International Journal of Pharmaceutical and Life Sciences https://ijlsbd.com/index.php/01 <p>International Journal of Pharmaceutical and Life Sciences (IJPLS) is an international, open access, peer-reviewed e-journal. IJPLS will be published monthly. IJPLS will publish original research papers, review articles, and conceptual articles on pharmaceutical and life sciences.</p> <p>IJPLS will publish original research papers, review articles, and conceptual articles on the following area of Pharmaceutical Sciences-</p> <p>Pharmacognosy, Pharmacology, Pharmaceutical Technology, Pharmaceutics, Pharmaceutical Analysis, Pharmaceutical Chemistry, Pharmaceutical Biotechnology, Quality Assurance of Pharmaceuticals, Regulatory/Industrial Affairs of Pharmaceuticals.</p> <p>IJPLS will publish original research papers, review articles, and conceptual articles on the following area of Life Sciences-</p> <p>Biology, Microbiology, Biochemistry, Biotechnology, Public Health, Toxicology, and other life sciences topics.</p> <p> </p> en-US editor@ijlsbd.com (Kazi Fahmida Nur) jihanchowdhury70@gmail.com (Jihan Chowdhury) Mon, 31 Oct 2022 15:00:52 +0000 OJS 3.3.0.8 http://blogs.law.harvard.edu/tech/rss 60 Nitrosamine Impurities: Sources and Control https://ijlsbd.com/index.php/01/article/view/63 <p>In June 2018, FDA was informed of the presence of an impurity identified as N-nitrosodimethylamine (NDMA) in the angiotensin II receptor blockers (ARB) valsartan. Through investigation, the Agency determined that numerous lots of valsartan and a few other ARB drug products from different manufacturers contained unacceptable levels of nitrosamines. The drug product manufacturers voluntarily recalled the affected batches of these drug products.</p> <p>In September 2019, FDA learned that some common heartburn products (ranitidine, commonly known as Zantac, and nizatidine, commonly known as Axid) contained unacceptable levels of NDMA. FDA recommended that manufacturers voluntarily recall ranitidine and nizatidine products with NDMA levels above what the Agency considers acceptable. FDA’s testing suggests that NDMA levels increase with storage time. On April 1, 2020, FDA requested that all ranitidine products be withdrawn from the U.S. market.</p> <p>In May 2020, FDA testing revealed that certain lots of metformin extended-release formulation contained NDMA above the Agency’s recommended acceptable intake limit. Based on that testing, FDA requested that identified applicants voluntarily recall these lots of the extended-release metformin.</p> <p>FDA and other regulatory authorities have partnered to share information and to develop guidelines to mitigate the risk of nitrosamine impurities in drug products.</p> <p>In this article, sources of nitrosamine and mitigation measures are discussed based on regulatory guidelines.</p> Fariha Sultana Copyright (c) 2022 International Journal of Pharmaceutical and Life Sciences https://ijlsbd.com/index.php/01/article/view/63 Mon, 31 Oct 2022 00:00:00 +0000 Impact of USP on the Regulatory Approval of the Drug https://ijlsbd.com/index.php/01/article/view/61 <p>The purpose of this article is to introduce the reader to the United States Pharmacopeia/National Formulary (USP/NF) and to its formal and legal role in the Food and Drug Administration's (FDA) drug regulatory process in the United States<sup>1</sup>. It is important to notice the concurrent development of key events in the history of U.S. food and drug law with the development of the USP and NF, two drug standards compendia that originated from different parts of the health care delivery system<sup>2,3</sup>. Since their founding in 1820 and 1888, respectively, the United States Pharmacopeia (USP) and the National Formulary (NF) have worked to create public standards for the purity, quality, and strength of medical products, as well as compounding information. In addition to its other regulatory responsibilities, the Food and Drug Administration (FDA), which was formally established in 1938, has always been involved in enforcing purity and potency standards for drug materials, a role that dates back to the Bureau of Chemistry of the Department of Agriculture in 18622,<sup>3</sup>. Public standards for the strength and purity of medications have been enforced by the federal government since at least 1848, when the USP, a private, nongovernmental organization, first interacted with the government on the matter. To stop the entry of spurious or substandard medications into the country, Congress created the Drug Importation Act in 1848. Drugs that do not meet the "standard established in the United States Pharmacopoeia, and therefore improper, unsafe, or dangerous to be used for medicinal purposes, the articles shall not pass the custom house" are not allowed to enter the United States<sup>4</sup>.</p> Arjun Pande, Rudra Chowdhury Copyright (c) 2022 International Journal of Pharmaceutical and Life Sciences https://ijlsbd.com/index.php/01/article/view/61 Mon, 31 Oct 2022 00:00:00 +0000 Microbial Control of Pharmaceutical Raw Materials https://ijlsbd.com/index.php/01/article/view/62 <p>Microbial contamination control of pharmaceutical products is a great challenge. In this article, different sources of microbial contamination have been identified including microbial contamination of pharmaceutical products due to contamination from raw materials. This microbial contamination can significantly impact patient’s health and thus trigger recall of products. In this article, prevention of microbial contamination from raw materials are mentioned which could ensure safety of patient’s health as well as prevent recall of products.</p> Kapil Sharma, Sonya Mulkeet Copyright (c) 2022 International Journal of Pharmaceutical and Life Sciences https://ijlsbd.com/index.php/01/article/view/62 Mon, 31 Oct 2022 00:00:00 +0000 HVAC for non-sterile Pharmaceutical Products: Design, Qualification and Maintenance https://ijlsbd.com/index.php/01/article/view/60 <p>Heating, ventilation and air-conditioning (HVAC) system plays an important role to ensure the manufacture of quality pharmaceutical products. In this article, design consideration, qualification requirements and maintenance of HVAC has been discussed. Regulatory guidelines and risk-based approaches are considered. Pharmaceutical company should design HVAC, qualify and managed the HVAC system based on risk assessment.</p> Tareq Rahman, Amalesh Singh Pawar Copyright (c) 2022 International Journal of Pharmaceutical and Life Sciences https://ijlsbd.com/index.php/01/article/view/60 Mon, 31 Oct 2022 00:00:00 +0000