This course derived from the work of the PDA objectionable microorganism task force covers the exclusion of objectionable microorganisms from non-sterile pharmaceutical drug products, over-the-counter drug products, medical devices, cosmetics and personal care products in the Pharmaceutical, Medical Device, Cosmetics and Consumer Healthcare Industries. Objectionable microorganisms, as cited in 21 CFR 211.113, are those microorganisms that, if they persist and grow in non-sterile products, can cause harm to the user of the products and degrade the physicochemical, functional and therapeutic attributes of the products. The contamination of marketed products with so-called objectionable microorganisms continues to be an infrequent but chronic problem for both regulators and our industry.
A recent U.S. survey of 144 recalls of non-sterile branded pharmaceutical drug products (5%), over-the-counter drug products (42%), cosmetics (31%), medical devices (14%) and dietary supplements (8% of the total recalls) for microbiologically-related issues between 2004 and 2011 highlighted that the majority of these recalls (72%) were associated with objectionable microorganisms.
The course will provide guidance on how to manage the microbial risks associated with objectionable microorganisms within a specific product that meet the microbial limits requirements for release to the market. A product that exceeds the limit with respect to microbial count and contains compendial specified microorganisms would be rejected. No definitive list of objectionable microorganisms will be provided in this course but microorganisms of potential concern will be highlighted from the literature concerning product contamination, infection outbreaks, product recalls, and the clinical experience with canonical pathogens and other opportunistic microorganisms at the site of administration of the non-sterile product. A risk-based approach will be taken because a microorganism isolated from a product cannot be considered objectionable without considering the product attributes, number of organisms as measured by colony-forming units (cfu), their potential pathogenicity, ability to grow in the product and the intended use of the product.
Risk mitigation including ingredient selection, the effect of unit manufacturing processes on product bioburden, environmental controls, product formulation, microbial specification setting, release and stability testing, risk assessment and product failure investigation will be highlighted using recent industry case histories.