PDE/HBEL Reports
Pharada provides scientifically justified Permitted Daily Exposure (PDE) and Health-Based Exposure Limit (HBEL) reports to support cleaning validation, cross-contamination risk assessment and GMP compliance in shared pharmaceutical manufacturing facilities.
A PDE establishes the amount of a substance that may be taken by a patient every day over a lifetime without presenting an appreciable health risk. The established value provides a scientific basis for defining cleaning limits and calculating Maximum Allowable Carryover (MACO).
A Standard Report Includes:
Active substance identification and relevant physicochemical information.
Review of therapeutic use, clinical data and route of administration.
Review of the available pharmacological and toxicological information.
Assessment of repeat-dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, acute toxicity and sensitization.
Selection of the relevant NOAEL, LOAEL or other point of departure.
Scientific justification of the applied adjustment factors.
Calculation of the final PDE value.
Scientific conclusion and supporting references.
Expert review and approval information.
How the Process Works
01 Submit Your Request
02 Confirm the Required Service
03 Receive the Quotation
04 Issue the Purchase Order and Complete Payment
05 Scientific Assessment and Report Preparation
06 Report Review and Finalization
The Information we Require from you:
Name of the active pharmaceutical ingredient.
Product name, dosage form and strengths, where applicable.
Route or routes of administration.
Therapeutic indication and maximum daily dose, if available.
Company name and address to appear in the report.
Required report type: PDE only or PDE with OEL.
Existing PDE, OEL or toxicological reports, if available.
The typical delivery time for a standard report is approximately 7-10 working days following payment and receipt of the complete required information. Larger batches or substances requiring additional scientific evaluation may require more time, which will be confirmed during the quotation stage.
Reports can also be updated or revalidated when new scientific data become available or when there are changes to the formulation, route of administration, manufacturing conditions or applicable regulatory requirements.
Contact Pharada to submit your list of active substances and receive a tailored quotation.
Address
401, 4th floor, Al Hazim Center
7 Yajouz Rd., Al Jubaiha, Amman
Get in Touch
+962 7 9805 8346
info@pharadaconsult.com
Sunday-Thursday: 9:00 AM – 5:00 PM (UTC+03:00)
