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Increased Regulatory Scrutiny: Health-Based Exposure Limits to Ensure Patient Safety and Worker Protection

When involved in the manufacturing of pharmaceutical products, it isn’t just patient safety that needs to be at the forefront of industry’s mind, EU legislation on occupational welfare also requires derivation of safe health-based exposure limits for employee protection. However, the historically used arbitrary methods of calculating exposure limits are no longer acceptable to regulatory agencies. Companies are now expected to derive Permitted Daily Exposure (PDE) and Occupational Exposure Limits (OEL) based on toxicological evaluation.

ICH, EU GMP and EMA guidance recommends risk-based decision making and it is vital that companies get control measures in place, based on PDE, to limit cross-contamination in manufacturing facilities for the wellbeing of patients.

As highlighted by several inspection findings related to PDE, the UK national competent authority the MHRA are paying particular attention to this issue.

PharmaLex can support every aspect of your toxicological evaluation needs. Having prepared more than 500 PDE and OEL monographs to date, our Board certified and European Registered Toxicologist led team have extensive knowledge and in-depth understanding on various facets of toxicological risk assessment. With hands-on experience in experimental toxicology, the PharmaLex team offers support with the complex matters of cytotoxic, genotoxic compounds, hormones and high potent APIs and can provide a cost-effective service with swift turn-around times.

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For further information related to PDE, please refer to the following articles authored by our Board Certified and European Registered Toxicologist Principal Consultant, Director – Development Consulting and Scientific Affairs, Dr Sebastian Joseph.

As part of our toxicological services PharmaLex also offer:

  • Impurity qualification risk assessment
  • ICH M7 based mutagenicity evaluation
  • Computational toxicology (in silico) evaluations of impurities
  • Expert statement for justification of impurity specification
  • Extractable and leachable evaluation
  • Excipients evaluation and limit setting


The contents of this article/presentation are solely the opinion of the author and do not represent the opinions of PharmaLex GmbH or its parent AmerisourceBergen Corporation. PharmaLex and AmerisourceBergen strongly encourage readers/listeners to review available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto.

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