A Study of Quality Control of Yemeni Pharmaceutical Industries Products
DOI:
https://doi.org/10.59846/ajbas.v3i2.728Keywords:
Keywords: Amoxicillin , Pharmaceutical Industries , Yemen .Abstract
The present study aimed to evaluate the drugs quality control of available in Yemen . The assessment of the quality of some Yemeni Pharmaceutical Industries products namely Paracetamol tablets 500 mg and Amoxicillin capsules 500 mg was based on United State Pharmacopoeia (USP) and European Pharmacopoeia (Ph. Eur.) The identification , dosage of active pharmaceutical ingredients and galenic tests of Paracetamol tablets and Amoxicillin capsules were performed . The results have shown high dosage of active component in some products which did not met the acceptance criteria in the USP (93%–107%) due to defects in the pharmaceutical production quality, and on the other hand the availability of good-quality another products. This could require setting up quality surveillance systems within drug regulatory authorities in the country, supporting manufacturers to improve Good Manufacturing Practice (GMP) compliance.
Keywords: Amoxicillin , Pharmaceutical Industries , Yemen .
References
LEVI, L., WALKER, G. C., & PUGSLEY, L. I. (1964). QUALITY CONTROL OF PHARMACEU-TICALS. Canadian Medical Association journal, 91(15), 781–785.
Sándor Görög , Drug safety, drug quality, drug anal-ysis. Journal of Pharmaceutical and Biomedical Analysis , 2008 , 48, (2) : 247-253.
Sarah K , Branch Guidelines from the International Conference on Harmonisation (ICH). Journal of Pharmaceutical and Biomedical Analysis . 2005 , 38(5) : 798-805 .
Barral E et al , The phenomenon of globalization in the pharmaceutical industry . Ann Pharm Fr. 1998 , 56(6):277-81
Ahmed Abdo-Rabbo, et al , The quality of antimalar-ials available in Yemen . Malaria Journal . 2005 , 4:28.
Unites State Pharmacopoeia . Unites States Pharma-copoeia Convention . 2009 , 32 .
European Pharmacopoeia . European Directorate for the Quality of Medicines - Council of Europe (COE). 2008 , 6.0 .
Amood Al Kamarany, M., Karbane , M. E., Alana-zi , F., Cherrah , Y., & Bouklouze , A. (2023). Effect of Biopharmaceutical Classification System on Pharma-cokinetic and Mechanism of Drug Release In vitro . Abhath Journal of Basic and Applied Sciences, 2(2), 49–53. https://doi.org/10.59846/ajbas.v2i2.524
Amood Al Kamarany, M., EL Karbane , M., Alanazi , F., Cherrah, Y., & Bouklouze, A. (2024). Transfer of Analytical Method’s Pharmacopoeias for Assay of Pharmacokinetic In-vitro and Impurities Profile Based on Different Concepts. Abhath Journal of Basic and Applied Sciences, 3(1), 18–23. https://doi.org/10.59846/ajbas.v3i1.637
Al-Kamarany, M. A., El Karbane, M., Ridouan, K., Alanazi, F. K., Hubert, P., Cherrah, Y., & Bouklouze, A. (2012). Transfer of drug dissolution testing by sta-tistical approaches: Case study. Saudi pharmaceuti-cal journal : SPJ : the official publication of the Sau-di Pharmaceutical Society, 20(1), 93–101. https://doi.org/10.1016/j.jsps.2011.08.006
Bonnes pratiques de fabrication . Agency Française de Sécurité Sanitaire de Produit de Santé Bulletin of-ficiel No. 2009 .
ICH. Good Manufacturing Practices (GMP) Guide for Active Pharmaceutical Ingredient . Q7A , 2002 .
The World Health Organization and The Government of The People’s Republic of China . International Conference of Drug Regulatory Authorities (ICDRA) . 24–27 June, 2002.
Amood Al Kamarany, M., & Abary , M. Y. S. (2023). In vitro – In vivo Correlation : Dissolution Profile and Pharmacokinetic of Calcium Carbonate Tablets Marketed in Yemen. Abhath Journal of Basic and Applied Sciences, 2(2), 54–60. https://doi.org/10.59846/ajbas.v2i2.525
Al-Kamarany MA, Alwosaby AS, El Karbane M, Karrouchi K. (2013) SFSTP guideline 1992- based vali-dation of direct potentiometric method for quan-tification of sodium bicarbonate in baby’s bliss gripe water available in Yemen. Int J Pharm Pharm Sci 5: 411-413.
Al-Kamarany, M. A., El Karbane, M., Belomaria, M., Azougagh, M., Hubert, P. H., Alanazi, F., & Bouklouze, A. (2012). Development and validation of LC method for the diclofenac sodium release de-termination using accuracy profile concept. Asian Journal of Chemistry, 24(10), 4393.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2024 Mohammed Amood Al Kamarany, Abdullah H Maad , Miloud El Karbane
This work is licensed under a Creative Commons Attribution 4.0 International License.