News about GMP/cGMP

04.06.2020

PIC/S publishes two new documents on HBELs

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). 


Sources: 

PIC/S News  

PI 052-1 Health Based Exposure Limit Aide-Memoire.pdf 

PI 053-1 HBEL QA.pdf 



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