QA/QC in Pharmaceutical Industry: Role of Analytical Techniques
Journal Title: Biomedical Journal of Scientific & Technical Research (BJSTR) - Year 2017, Vol 1, Issue 1
Abstract
This brief review presents the international approaches to assessment of the content of geotaxis impurities (residual solvents and various inorganic and organic impurities) in pharmaceuticals. Nowadays, it has become necessary to provide not only purity profile but also impurity profile of a particular pharmaceutical product because of national and international regulations. These aspects along with significance of the quality, efficacy and safety of pharmaceuticals, including the source of impurities, kinds of impurities, control of impurities and regulatory aspects are discussed. The supply of essential medicines of good quality has been identified as one of the prerequisites for the delivery of health care system of any country as poor quality medicines can harm or even kill consumers. The presence of unwanted chemicals in a particular medicine, even in extremely small quantities, may influence its efficacy and safety. Unlike in other industries, a medicine is a dynamic product whose color, consistency, weight, and even chemical identity can change between manufacture and ultimate consumption. Hence, quality of pharmaceuticals has been a concern of the people of the whole world, and is now receiving critical attention from regulatory authorities [1]. Impurities in pharmaceutical products are of great concern not only due to the inherent toxicity of certain contaminants, but also due to the adverse effect that contaminants may have on drug stability and shelf-life. In pharmaceutical and drug products, impurities are the unwanted chemicals (organic, inorganic and residual solvents) that remain with the active pharmaceutical ingredients (APIs), or develop/added during formulation, or upon aging. Organic impurities are the most common impurities found in every API which get incorporated normally during the multi-step synthesis process despite proper care [2,3]. Some of the metals such as lead, arsenic and platinum even at low concentrations are toxic and harmful to humans [4]. The presence of these organic and metallic impurities even in small amounts may influence the efficacy and safety of the pharmaceutical products. Therefore, impurity levels need to be controlled such that pharmaceutical products are sufficiently safe to be administered to humans. The recent changes in the European Pharmacopoeia (EP), the United States Pharmacopoeia (USP) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) regulations for inorganic impurities and new strategies require companies to adopt new strategies for heavy metal analyses. The European medicines agency (EMA) has set guidelines for the limits of residual metal elements. The U.S. Food and Drug Administration (FDA) and the British Pharmacopeia (BP) and other regulating bodies such as the Japanese Pharmacopoeia (JP) and the Indian Pharmacopoeia (IP), strongly advise that contamination problems should be fully investigated in a timely fashion. The existing ICH Q3A Guideline classifies impurities as organic, inorganic, and residual solvents [5]. The Q3A and Q3B Guidelines effectively address the requirements for organic impurities, while Q3C covers requirements for residual solvents.
Authors and Affiliations
Balaram V
Keywords
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- EP ID EP566634
- DOI 10.26717/BJSTR.2017.01.000109
- Views 172
- Downloads 0
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