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As per available reports about 36 Relevant Journals, 40 Conferences are presently dedicated exclusively Product stability testing and about 203 Articles are being published on Product stability testing.
The purpose of stability testing is to provide evidence on how the quality of an active substance or pharmaceutical product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. In addition, product-related factors influence the stability, e.g. the chemical and physical properties of the active substance and the pharmaceutical excipients, the dosage form and its composition, the manufacturing process, the nature of the container-closure system, and the properties of the packaging materials. Also, the stability of excipients that may contain or form reactive degradation products, have to be considered. As a result of stability testing a re-test period for the active substance or a shelf life for the pharmaceutical product can be established, and storage conditions can be recommended. And includes Quality Assurance, Validation, Contract & Sterile/Aseptic Manufacturing ,Storage, Distribution, Transportation
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Scope and Importance:
Information on the stability of the active substance is an integral part of the systematic approach to stability evaluation. For active substances not described in an official pharmacopoeia monograph, stability studies are required. For active substances described in an official pharmacopoeia monograph, which covers the degradation products and for which suitable limits have been set but a re-test period is not defined, two options are acceptable.
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. The choice of test conditions defined is based on an analysis of the effects of climatic conditions in the three regions of the EC, Japan and the United States. The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV. The principle has been established that stability information generated in any one of the three regions of the EC, Japan and the United States would be mutually accept able to the other two regions, provided the information is consistent and the labeling is in accord with national/regional requirements.
Market Analysis:
The market research available can provide investors and analyst credible information on the direction of pharmaceuticals and pharmaceutical industry is one of the largest and most advanced among the developing countries and it is 3rd largest pharmaceuticals market by 2020 and the pharmaceuticals industry accounts for about 2.4% of the global Pharma industry by value and 10% by volume.
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This page was last updated on December 24, 2024
