Good Machine Learning Practice (GMLP)

Artificial Intelligence (AI) and Machine Learning (ML) technologies are transforming the life sciences landscape, driving innovation across drug discovery, clinical research, manufacturing, and patient safety. However, as these systems grow in complexity and influence, so does the need for a structured, compliant approach to their design, verification, validation, and governance.

The U.S. Food and Drug Administration (FDA), through its ongoing AI/ML initiative, emphasizes the application of Good Machine Learning Practice (GMLP) to ensure that AI-based systems used in regulated contexts meet standards of safety, efficacy, reliability, and transparency.

We bridge the gap between digital innovation and regulatory assurance, applying our established expertise in Part 11, Annex 11, and GAMP 5 to the evolving world of AI/ML.

ProPharma's Framework for AI/ML Quality and Compliance

ProPharma approaches AI/ML compliance under the same disciplined structure that governs all GxP systems but is enhanced to address the unique learning and adaptability of AI models. Our methodology integrates Good Machine Learning Practice (GMLP) principles into each lifecycle phase:

Design and Digital Blueprinting

• Define the system's intended use, data sources, learning models, and decision boundaries.
• Develop a Digital Blueprint, traceable record mapping algorithmic behavior, model explainability, and performance requirements for intended regulatory outcomes.
• Establish design controls consistent with FDA design control (21 CFR 820.30) and Annex 11 Section 4 expectations.

System Selection and Risk Assessment

• Evaluate commercial or custom AI/ML systems for suitability, data governance maturity, and algorithm transparency.
• Apply risk-based assessment per GAMP 5, ensuring controls are proportional to system impact on product quality, patient safety, and data integrity.

Verification and Qualification/Validation

• Conduct algorithm verification against design requirements, including model accuracy, bias testing, and robustness.
• Validate under intended use conditions to demonstrate consistent performance and compliance with Part 11 electronic record/e-signature requirements.
• Document validation following IQ/OQ/PQ principles and ensure traceability to system requirements.

Implementation and Change Governance

• Implement within a controlled environment ensuring cybersecurity, version control, and audit trail functionality.
• Establish a predetermined Change Control Plan framework, anticipate future model updates, retraining events, and change review mechanisms.
• Define governance processes that allow continuous model learning while maintaining regulatory control.

Quality Governance and Lifecycle Management

• Integrate AI/ML oversight into existing Quality Management Systems (QMS), covering vendor oversight, data management, periodic review, and deviation management.
• Establish a GMLP Review Board, a multidisciplinary team that assesses model drift, performance metrics, and change justification.
• Maintain comprehensive documentation aligned with Annex 11, Part 11, and GAMP 5 expectations for electronic systems.

ProPharma: Where Innovation Meets Compliance

AI and ML represent the next frontier in digital transformation for life sciences. Yet, success demands more than technical innovation; it requires compliance by design.

By combining FDA's GMLP principles with ProPharma's deep experience in GxP, Part 11, Annex 11, and GAMP validation frameworks, sponsors can confidently deploy AI systems that are not only cutting-edge but regulatory strong.

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Expertise and Support

ProPharma is your international, independent, single-source partner for expert insights pertaining to technical, quality compliance, and regulatory assistance throughout the product lifecycle. With over 2,500 employees, we have one of the largest compliance consulting groups in the world. When you partner with ProPharma, you gain the experience of the entire company, not just the team assigned to your project.

Global Reach

With offices and auditors located worldwide, ProPharma Group offers the ability to execute audits across different GxP areas of interest globally, creating efficiencies in both time and money. We have a large team of experienced auditors, with different areas of expertise, language skills, and cultural orientation. All auditors are fluent in English and many of our auditors are also fluent in at least one other language.

Breadth of Expertise

Our consultants have extensive audit and operational experience in at least one GxP specialty (GMP, GDP, GVP, GCP, GLP, and/or IT/CSV) and often in multiple areas of expertise.

Inspection Readiness

We ensure that every step towards Inspection Readiness is carefully calibrated to your needs. Our method is backed by tangible tools and training programs developed from the ground up, tailored not just to your product but to your organization's unique scale and scope. This approach allows you to focus on running your business while we dedicate ourselves fully to your Inspection Readiness, making it our singular priority.