Portable or handheld medicine screening technologies can help rapidly detect substandard and falsified medicines in the field. These devices support risk-based surveillance approaches and can help optimize resources by reducing the number of products requiring full quality control testing in a laboratory setting. However, rapid advances in screening technologies have left regulators with limited information how best to select, use, and deploy these tools. USP’s Technology Review program was established to rigorously evaluate available and emerging screening technologies and share our evaluation findings publicly to improve real-world implementation and use.
Our experience working with more than 40 medicine regulators and hundreds of quality control laboratories worldwide made it clear that regulators, inspectors, and quality control laboratories around the world need more information to make decisions about screening technologies.
USP invested in the Technology Review program, establishing a 13-member volunteer Expert Panel to provide technical guidance and oversight. Through the program, USP:
- Developed standards and guidelines for evaluating medicine quality screening technologies
- Generated and disseminated tailored information on the capabilities of these technologies through a two-step review process: a lab-based technical performance evaluation and a collaborative field-based utility evaluation
- Built the knowledge of key stakeholders to appropriately procure and sustainably deploy screening technologies for the purposes of combating substandard and falsified medicines
- Stimulated targeted investment in the development and enhancement of new screening technologies
USP Technology Reviews:
- Paper Analytical Device
- Target-ID review
- Speedy Breedy review
- CBEx Handheld Raman Spectrometer
- ASD QualitySpec® (Trek)
- Global Pharma Health Fund( GPHF)-Minilab™
Screening Technology Overviews: