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).
> Do not hesitate, we look forward to your feedback!
Write a comment on this news.