17/18 March 2020
The issue of cross-contamination has been addressed by authorities since the publication of the first edition of the EU GMP Guidelines. The finalisation of the EMA "Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" has started a new chapter on cross-contamination. Health-based exposure limits (HBEL) and Permitted Daily Exposure limits (PDE) have been in the focus ever since. Subsequently, chapter 5 of the EU GMP Guideline (Part I) and Annex 15 regarding cleaning validation have both been revised. A draft and now the final version of a Question and Answer document on "Shared and Dedicated Facilities" has been published, as well.
The EMA has compiled documents covering the issue on their website:
The first and the last document are interesting, especially. On 96 pages, the first document lists the industry's comments on the Question and Answer (Q&A) draft document on the "shared facility" guideline. The last document includes several sets of lecture slides by authority and industry representatives on the issue of health-based exposure limits.
You may find the collection on the EMA's website.
If you are interested in HBEL and PDE, the webinar "EMA´s Q & A regarding PDE-values" on 17 October, 2019 might be interesting for you.