Regulatory Requirements and Innovation: A Comparison of Stability Study in the United States Food and Drug Administration (USFDA) and the Gulf Cooperation Council (GCC)

  • Reshma Pushpa Murali Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, INDIA
  • Lovely Joylein Castelino Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, INDIA
  • Ravi Gundadka Shriram Research and Development Department, Neopharma LLC, Industrial City of Abu Dhabi (ICAD), Mussafah, Abhu Dhabi, UAE
  • Akhilesh Dubey Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka, INDIA
Keywords: Stability study, USFDA, GCC, ICH, WHO

Abstract

Stability studies form a crucial aspect of the pharmaceutical development process and play a vital role in establishing the quality, safety and efficacy of the drug product. The core objective of a stability study is to ascertain the shelf-life of a drug product and to understand how best to design the drug product and its container-closure system so as to ensure that the same maintain suitable physical and chemical properties during the proposed shelf-life period. Since stability studies are inherently crucial to the lifecycle of a pharmaceutical formulation, the process and its requirements are subject to stringent regulations and specifications by regulatory authorities around the globe. A multitude of guidelines have been published in this regard by various regulatory authorities entailing concepts, techniques and protocols associated with stability testing, with the aim of aiding drug manufacturers generate accurate and viable stability data. Most of these guidelines, however, are based on the International Council for Harmonisation (ICH) stability guidelines and have been adapted by individual regulatory authorities to complement the climatic conditions of the respective regions, two such examples being the United States Food and Drug Administration (USFDA) and the Gulf Cooperation Council (GCC). Therefore, the present work aims to briefly discuss the stability guidelines applicable in each region and identify any similarities and differences, whilst examining the documentation requirements related to stability studies as well as the dossier requisites to be adhered to during drug product registrations.

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Regulatory Requirements and Innovation: A Comparison of Stability Study in the United States Food and Drug Administration (USFDA) and the Gulf Cooperation Council (GCC)
Published
2020-10-02
How to Cite
1.
Murali R, Castelino L, Shriram R, Dubey A. Regulatory Requirements and Innovation: A Comparison of Stability Study in the United States Food and Drug Administration (USFDA) and the Gulf Cooperation Council (GCC). ijpi [Internet]. 2Oct.2020 [cited 27Oct.2020];10(3):263-7. Available from: http://www.jpionline.org/index.php/ijpi/article/view/765