Quality of pharmaceutical product largely depends upon by 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 an d 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.
GMP; Temperature excursions management; Formulation; Quality by Design; Degradation products
Citation: Kumar, N., Jha, A., Temperature excursion management – A novel approach of quality system in pharmaceutical industry, Saudi Pharmaceutical Journal(2016),doi: http://dx.doi.org/10.1016/j.jsps.2016.07.001
Received: 12 December 2015, Accepted: 1 July 2016, Available online: 9 July 2016
Copyright: © 2016 Production and hosting by Elsevier B.V. on behalf of King Saud University.Open Access funded by King Saud University
Temperature excursion is a general term that represents the environmental excursions. However, there is a need of holistic approach to handle the temperature excursions starting from raw material manufacturing site to medicine retailers shop to protect quality of product. The temperature excursion at any stage of pharmaceutical business operation must be reported as soon as possible and investigated appropriately. The consequences of deviation against temperature and humidity limits should be studied appropriately by quality assurance personnel. The risk of temperature excursions cannot be ruled out, but it can be minimized through effective system. Alternative is to use thermal resistant packaging and stringent control measures during transit and shipment, to avert the undesired quality impact on pharmaceutical product. The systematic approach to handle the issues related temperature excursions become inevitable for pharmaceutical manufacture.