Why are PDE & HBEL Reports Required?

PDE and HBEL reports are required to establish scientifically justified, health-based exposure limits for pharmaceutical ingredients. These limits are critical for:

• Risk Assessment: Protecting workers in pharmaceutical production facilities by ensuring that their exposure to substances does not pose a risk to health.
• Cross Contamination Prevention: Guiding the implementation of adequate safety measures to prevent cross-contamination between different pharmaceutical products.
• Regulatory Compliance: Meeting regulatory requirements set by authorities such as the EMA and FDA, which mandate the evaluation of occupational and patient exposure risks.

How are These Reports Prepared?

Preparing PDE and HBEL reports involves a rigorous scientific process:

• Toxicological Evaluation: Conducting a thorough review of all available pharmacological and toxicological data on the substances, including non-clinical and clinical study results.
• Data Analysis: Using this data to assess the adverse effects and determine safe exposure levels based on standard calculation methods.
• Documentation: Compiling the findings into detailed reports that outline the methodologies used, data considered, and the rationale behind the established exposure limits.

What is Included in These Reports?

Each PDE and HBEL report includes:

• Substance Identification: Detailed information about the pharmaceutical substance evaluated.
• Toxicological Data Summary: A comprehensive summary of the toxicological data used in the assessment.
• Exposure Limit Calculations: Detailed descriptions of how the exposure limits were calculated, including safety factors applied.
• Risk Management Recommendations: Guidelines for managing the risk of exposure in manufacturing and handling processes.

Why Choose PharmaGXP for Your PDE & HBEL Report Requirements?

PharmaGXP provides PDE and HBEL reporting services through our EU and UK registered toxicologists, ensuring that every report is genuine and authenticated.

Clients can trust PharmaGXP to deliver high-quality, reliable reports that meet both their safety standards and regulatory requirements.

With our expert team, you can ensure that your pharmaceutical products are manufactured within the safest possible parameters, protecting patients.