Scientific Director Healthcare, bioMérieux
Félix Alejandro MONTERO-JULIAN, Ph.D.
Data Integrity will always be important regardless if the production is for sterile or non-sterile products because accuracy of data can impact drug safety. Hence, reducing all human-related sources of error should be optimized independent from the facility type.
Identification of “objectionable microorganisms” is another topic that continues to be of importance for all drug types; including combination products such as nose sprays.
Consequently, the EM process including actions to improve data integrity, ensure the performance of culture media and any other action to optimize of the EM process should be no less importance than in sterile production sites.