I would like to use recombinant factor C (rFC), do I need to perform a validation?

Answer:

rFC was introduced in general chapter 2.6.14. Bacterial endotoxins and, as of the publication of the revised general chapter in Issue 13.1 (April 2026, with an implementation date of 1 January 2027) will be fully integrated as one of the seven official methods available for bacterial endotoxin testing. (See the publication schedule of the Ph. Eur.)

As indicated in the General Notices, the analytical procedures given in monographs have been validated in accordance with accepted scientific practice and recommendations on analytical validation. Unless otherwise stated in the monograph, users are not required to validate these procedures.

When implementing a Ph. Eur. analytical procedure, users must assess whether and to what extent its suitability under the actual conditions of use needs to be demonstrated according to relevant monographs, general chapters and quality systems.

In case of the use of rFC for bacterial endotoxin testing (method G of 2.6.14 as of 1 January 2027), the only verifications you will need to perform are those described in the chapter itself under Preparatory testing.