28/29 April 2021
The EU Commission had published its first draft of the chapter 3 "Premises and Equipment" and 5 "Production" for comments in early 2013 (see news from 04/12/2013). The content concerns the measures for avoiding cross-contamination and the regulation relative to which products have to be produced in dedicated facilities.
The mention of specific products for which a dedication is required - as provided in the currently valid version of chapter 3 - is missing in the now published version. The quality risk management approach is maintained. Also remaining are the exceptions where dedication is required - which are:
But the main difference to last year's draft version is that there is no referencing for how the repeatedly mentioned toxicological assessment has to be done. The last draft for this purpose referenced the EMA Guideline (setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities), which is still in draft stage and is subject of controversial discussions. This of course creates new liberties. At the same time, though, it generates just as much uncertainty what such a toxicological assessment has to look like after all to be accepted by the authority. Chapter 5.20 provides some indications with regard to how the decision process has to be done risk-based and scientifically formal. Concrete information on the toxicological risk classification or derivation of the limit cannot be found here.
To find the new Chapters valid from 1 March 2015 please see