Quality Control of Non-Sterile Drug Product According to United States Pharmacopeia Instruction

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Gholizadeh Hashjin Aiesheh; LOTFIPOUR FARZANEH; Hallaj Nezhadi Somayeh

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Title

Quality Control of Non-Sterile Drug Product According to United States Pharmacopeia Instruction

Author(s)

Gholizadeh Hashjin Aiesheh | LOTFIPOUR FARZANEH | Hallaj Nezhadi Somayeh | Issue Writer Certificate

Keywords

Quality controlQ1

Non-sterile drug productsQ1

United States PharmacopoeiaQ1

Abstract

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 is done under aseptic conditions, but the production of non-sterile products is not under aseptic conditions and therefore, they are not free of 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 (USP), 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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APA: Copy

Gholizadeh Hashjin, Aiesheh, LOTFIPOUR, FARZANEH, & Hallaj Nezhadi, Somayeh. (2020). Quality Control of Non-Sterile Drug Product According to United States Pharmacopeia Instruction. IRANIAN JOURNAL OF MEDICAL MICROBIOLOGY, 13(5 ), 321-345. SID. https://sid.ir/paper/377739/en

Vancouver: Copy

Gholizadeh Hashjin Aiesheh, LOTFIPOUR FARZANEH, Hallaj Nezhadi Somayeh. Quality Control of Non-Sterile Drug Product According to United States Pharmacopeia Instruction. IRANIAN JOURNAL OF MEDICAL MICROBIOLOGY[Internet]. 2020;13(5 ):321-345. Available from: https://sid.ir/paper/377739/en

IEEE: Copy

Aiesheh Gholizadeh Hashjin, FARZANEH LOTFIPOUR, and Somayeh Hallaj Nezhadi, “Quality Control of Non-Sterile Drug Product According to United States Pharmacopeia Instruction,” IRANIAN JOURNAL OF MEDICAL MICROBIOLOGY, vol. 13, no. 5 , pp. 321–345, 2020, [Online]. Available: https://sid.ir/paper/377739/en

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