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Medicines quality testing and surveillance

Caribbean Member States rely on laboratory services to verify the quality of medicines available on the market. When there is a need to assess product quality—such as during routine surveillance, post-market monitoring, or investigation of suspected quality issues—samples are collected at national level and sent to the CARPHA Medicines Quality Control and Surveillance Department (MQCSD). MQCSD performs specialised laboratory testing under an accredited quality management system (ISO/IEC 17025) and provides validated results to national authorities.

These results support regulatory decisions such as recalls, further investigation, or continued use of the product. Laboratory findings may also be linked to product information in the regional registry, providing a more complete view of product quality across the region.

This use case illustrates how a cross-border healthcare architecture supports quality assurance by enabling the exchange of laboratory data, coordination of testing activities, and integration with regulatory processes.

Challenge today

  • Complex logistics for cross-border sample transport
  • Fragmented laboratory data across countries
  • Delays in receiving and acting on test results
  • Limited integration between laboratory and regulatory systems
  • Inconsistent linking of test results to product information

Desired situation

  • Efficient coordination of sample submission and testing across countries
  • Laboratory results are shared digitally and linked to products and batches
  • Timely access to quality data for regulatory decision-making
  • Improved regional visibility of medicine quality issues
  • Strong integration between laboratory and regulatory processes

Required capabilities

  • Identification and tracking of samples and batches
  • Secure exchange of laboratory data and results
  • Standardised formats for laboratory testing and reporting
  • Integration between laboratory and regulatory systems
  • Traceability of testing processes and outcomes
  • Product / Batch Identity
  • Laboratory Information Exchange
  • Health Data Exchange
  • Terminology & Semantics
  • Audit & Logging

Impact

  • Improved detection of substandard or counterfeit medicines
  • Faster regulatory response to quality issues
  • Strengthened laboratory collaboration across the region
  • Better protection of public health
  • More efficient use of specialised laboratory capacity