The microbiological attributes of the drug product should be discussed. The discussion should include:

1 The rationale for performing or not performing microbial limits testing for non sterile drug products 2 The selection and effectiveness of preservative systems in products containing antimicrobial preservative or the antimicrobial effectiveness of products that are inherently antimicrobial; 3 For sterile products, the integrity of the container closure system as it relates to preventing microbial contamination.