Pharmeuropa - Comments concerning revised texts about Bacterial Endotoxins

As mentioned in the GMP News "EDQM revises 5.1.10. Guidelines for using the Test for Bacterial Endotoxins" from November 2014, the EDQM published a revised draft of that chapter which was open for comments. Now the EDQM issued an overview with "Comments concerning revised texts published in Supplement 8.8" - amongst others concerning the changes in chapter 5.1.10. The EDQM summarized as follows:

"This general chapter has undergone a general revision with the following scope:

  • In the context of the new bacterial endotoxins Ph. Eur. policy approved by the European Pharmacopoeia Commission during its 149th Session (June 2014), a section has been added (section 2-4) to include aspects to be considered when establishing an endotoxin limit for a specific substance or product; also, the text has been revised to reflect the fact that an endotoxin limit is not always provided in a specific monograph.
  • Reference is made to general chapter 2.6.30. Monocyte-activation test as an alternative to the rabbit pyrogen test, and a recommendation is given to perform a risk assessment when using the bacterial endotoxin test as a pyrogenicity test, due to the potential for contamination by non-endotoxin pyrogens. In this respect, the previous section 11 concerning the replacement of the rabbit pyrogen test by a test for bacterial endotoxins has been substituted with a new text in agreement with a strategy to be applied for testing of bacterial endotoxins or non-endotoxin pyrogens. A distinction is made between replacement methods already described in the Ph. Eur. and other alternative methods.
  • Reference is made to the use of alternative reagents to the Limulus amoebocyte lysate, such as recombinant factor C: this practice avoids the use of animal species and can be considered in the context of the use of an alternative method as described in the General Notices.

A number of additional specific points have been included in the revision:

  • Method A is no longer declared as the reference method, and all methods A to F of general chapter 2.6.14. Bacterial endotoxins can be used. Where the method is stated in the monograph, the use of another method must be validated.
  • The expression ‘threshold endotoxin concentration’ has been replaced by the more appropriate expression ‘endotoxin limit concentration’ to harmonise with general chapter 2.6.30. Monocyte-activation test.
  • A new entry has been included in Table 5.1.10.-1 for formulations administered per square metre of body surface.

Finally, the structure of the general chapter has been modified to improve its clarity."

Additionally they announced, that the chapter 2.6.8. now includes a reference to 2.6.30. Monocyteactivation test as a potential replacement of the test for pyrogens.

For the complete overview please see "Comments concerning revised texts published in Supplement 8.8". The online version can be accessed on the website of EDQM. Access to the online version requires registration, but this is a free service.

Please be aware of ECA's special activity related to the current issue of Endotoxin Masking - see the hands-on laboratory course "Low Endotoxin Recovery/Masking" on 10 and 11 February 2016 in Bernried near Munich, Germany.

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