Quality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia Instruction
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 product...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Farname
2019-12-01
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| Series: | Iranian Journal of Medical Microbiology |
| Subjects: | |
| Online Access: | http://ijmm.ir/article-1-966-en.html |
| _version_ | 1798026850213036032 |
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| author | Aiesheh Gholizadeh-Hashjin farzaneh lotfipour Somayeh Hallaj-Nezhadi |
| author_facet | Aiesheh Gholizadeh-Hashjin farzaneh lotfipour Somayeh Hallaj-Nezhadi |
| author_sort | Aiesheh Gholizadeh-Hashjin |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T18:42:08Z |
| format | Article |
| id | doaj.art-70347b0c075d40e7b6fd5d577ad1e4ff |
| institution | Directory Open Access Journal |
| issn | 1735-8612 2345-4342 |
| language | English |
| last_indexed | 2024-04-11T18:42:08Z |
| publishDate | 2019-12-01 |
| publisher | Farname |
| record_format | Article |
| series | Iranian Journal of Medical Microbiology |
| spelling | doaj.art-70347b0c075d40e7b6fd5d577ad1e4ff2022-12-22T04:08:57ZengFarnameIranian Journal of Medical Microbiology1735-86122345-43422019-12-01135321345Quality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia InstructionAiesheh Gholizadeh-Hashjin0farzaneh lotfipour1Somayeh Hallaj-Nezhadi2 Food & Drug Control Department, Pharmacy Faculty, Tabriz University of Medical Sciences, Tabriz, Iran Food & Drug Control Department, Pharmacy Faculty, Tabriz University of Medical Sciences, Tabriz, Iran Food & Drug Control Department, Pharmacy Faculty, Tabriz University of Medical Sciences, Tabriz, Iran 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.http://ijmm.ir/article-1-966-en.htmlquality controlnon-sterile drug productsunited states’ pharmacopoeia |
| spellingShingle | Aiesheh Gholizadeh-Hashjin farzaneh lotfipour Somayeh Hallaj-Nezhadi Quality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia Instruction Iranian Journal of Medical Microbiology quality control non-sterile drug products united states’ pharmacopoeia |
| title | Quality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia Instruction |
| title_full | Quality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia Instruction |
| title_fullStr | Quality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia Instruction |
| title_full_unstemmed | Quality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia Instruction |
| title_short | Quality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia Instruction |
| title_sort | quality control of non sterile drug product according to united states pharmacopeia instruction |
| topic | quality control non-sterile drug products united states’ pharmacopoeia |
| url | http://ijmm.ir/article-1-966-en.html |
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