Temperature excursion management: A novel approach of quality system in pharmaceutical industry.
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.
Sikkim Manipal Institute of Technology (A Manipal Group College), Majitar, Rangpo, Sikkim 737136, India.
Nirmal
N
Kumar
Sikkim Manipal Institute of Technology (A Manipal Group College), Majitar, Rangpo, Sikkim 737136, India.
Ajeya
A
Jha
Degradation products; Formulation; GMP; Quality by Design; Temperature excursions management