An objectionable microorganism can be defined as
1) an organism that can proliferate in a product, adversely affecting the physical and therapeutic attributes of that pharmaceutical product, and
2) an organism that due to its numbers in the product and pathogenicity can cause infection in the patient when treated with that pharmaceutical product.
* The concept of objectionable microorganisms does not apply to sterile products where all organisms must be excluded from the product.
• It would apply to microbial testing of non sterile products, and the evaluation of microorganisms isolated in environmental monitoring and cleaning validation in non- sterile product manufacturing areas
Examples of clearly objectionable microorganisms for a drug product are:
– Pseudomonads that are capable of proliferation in the presence of common antimicrobial preservatives in a topical cream, nasal spray or oral liquid Fungal growth of the surface of a compressed tablet
– Food-borne bacterial pathogens such as Salmonella and Shigella species in an oral dosage form
– Fungal growth on the surface of a compressed tablet exposure in a blister to a high humidity environment
#1 Vander on 2011-03-27 05:04
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