Pharma GMP News of the Week Oct 31 2021

Pharma GMP News of the Week: 30-October-2021

Period: October 24, 2021 to October 30, 2021

US, Canada, and the United Kingdom – Good Machine Learning Practice for Medical Device Development: Guiding Principles

Date of publication: October 27, 2021

According to FDA website, the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).

10 Guiding Guiding Principles are as follows:

1. Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Life Cycle

2. Good Software Engineering and Security Practices Are Implemented

3. Clinical Study Participants and Data Sets Are Representative of the Intended Patient Population

4. Training Data Sets Are Independent of Test Sets

5. Selected Reference Datasets Are Based Upon Best Available Methods

6. Model Design Is Tailored to the Available Data and Reflects the Intended Use of the Device

7. Focus Is Placed on the Performance of the Human-AI Team

8. Testing Demonstrates Device Performance during Clinically Relevant Conditions

9. Users Are Provided Clear, Essential Information

10. Deployed Models Are Monitored for Performance and Re-training Risks are Managed



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