VALIDATION OF MICROBIOLOGICAL TEST METHODS .1. PHARMACOPEIA METHODS

To begin with, it is stated that analytical methods must be validated. This is not only true for chemical-analytical methods but also for microbiological test procedures. Even if these procedures present certain problems in validation due to the large deviation of the results, one should demonstrate that the methods are suitable for the intended use. In this part of the publication the validation of pharmacopoeia methods is described: sterility testing, colony counting and identification of certain bacteria. The methods are presently briefly and the practical validation is described. Special emphasis is placed on the documentation of the validation.