15/16 February 2024
In the last newsletter you could already read about a new Aide-Memoire of the PIC/S for the inspection of health-based exposure limits (HBEL). At the same time, the PIC/S has published a Q&A document on HBEL and cross-contamination. What is behind this Q&A paper?
The Question and Answer document is called PI 053-1 and has the somewhat voluminous title "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'". This title may sound a little familiar. It is based on the 2018 EMA document of the same name and is intended to support the PIC/S document PI 046, which is also based on the EMA document on shared facilities and also supports the Aide-Memoire mentioned above. De facto, it is about the integration of these two EMA documents into the PIC/S system.
The topic of cross-contamination from the point of view of cleaning validation will be dealt with during an ECA Live Online Training Cleaning Validation on 3/4 September 2020.
You can find the documents on the PIC/S website, see PI 053-1.