OTC AND PHARMACEUTICALS
UL protects the health of people and brands.
We deliver a broad spectrum of quality assurance programs to over-the-counter (OTC) and prescription drug manufacturers, helping them meet stringent demands for safety, effectiveness and quality.
The benefits of working with UL
The OTC and pharmaceutical industries are among the most heavily regulated industries in our global marketplace—people’s lives, health and comfort depend on the purity, potency and safety of OTC and prescription drugs. But increased recalls, along with heightened media and regulatory attention, can make it increasingly difficult for companies to maintain credibility and consistency.
UL’s expert staff of regulatory affairs consultants, microbiologists, chemists and human factors specialists provides the critical checks required to help protect public safety and brand reputation—from testing the purity and potency of raw material ingredients and finished products to verifying compliance with strict regulatory requirements, assessing a product’s use-safety and effectiveness, and measuring consumer acceptability.
We use recognized methods to test products for compliance to international, federal and regional regulations. The services we offer include pharmacopeia testing to U.S. Pharmacopeial Convention (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP) standards. We also provide compliance testing to U.S. Food and Drug Administration (FDA) current good manufacturing practices (cGMPs).
Our human factors engineering (HFE) advisory service helps product developers ensure the interactive quality of their products. Recent engagements have focused on:
- Lowering the risk of medication errors by making container labels more legible and packages easier to distinguish from each other
- Developing quick reference cards and instructions for proper drug reconstitution
- Conducting formative and summative usability tests to determine the use-safety and effectiveness of combination products
- Helping companies develop and implement HFE procedures as well as train their in-house personnel on HFE processes and design practices
Areas of Focus
Find the right service within the UL offering and learn how it meets your particular needs.
- Analytical Testing
- Chemical Testing
- Claims Testing
- Claims Validation
- Compliance Advisory Services
- Compliance Training
- Consumer Studies
- Custom Training
- Factory Capability and Quality Audits
- Human Factors Engineering Advisory Services
- Manufacturing Audits
- Microbiological Testing
- Package Review
- Physical Testing
- Process Validation
- Product Risk Assessments
- Program Development
- Quality Inspection
- Regulatory Testing
- Sensory Testing
- Supply Chain Certification
- Usability Testing
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