Toxway determines Permissible Daily Exposure (PDE) Limits to ensure the safe presence of residual substances in drug products during manufacturing. These limits are scientifically derived thresholds based on toxicological risk assessments, establishing the maximum quantity of a residual compound that can be safely ingested daily over a lifetime without posing significant health risks. PDE limits are critical for maintaining patient safety, product integrity, and regulatory compliance.

Our PDE Services Include:

Comprehensive Risk Assessment:

We evaluate the toxicological profiles of substances to determine potential hazards, including studies on acute toxicity, chronic toxicity, carcinogenicity, and reproductive toxicity.

Data Compilation and Analysis:

Using scientific data from studies and available literature, we compile a robust dataset that allows for the accurate calculation of PDE limits based on the most relevant toxicological endpoints.

Guideline Compliance:

Our services align with ICH Q3C guidelines, ensuring that your PDE limits comply with international regulatory standards, such as those set by the FDA, EMA, and WHO.

Customized Solutions for Specific Manufacturing Processes:

Every manufacturing process is different, and we tailor PDE limit assessments based on the unique characteristics of your facility, drug formulation, and potential exposure sources, whether from solvents, excipients, or degradation products.

Cross-Contamination Prevention:

By establishing PDE limits, we also contribute to minimizing cross-contamination risks in multi-product facilities, helping you adhere to Good Manufacturing Practice (GMP) requirements.

Documentation and Reporting:

We provide detailed reports that outline the scientific basis for PDE limits, ensuring that your submission to regulatory authorities is comprehensive, transparent, and ready for approval.

Why PDE Limits Matter: Establishing accurate PDE limits is crucial to ensuring that trace amounts of residual substances, such as solvents or impurities, remain within safe limits, protecting consumers while maintaining regulatory compliance.

For more information about our services or to request a consultation, contact us at info@toxway.com