,F-value Reports for Child-resistant Packaging (CRP)
Child-resistant Packaging (CRP) reduces child mortality/adverse effects from the unintentional ingestion of oral prescription drugs. CRPs are typically designed by modifying foil and blister materials, adhesives, blister pocket orientation, and wadding materials of container closure systems.
The “F” value, or Failure Value, is the count of drug units that can cause serious harm in a 25lb (11.4kg) child. For highly toxic drugs, “F” is usually set at F1, meaning a single unit is a failure. Less toxic drugs have higher “F” values, like F8. When a child gets access to a 9th unit, F8 restrictions are typically applied.
“F” value Calculation
F-values reports for CRP are calculated for a substance with multiple types of packaging (e.g. Blister, bottles, etc). Based on the derived F-value, the packaging is designed for the medicinal product.
“F” value Calculation process involves systematic collection and analysis of acute and repeated dose toxicity data along with adverse health effects observed in humans. In addition to this, clinical trial and post-marketing data in adults, pharmacokinetic (PK), and pharmacodynamics (PD) data are considered during data analysis. In the absence of substance-specific information, a read-across strategy using information from structurally or functionally similar compounds is used. Based on an overall assessment, a scientifically appropriate Point of Departure (POD) in terms of a numerical value is selected for 'F' value calculation. The "F" value typically ranges between 1 and 8.
F-value Reports for Child-resistant Packaging (CRP)
- ‘F-value’ calculation reports in compliance with the Electronic Code of Federal Regulations (E-CFR), Title 16 - Commercial Practices Chapter II - Consumer Product Safety Commission, and Poison Prevention Packaging: A Guide for Healthcare Professionals, U.S. Consumer Product Safety Commission.
- Regulatory knowledge and experience in the preparation of high-quality F-Value reports for simple to complex products.
- Reports submitted to several clients across the globe.
- Fast turn-around time
- Reports prepared by highly experienced and qualified toxicologists.
- Reports reviewed and approved by certified toxicologists.
- Robust quality control checks, right from document compilation to sign-off.
- Flexibility to adapt to customer-specific templates and requirements like priority delivery of reports within the shortest time.
- Regulatory/health authority query responses related to F value.
