quality assurance - qualified person

Overview of Medicine Design & Manufacture (MDM)

  • Quality: Defined as fitness for purpose.

  • Quality Assurance (QA), Good Manufacturing Practices (GMP), and Quality Control (QC) are interconnected.

  • Awareness of various GxPs that apply to medicine development and manufacture is crucial.

  • Documentation is essential for maintaining QA.

Topic Aim

  • Understand the role of Regulation and Quality Assurance systems in licensing medicines.

  • Learn about:

    • The medicine design and manufacture cycle.

    • Different types of quality systems.

    • Regulatory authorities globally.

Learning Objectives

  • Grasp the role and responsibilities of a Qualified Person (QP).

  • Identify types of licenses for manufacturing and distributing medicines.

  • Discuss the purpose of a manufacturer's license and the process to obtain it.

  • Explain the marketing authorization process and the experts involved.

The Qualified Person (QP)

  • Regulatory Basis:

    • Human Medicines: Directive 75/319/EEC

    • Veterinary Medicines: Directive 81/851/EEC

  • Qualifications:

    • Demonstrated competence.

    • Sufficient relevant experience as assessed by relevant authorities (RSoB, GPhC, RSC, MHRA).

Responsibilities of a QP

  1. Approval and Compliance:

    • Approves batches for sale/supply and ensures compliance with manufacturing standards.

    • Imported batches must be fully tested to confirm compliance unless equivalent standards are agreed (EU).

    • Maintain appropriate registers of approved batches.

  2. Documentation & Validation:

    • Ensure compliance with Marketing Authorization and Manufacturing Authorization.

    • Verify adherence to GMP and critical processes validated.

    • Completion of Batch Manufacturing Records (BMR) and Batch Production Records (BPR) review.

  3. Investigations:

    • Manage recalls and compliance issues, including investigations of organizations or QPs involved.

    • Involvement in potential disciplinary actions and professional misconduct charges.

    • Act as regulatory bodies' representative within pharmaceutical organizations.

Drug Development Cycle

  • Stages:

    • Research: Discover compound through pharmacological action determination.

    • Pre-Clinical Development:

    • Formulation development (liquids, suspensions, capsules, parenterals).

    • Conduct toxicology, biopharmaceutical, and stability studies.

    • Clinical Development Phases:

    • Phase I: Trials with healthy volunteers.

    • Phase II: Trials with patients.

    • Phase III: Larger scale patient trials.

    • Phase IV: Post-marketing surveillance.

  • Preparation of Marketing Authorization Application (MAA) by Regulatory Affairs.

Marketing Authorisation (MA)

  • Definition: Document permitting the marketing of a medicinal product.

  • Formerly Known As: Product Licence.

  • Purpose: To ensure quality, safety, and efficacy of medicines.

  • Submission Format: Common Technical Dossier (CTD).

  • Duration: Valid for 5 years.

Participants in the Licensing Process

  • Pharmaceutical Companies: Regulatory Affairs department, experts in pre-clinical, quality, and clinical fields.

  • Regulatory Authorities: Engage assessors and advisory bodies (like CHM).

Role of the Regulatory Affairs Department

  • Present registration documents to regulatory agencies and negotiate for marketing authorization.

  • Provide strategic and technical advice throughout product development.

  • Monitor changes in legislation across distribution regions.

  • Assess legal/scientific restraints, and gather scientific data.

  • Participate in product marketing strategies, including packaging and advertising approvals.

Common Technical Dossier (CTD)

  • Modules:

    • Module 1: Includes administrative information (not part of CTD).

    • Module 2: Overall quality summary.

    • Module 3: Non-clinical and clinical overview and quality summaries.

    • Modules 4 & 5: Detailed reports of clinical studies.

Types of Licences in Pharmaceutical Manufacturing

  • Manufacturer's Licences:

    • MIA for Investigational Medicinal Products (IMPs).

    • Specials Licence for non-standard products.

    • Hospital exemption licence for advanced therapy products.

    • Various licenses for veterinary products.

Conclusion

  • Quality products are vital for enhancing lives while poor-quality products can result in severe consequences.

  • Quality Assurance is critical for the survival of companies and the safety of consumers.

Questions

  • Reminder: Directed study content is examinable.