Examination of microbiological quality of pharmaceutical raw materials.

With the ICH harmonisation of the chapters 'Microbiological examination of non-sterile products: microbial enumeration tests' 'Test for specified micro-organisms' and 'Microbiological quality of pharmaceutical preparations' between Ph. Eur., USP and JP, altered specifications and test methods for pharmaceutical preparations are applicable in Europe since 2007 From this results the necessity to check and, where appropriate, adapt microbiological limit values in the individual monographs of the Ph. Eur.- provided that they contain such values. The present examination, which gives an evaluation of 3387 examinations in the period from 1997 to 2006 of the microbiological quality of 40 different pharmaceutical raw materials, is to provide a database for this purpose. It was shown that the existing limit values were not exceeded for 93% of the examined raw materials. 5.5% of the examinations were within the specification after using the valid tolerance factor of 5 of the old methods. Only 1.5% of all examinations led to OOS results. In comparison an evaluation of these data against the new, harmonised limits is leading to an increase in OOS results to a total of 6%. Most raw materials were of the required microbiological quality but a few, predominantly of plant origin, exceeded the limits. Regular incoming goods inspections are indispensable here.