【设定口服药品污染菌（不友好的）的限值】.pdfVIP

OPINION Setting Threshold Limits for the Significance of Objectionable Microorganisms in Oral Pharmaceutical Products Wireko Manu-Tawiah*, Beth Ann Brescia, and Eda Ross Montgomery Dupont Pharmaceuticals Company ABSTRACT : Due to the increasing number of immuno-compromised patients, increased attention is paid to the quantitation and identification of microorganisms in oral pharmaceutical products; therefore, a systematic approach is required by the manufacturers of non-sterile oral pharmaceuticals to evaluate the significance of microbial isolates other than primary pathogens and/or those in the product specification based on the number of organisms present, the type of dosage form, and the potential hazard to the user. Limits for objectionable microor- ganisms in oral products intended for use by immuno-compromised patient populations such as pediatric, HIV, cancer, etc., must be tighter than the limits for oral products intended for treating patients with diseases or condi- tions not affecting their immune systems because patients with deficient immune systems are more at risk of microbial infections. Smaller numbers of opportunistic pathogens become infectious when resistance mecha- nisms are impaired, either by severe underlying disease, or by use of immunosuppressive drugs. This article proposes a systematic approach for evaluating the significance of microbial isolates other than primary pathogens and/or those in the specification (e.g, Staphylococcus aureus and Pseudomonas aeruginosa) of non-sterile oral pharmaceutical products by setting appropriate threshold limits. Introduction adulterated in such a way that it would unacceptably degrade the product’s quality attributes or possibly com- In the last decade, the concern with objectionable mi- promise patient safet