Host: The Japanese Society of Toxicology
Name : The 51st Annual Meeting of the Japanese Society of Toxicology
Date : July 03, 2024 - July 05, 2024
In pharmaceutical quality control, the 2018 PIC/S HBEL Guidelines1) stipulate the need to establish exposure limits (such as ADE and PDE) based on scientific assessment, in order to manage the exposure risk by cross-contamination in shared facilities. This requirement is also mentioned in the 2021 amended GMP Ministerial Ordinance in Japan. In the industrial hygiene, recent amendments of the Labor Safety and Health Act have shifted the management of chemical substances from specific regulations into autonomous management by individual companies. This has led to an obligation in the pharmaceutical industry to make efforts to reduce the exposure levels for workers.
PDE (Permitted Daily Exposure) is utilized to establish cleaning limits for manufacturing equipment, with the aim of reducing the health disorder risk of patients caused by contamination of the subsequent product with the previous product. On the other hand, OEL (Occupational Exposure Limit) is used in manufacturing pharmaceuticals (including APIs and other chemical substances) to select manufacturing and protective equipment, with the purpose of reducing the chemical exposure risk to workers.
In this presentation, I would like to introduce how PDE/OEL are actually utilized in the pharmaceutical industry.
1) Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
