This article aims to review available scientific data dealing with the Microbial contamination that may occur by some environmental factors (temperature, pH, and water activity), these factors are a major problem for the spoilage of pharmaceutical dosage form, and raw material, personnel, and other factor contributing to the transfer of the microbe into the pharmaceutical product. Non-sterile oral pharmaceuticals, including syrups, do not need to be sterile. At the same time, certain quality-control tests and some measures were followed, according to current good manufacture practice (cGMP), which are essential to keep the microbial content of these preparations safe and acceptable. Similarly, may manufacturer failures to comply with the Good Manufacturing Practice (GMP) at any stage of pharmaceutical production may consequently affect the microbiological quality of the product, and ultimately they caused economical loss for industrialists on the spoilage of pharmaceuticals. Microbial contamination in the pharmaceutical products increases from prescribed limits may change their Physico-chemical properties of the dosage form may be chances to hazardous for the immune-compromised patient due to overload microbial contamination. All the components of the non-sterile pharmaceuticals such as API and all kinds of excipients are at risk due to microbe overloaded and spoilage. Strictly the following (cGMP), continuous pharmaceutical surveillance is required to control microbial contamination within the pharmaceutical preparations.
| Published in | Pharmaceutical Science and Technology (Volume 5, Issue 2) |
| DOI | 10.11648/j.pst.20210502.17 |
| Page(s) | 68-75 |
| Creative Commons |
This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited. |
| Copyright |
Copyright © The Author(s), 2024. Published by Science Publishing Group |
Microbial Contamination, Non-sterile Pharmaceuticals, pH, Germination, Pharmaco-chemical, Good Manufacturing Practice
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APA Style
Ghulam Murtaza, Maqsood Ahmed Khan, Zeb-Un-Nisa, Sara Shafiq. (2021). A Review on the Microbial Contamination in the Non-sterile Pharmaceutical Products. Pharmaceutical Science and Technology, 5(2), 68-75. https://doi.org/10.11648/j.pst.20210502.17
ACS Style
Ghulam Murtaza; Maqsood Ahmed Khan; Zeb-Un-Nisa; Sara Shafiq. A Review on the Microbial Contamination in the Non-sterile Pharmaceutical Products. Pharm. Sci. Technol. 2021, 5(2), 68-75. doi: 10.11648/j.pst.20210502.17
AMA Style
Ghulam Murtaza, Maqsood Ahmed Khan, Zeb-Un-Nisa, Sara Shafiq. A Review on the Microbial Contamination in the Non-sterile Pharmaceutical Products. Pharm Sci Technol. 2021;5(2):68-75. doi: 10.11648/j.pst.20210502.17
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Download@article{10.11648/j.pst.20210502.17,
author = {Ghulam Murtaza and Maqsood Ahmed Khan and Zeb-Un-Nisa and Sara Shafiq},
title = {A Review on the Microbial Contamination in the Non-sterile Pharmaceutical Products},
journal = {Pharmaceutical Science and Technology},
volume = {5},
number = {2},
pages = {68-75},
doi = {10.11648/j.pst.20210502.17},
url = {https://doi.org/10.11648/j.pst.20210502.17},
eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.pst.20210502.17},
abstract = {This article aims to review available scientific data dealing with the Microbial contamination that may occur by some environmental factors (temperature, pH, and water activity), these factors are a major problem for the spoilage of pharmaceutical dosage form, and raw material, personnel, and other factor contributing to the transfer of the microbe into the pharmaceutical product. Non-sterile oral pharmaceuticals, including syrups, do not need to be sterile. At the same time, certain quality-control tests and some measures were followed, according to current good manufacture practice (cGMP), which are essential to keep the microbial content of these preparations safe and acceptable. Similarly, may manufacturer failures to comply with the Good Manufacturing Practice (GMP) at any stage of pharmaceutical production may consequently affect the microbiological quality of the product, and ultimately they caused economical loss for industrialists on the spoilage of pharmaceuticals. Microbial contamination in the pharmaceutical products increases from prescribed limits may change their Physico-chemical properties of the dosage form may be chances to hazardous for the immune-compromised patient due to overload microbial contamination. All the components of the non-sterile pharmaceuticals such as API and all kinds of excipients are at risk due to microbe overloaded and spoilage. Strictly the following (cGMP), continuous pharmaceutical surveillance is required to control microbial contamination within the pharmaceutical preparations.},
year = {2021}
}
TY - JOUR T1 - A Review on the Microbial Contamination in the Non-sterile Pharmaceutical Products AU - Ghulam Murtaza AU - Maqsood Ahmed Khan AU - Zeb-Un-Nisa AU - Sara Shafiq Y1 - 2021/12/11 PY - 2021 N1 - https://doi.org/10.11648/j.pst.20210502.17 DO - 10.11648/j.pst.20210502.17 T2 - Pharmaceutical Science and Technology JF - Pharmaceutical Science and Technology JO - Pharmaceutical Science and Technology SP - 68 EP - 75 PB - Science Publishing Group SN - 2640-4540 UR - https://doi.org/10.11648/j.pst.20210502.17 AB - This article aims to review available scientific data dealing with the Microbial contamination that may occur by some environmental factors (temperature, pH, and water activity), these factors are a major problem for the spoilage of pharmaceutical dosage form, and raw material, personnel, and other factor contributing to the transfer of the microbe into the pharmaceutical product. Non-sterile oral pharmaceuticals, including syrups, do not need to be sterile. At the same time, certain quality-control tests and some measures were followed, according to current good manufacture practice (cGMP), which are essential to keep the microbial content of these preparations safe and acceptable. Similarly, may manufacturer failures to comply with the Good Manufacturing Practice (GMP) at any stage of pharmaceutical production may consequently affect the microbiological quality of the product, and ultimately they caused economical loss for industrialists on the spoilage of pharmaceuticals. Microbial contamination in the pharmaceutical products increases from prescribed limits may change their Physico-chemical properties of the dosage form may be chances to hazardous for the immune-compromised patient due to overload microbial contamination. All the components of the non-sterile pharmaceuticals such as API and all kinds of excipients are at risk due to microbe overloaded and spoilage. Strictly the following (cGMP), continuous pharmaceutical surveillance is required to control microbial contamination within the pharmaceutical preparations. VL - 5 IS - 2 ER -
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