PIC/S publishes two new documents on HBELs
On 1 June 2020, the PIC/S adopted the following two documents:
- PI 052-1 Aide Memoire Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management
- PI 053-1 Questions and Answers on Implementation of Risk-based Prevention of Cross-Contamination in Production and ‘Guideline on Setting Health-Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities’
The aim of the ten-page Aide Memoire is to assist inspectors in the inspection of health-based exposure limits (HBELs). The topics covered are HBEL assessment reports and quality risk assessment for cross-contamination control. The AiM in a checklist format refers to the relevant sections of the GMP guidelines and to Q&A 053-1. The document is of particular interest to all manufacturers who are preparing for an inspection and need to know the requirements of the inspectors.
The seven-page Q&A 053-1 was originally developed by the EMA and was adopted by PIC/S as a helpful document. With 13 question-answer pairs it supports the PIC/S Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PI 046).
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