Testing for safety and quality of combination products, pharmaceuticals and biotech products
Quality assurance and transparency are essential for manufacturers of combination products (medical devices used in drug delivery), pharmaceuticals and over-the-counter (OTC) medicines. Companies must consider the safety and effectiveness of their products and how their products are stored, distributed and packaged.
Furthermore, combination product and pharmaceutical manufacturers must tightly control the dissemination of their products to ensure proper dosing and minimize risks of overdosing or dependency among patients.
Companies can also help avoid human error by developing intuitive combination product designs, clear and concise instructions for use and robust caregiver and patient support programs.
UL offers a comprehensive portfolio of services to support pharmaceutical, combination product and biotechnology companies address this vast array of business needs. We provide human factors engineering and usability testing for combination products, as well as testing and validation for packaging, potency and purity, quality assurance, and more.
Finally, UL collaborates with our experts to support point-of-care (POC) pharmaceutical security and supply chain best practices.
Usability testing and combination product design validation
For manufacturers of therapeutic and diagnostic combination products, minimizing the risk of human error is crucial for ensuring the safety and effectiveness of these products, especially in cases where patients self-administer therapies or medications.
UL’s human factors engineering (HFE) experts can help combination product manufacturers reduce user risks via:
- Early- to late-stage usability testing
- Guidance on design best practices for hardware, software and instructions for use
- Use-related risk analysis reporting
Packaging, storage and transportation
Packaging validation and stability testing for combination products, pharmaceuticals and OTC products are necessary for promoting safe storage, transport and distribution of products to healthcare providers and patients. UL provides packaging validation and stability studies for product transport and storage according to standards set by the International Safe Transit Association (ISTA), ASTM International and ISO 11607-1 for shelf-life. Our testing covers:
- Seal integrity
- Sterility and shelf-life
- Transportation and packaging system validation
- Air permeability
Testing for pharmaceutical and OTC products
For pharmaceutical and OTC product manufacturers, we offer potency and purity testing as well as pharmacopeial testing according to U.S. and international standards. These tests include:
- Potency, purity and impurity testing
- Microbiological testing
- Quality assurance
- Ingredient validation and label reviews
- Benchmarking analysis
- Testing to U.S. Food and Drug Administration (FDA) and other regulatory requirements