Glossary Term
Lot Release Testing
Definition
Lot release testing is a quality control process performed on a batch (or lot) of medical devices, pharmaceuticals, or biologics before they are released for distribution or use. This testing ensures that each lot meets predefined specifications for safety, efficacy, and compliance with regulatory standards. It involves sampling, testing, and documentation to confirm the consistency and quality of the product.
Relevance to the MedTech Industry
Lot release testing ensures that every batch of medical devices or components meets stringent quality and regulatory standards. It is critical for maintaining product reliability, patient safety, and compliance with regulatory requirements in a highly regulated industry.
Additional Information & Related Terms
Challenges or Considerations
Sampling StrategyA representative sample from each lot must be selected to ensure reliable results while minimizing product waste.
Regulatory ComplianceLot release testing must adhere to specific standards, such as FDA regulations, ISO 13485, or country-specific requirements.
Cost and TimeThorough testing can be resource-intensive, requiring advanced equipment, trained personnel, and strict timelines.
Test FailuresA failed lot release test may result in costly delays, product recalls, or additional investigations into manufacturing processes.
TraceabilityRobust documentation and traceability are required to link test results with the corresponding lot and manufacturing records.
Related Terms
Good Manufacturing Practices (GMP): Guidelines that govern the manufacturing and testing of medical products.
Quality Control (QC): Processes to ensure that products meet specific quality standards.
Sterilization Validation: Ensures that sterilization processes effectively eliminate microorganisms in medical devices.
ISO 13485: An international standard for quality management systems in medical device manufacturing.
Traceability: The ability to trace the history, application, or location of a product or batch.