatory models.

  • Capacity Building:

    • Enhance drug regulation through assessments and training courses.

  • Prequalification Program:

    • Ensures quality, safety, efficacy for essential medicines and vaccines.

  • Facilitation of Regulatory Information Exchange:

    • Develop tools for information sharing and convene international conferences for collaboration.


Substandard drugs pose significant challenges within healthcare systems worldwide. These challenges include:

  • Public Health Risks: Substandard drugs can lead to treatment failures and adverse health outcomes, increasing the risk of disease spread and resistance.

  • Economic Impact: The presence of substandard drugs undermines healthcare expenditure as patients may require additional treatments to address the complications arising from ineffective medications.

  • Erosion of Trust: The prevalence of substandard drugs can diminish public confidence in the healthcare system, leading patients to forgo necessary treatment.

To address these challenges, several solutions can be implemented:

  • Strengthening Regulatory Frameworks: Governments should enhance regulatory measures to ensure that drug manufacturing and distribution processes are strictly monitored and controlled.

  • Improving Supply Chain Transparency: Increasing transparency along the pharmaceutical supply chain can help identify and eliminate sources of substandard drugs.

  • Promoting Education and Awareness: Educating healthcare professionals and patients about the risks associated with substandard drugs can empower them to make informed choices and report suspicious medications.

  • Increasing International Cooperation: Collaboration among countries and organizations can facilitate better tracking and responses to counterfeit and substandard drugs.