In the complex landscape of product manufacturing and regulatory compliance, quality deviations represent significant business and, in some cases, public health challenges. When manufacturing or other product related safety anomalies occur, organizations require rigorous scientific assessment to determine appropriate risk mitigation strategies and fulfill regulatory obligations.
Health Hazard Evaluations (HHEs) provide the analytical framework necessary for informed decision-making during these critical events.
Defining Health Hazard Evaluations in Regulatory Context
A Health Hazard Evaluation is a systematic, evidence-based assessment conducted to determine the potential health risks associated with product defects, manufacturing deviations or inherent safety issues with a properly manufactured product. The FDA defines this process as an evaluation conducted by an ad hoc committee of scientists that takes into account multiple factors:
- Whether any disease or injuries have already occurred from the use of the product
- Whether existing conditions could contribute to a clinical situation exposing humans or animals to a health hazard
- Assessment of hazard to various population segments (children, surgical patients, pets, livestock)
- Assessment of the degree of seriousness of the health hazard
- Assessment of the likelihood of occurrence of the hazard
- Assessment of the consequences (immediate or long-range) of occurrence of the hazard
Based on this determination, the FDA assigns recalls a classification (Class I, Class II, or Class III) to indicate the relative degree of health hazard.
Manufacturing and other safety related deviations requiring a Health Hazard Evaluation
SafetyCall provides expert assessment for determining the potential impact on safety and efficacy in various manufacturing deviations, including:
- Out-of-specification ingredients
- Inclusion of foreign materials
- Out-of-specification stability data
- Out-of-specification pH
- Contamination
- Product or ingredient related risk assessment, either pre- or post-market and independent of any suspected manufacturing breach
Each scenario presents unique risk characteristics requiring specialized toxicological and clinical expertise to determine health impact and guide appropriate organizational response.
SafetyCall's Distinguished Expertise in Health Hazard Evaluations
SafetyCall International's HHE consulting services are distinguished by depth of experience, breadth of data access, and recognized scientific and clinical expertise that positions us as industry leaders in product safety assessment.
Credentialed Multidisciplinary Team
SafetyCall's consulting group is composed of medical, veterinary, and toxicology specialists who are academically affiliated and internationally recognized experts in their fields. The team includes:
- Pharmacists
- Veterinarians board-certified in veterinary toxicology
- Physicians
- Basic Scientists
SafetyCall also maintains a network of external specialists that can be called upon in unique circumstances.
Comprehensive Consulting Services: An Integrated Approach to Product Safety
Health Hazard Evaluations represent one component of SafetyCall's comprehensive product safety
consulting services, which span the complete product lifecycle:
Product Research & Development
- Pre-market hazard and risk assessments
- Ingredient safety evaluations
- Formulation safety reviews for human and animal products
- Pet safety assessments
Manufacturing & Quality Assurance
- Manufacturing breach safety impact assessments
- Health Hazard Evaluation development for regulatory submission
- Product quality investigations affecting consumer safety
- GMP deviation risk assessment
Clinical Toxicology
- Individual and aggregate adverse event case evaluation
- Evidence-based relationship analysis
- Safety data and study review
- Adverse event signal detection and analysis
In-Market Surveillance and Support
- Adverse event incident investigation
- Safety issue management
- Risk communication strategy development
- Product-related poisoning prevention programs
- Expert witness testimony
- Merit analysis for product liability claims
Packaging & Labeling
- First aid and cautionary statement review
- Safety labeling compliance
- Package design consultation to minimize misuse risk
This integrated service portfolio enables SafetyCall to serve as a comprehensive resource throughout product development, commercialization, and post-market surveillance phases.
Commitment to Excellence and Safety
SafetyCall International's mission is to make the world a safer place by reassuring and providing quality care for clients, their customers, animals and pets by delivering immediate, 24/7 access to clear and trusted health, safety and medical information, and by enhancing and promoting product safety.
In an increasingly complex regulatory environment, access to credentialed expertise in Health Hazard Evaluation is essential for responsible product stewardship.
For consultation regarding Health Hazard Evaluations or comprehensive product safety services:
[email protected]
www.safetycall.com/consulting 
