Kumar Nirmal, Jha Ajeya
Sikkim Manipal Institute of Technology (A Manipal Group College), Majitar, Rangpo, Sikkim 737136, India.
Saudi Pharm J. 2017 Feb;25(2):176-183. doi: 10.1016/j.jsps.2016.07.001. Epub 2016 Jul 9.
Quality of pharmaceutical product largely depends upon the environment controls during its storage and handling. Each pharmaceutical product should be handled and stored under specified storage condition labelled on product information data sheet or product pack. Hence the temperature excursions during receipt of raw materials, manufacturing of pharmaceutical products and distribution should be managed during entire product life cycle with holistic approach. The research is based on primary data and exploratory study through literature review. The temperature excursion may be observed during transportation of raw materials manufacturing as well as distribution of pharmaceutical products, which have potential to deteriorate the product quality. Temperature excursion in pharmaceutical industry should be recorded and reported to the manufacturer for further investigation and risk analysis. The concept of temperature excursions, its reasons, consequences and handling mechanism should be well understood to ensure the concerted efforts under the aegis of Quality Management System. Based on the reasons and consequences of temperature excursions during pharmaceutical operations, a system based quality management has been envisaged through this study. The concept and procedure to handle temperature excursion have evolved after this study which shall be useful to pharmaceutical industry as well as to medicine distributors and consumers.
药品质量在很大程度上取决于其储存和处理过程中的环境控制。每种药品都应在产品信息数据表或产品包装上标明的特定储存条件下进行处理和储存。因此，在整个产品生命周期中，应采用整体方法来管理原材料接收、药品生产和分销过程中的温度偏差。本研究基于通过文献综述获得的原始数据和探索性研究。在原材料制造以及药品分销的运输过程中可能会观察到温度偏差，这有可能降低产品质量。制药行业的温度偏差应记录并报告给制造商，以便进行进一步调查和风险分析。应充分理解温度偏差的概念、其原因、后果和处理机制，以确保在质量管理体系的支持下共同努力。基于制药操作过程中温度偏差的原因和后果，本研究设想了一种基于系统的质量管理方法。本研究之后，处理温度偏差的概念和程序得到了发展，这将对制药行业以及药品经销商和消费者有用。
