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Preparation of High-Quality Fermented Fish Product
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What to consider for a good quality PDE document?

Claudia Sehner1, Markus Schwind2, Gregor Tuschl3

  • 1a Nonclinical Drug Safety , Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach an der Riss , Germany.

Pharmaceutical Development and Technology
|March 14, 2019
PubMed
Summary

The European Medicines Agency (EMA) now requires permitted daily exposure (PDE) values to limit cross-contamination in shared pharmaceutical facilities. This guidance helps ensure safe drug manufacturing by evaluating active pharmaceutical ingredients (APIs) and their critical effects.

Keywords:
Permitted daily exposure (PDE)active pharmaceutical ingredient (API)cross-contaminationshared facility

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Area of Science:

  • Pharmaceutical Science
  • Toxicology
  • Regulatory Affairs

Background:

  • Shared facilities for pharmaceutical production necessitate control of cross-contamination.
  • The European Medicines Agency (EMA) mandates permitted daily exposure (PDE) values for active pharmaceutical ingredients (APIs).
  • Unintended exposure to APIs can cause adverse effects in patients.

Purpose of the Study:

  • To provide guidance on establishing Permitted Daily Exposure (PDE) values for active pharmaceutical ingredients (APIs).
  • To outline considerations for evaluating the quality of PDE derivation documents.
  • To ensure safe handling of APIs and medicinal products in shared manufacturing environments.

Main Methods:

  • Structured scientific evaluation of API pharmacological activity and adverse effects.
  • Identification of the most critical effect for PDE calculation.
  • Review of available data for approved APIs for human use.

Main Results:

  • PDE setting requires a comprehensive assessment of API properties.
  • The most critical pharmacological or toxicological effect forms the basis for PDE calculation.
  • Guidance is provided for both setting PDEs and assessing third-party derivations.

Conclusions:

  • A systematic approach to PDE determination is crucial for pharmaceutical safety.
  • Accurate PDE values minimize risks associated with cross-contamination in drug manufacturing.
  • This publication supports regulatory compliance and enhances the quality of pharmaceutical production.