Freyr Records 450 HBEL Report Submissions in 2022
Freyr is pleased to announce the feat of submitting 450 Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) reports in 2022. The submissions also included the Occupational Exposure Limit (OEL) reports for more than thirty (30) global pharmaceutical companies.
- (1888PressRelease) January 25, 2023 - Acceptable Daily Exposure, Permitted Daily Exposure, Occupational Exposure Limit, Regulatory Affairs, PDE, ADE, GMP "Freyr is pleased to announce the feat of submitting 450 Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) reports in 2022. The submissions also included the Occupational Exposure Limit (OEL) reports for more than thirty (30) global pharmaceutical companies.
The ADE/PDE values are essential to determine the cleaning limits in the pharmaceutical cleaning validation process as per cGMP requirements. With the recommendation of the health-based exposure limit approach by EMEA and other Regulatory agencies, there is a huge demand for high-quality scientific ADE/PDE assessment reports in the pharma manufacturing world. Similarly, the OEL values help ensure the safety of the workers in pharma manufacturing. Derivation of the ADE/PDE and OEL values requires a very good understanding of pharmacology and toxicology, along with expertise in pharmaceutical risk assessment. Therefore, the EMEA and other Regulatory Agencies recommend scientific credentials and experienced toxicologists to be involved in the drafting and approval of ADE/PDE and OEL reports to ensure high quality and scientific interpretations in the most appropriate manner."
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