Master Alliance Provisions Guide (MAPGuideⓇ)

Issue Introduction: Quality Management

Quality Management refers to provisions that define the standards, systems and oversight mechanisms that apply to the research, development, manufacture, testing, storage and distribution of medical products under an agreement. Quality management provisions are important because they help to ensure that products are safe, effective and manufactured consistently, and that there is sufficient visibility and assurance over the quality systems used by developers and manufacturers.

Questions to consider when developing quality management provisions

    • What are the quality management obligations for the development, manufacture and/or distribution of the product?

Example approaches found in the MAPGuide

Quality assurance obligations found in the MAPGuide provision database often include one or more of the following elements:

    • “Good Practice” standards: Developers or manufacturers may be required to follow good practice standards such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP, or cGMP), and Good Distribution Practice (GDP) (also collectively known as “GxP”) as applicable to the stage(s) of product development covered under the agreement. For some products, such as diagnostics or medical devices, agreements may require manufacturing in accordance with relevant ISO standards.
    • Regulatory authority quality standards: Developers or manufacturers may be required to manufacture finished products in compliance with the quality standards of the WHO Prequalification Programme (WHO PQ) or a WHO Listed Authority or Stringent Regulatory Authority (SRA). They may also be required to make undertakings not to sell or supply a product until approval has been obtained from the required regulatory authority(ies).
    • Environmental standards: In addition to good practice standards, some agreements require development and manufacturing to be conducted in compliance with applicable environmental and responsible manufacturing standards.
    • Quality agreements: Agreements involving joint development and manufacturing activities and/or technology transfer may refer to a separate quality agreement between the parties that sets out detailed responsibilities for matters such as quality control, batch release, stability testing, and project recalls.
    • Record-keeping and inspection: Some agreements require developers or manufacturers to maintain a documented quality management system that complies with applicable regulatory and industry standards, and to keep records demonstrating adherence to good practice standards. Agreements may also include requirements related to periodic internal audits of quality systems and/or the right for funders or licensors to conduct their own inspections.
    • Quality-related issues: Developers and manufacturers may be required to notify the other agreement party(ies) of any significant quality-related issues, such as major regulatory observations, suspension of GMP certification or serious product quality complaints.