year 13, Issue 5 (November & December 2019)                   Iran J Med Microbiol 2019, 13(5): 321-345 | Back to browse issues page

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Gholizadeh-Hashjin A, lotfipour F, Hallaj-Nezhadi S. Quality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia Instruction. Iran J Med Microbiol. 2019; 13 (5) :321-345
1- Food & Drug Control Department, Pharmacy Faculty, Tabriz University of Medical Sciences, Tabriz, Iran
2- Food & Drug Control Department, Pharmacy Faculty, Tabriz University of Medical Sciences, Tabriz, Iran ,
Abstract:   (4528 Views)
Pharmaceutical products are classified into two groups according to the microbiological point of view: 1) sterile products and 2) non-sterile products. The sterilized term refers to the products that are free of any microorganisms, their production were done under aseptic conditions, but the production of non-sterile products were not under aseptic conditions; therefore, they are not free from microorganisms; for this type of products legal authorities defined microbial limit ranges. The contamination of medicinal products by microorganisms can lead to adverse changes such as: change in physical attribute (appearance, color, smell, and viscosity), reduction of therapeutic effects, development of disease and ultimately the loss of consumer reliance. There have been reports about presence of unauthorized microorganisms in non-sterile medicinal products, which has led to more research and attention in this regard. In this paper, the methods for controlling the microbial quality of non-sterile drug products have been reviewed based on the latest version of United States’ Pharmacopoeia, including <61>, <62>, and <1111> general chapters that can be used as a reliable source for researchers in the pharmacy industry and drug control labs.
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Type of Study: Review | Subject: Industrial Microbiology
Received: 2019/09/24 | Accepted: 2020/01/2 | ePublished: 2020/01/10

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