New EMA Guideline on Specifications for Impurities in Antibiotics

In July 2012, the EMA published the final "Guideline on Setting Specifications for Related Impurities in Antibiotics" (EMA/CHMP/QWP/199250/2009) which is coming into effect one year after on 30 June 2013.

Antibiotics are manufactured by fermentation, or by fermentation with one or several further synthetic steps (semi-synthetic substances) or by chemical synthesis. Compared to synthetic processes, fermentation processes are more variable and less controllable.

The impurity profile of an API manufactured by fermentation may be more complex and less predictable than that of a purely synthetic product.

The ICH Guideline Q3 on impurities of APIs manufactured by chemical synthesis doesn't apply to fermentation products and semi-synthetic substances.

For this reason, the new guideline has been revised to fill in the gap regarding fermentation products and semi-synthetic substances.

The guideline sets thresholds for the reporting, identification and qualification of related impurities in antibiotics. Also the connection between the requirements in this guideline and the respective chapters and monographs in the European Pharmacopoeia is addressed.

The development of relevant specifications for APIs and finished products (including biotech products) will be one of the topics dealt with at ECA's Conference "Setting Specifications" on 26/27 November 2012 in Barcelona, Spain.

Please see the detailed EMA "Guideline on setting specifications for related impurities in antibiotics" for further information.