Consequences of the Guideline 98/8/EG and the Biocide Act for the pharmaceutical industry

GMP News
4 June 2008
 

Consequences of the Guideline 98/8/EG and the Biocide Act for the pharmaceutical industry

  
The implementation of the Guideline 98/8/EG in national Biocide Acts has been carried out in most member states of the European Union in the first two years of this century. But only today, with a quite long delay, the act yields consequences for many pharmaceutical manufacturers' disinfection concepts.

For older disinfectants (biocides) that were sold prior to 14 May 2000 manufacturers were granted a transition period regarding the notification for APIs and biocides. Biocides that were not submitted for approval according to the biocide act cannot be sold to consumers any longer after 2009. For that reason some products will not be available any more in the future, for others there will be changes in their formulation if single APIs are not registered. Both cases will require a re-validation or at least a change control process in the pharmaceutical production.

Frequently biocide manufacturers are not aware of this fact, simply because most of their customers like hospitals, nursing homes, contract cleaners and others do not need a validation of their disinfection systems. That's why often there's no information with regard to discontinuation or change of a disinfectant. For manufacturers with a validated disinfection system it is therefore recommended to request information on possible changes at the supplier of disinfectants.

The guideline itself can be downloaded as PDF at: http://ec.europa.eu/environment/biocides/pdf/dir_98_8_biocides.pdf

The guideline, annexes and further information can be found at http://ec.europa.eu/environment/biocides/index.htm

Author:
Axel H Schroeder
On behalf of the European Compliance Academy (ECA)
 

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