By Kenneth Norris
The primary reason for stability testing is to ensure the safety of the patient through establishing the expiration dating period of the pharmaceutical product. Understanding the stability of an active pharmaceutical ingredient (API) or drug formulation is one of the most important factors in determination of the viability of a drug product. Stability testing evaluates the effect of environmental factors on the quality of the API and drug product, which is utilized to predict shelf life, determine storage conditions, and suggest labeling instructions. Also, data generated from stability testing is a requirement for regulatory approval of a product. Because stability testing can involve considerable cost, is time consuming, and is important in regulatory filings, it is imperative that it is done correctly.
In response to the need for training in this field, the AAPS APQ section and the Stability focus group have developed an eCourse, Stability Testing of Pharmaceutical Products, for professionals looking to brush up on their skills and expand their stability testing knowledge. Upon completion of this course, participants will be able to:
- understand the current regulations globally required for stability program to support expiration dating and use periods of drug products/API,
- understand requirements for stability indicating methods,
- monitor impurities in API and drug products,
- set stability specifications and change controls,
- evaluate stability data, and
- establish a stability report and chemistry, manufacturing, and controls documents
For those of you attending the AAPS Annual Meeting and Exposition, the organizing team will be presenting a unique and exclusive look into this course’s curriculum. Join us on Monday, October 26 in Orlando from 2–4 pm ET (room W304CD) to hear the speakers discuss Essentials of Stability Testing for Pharmaceutical Scientists: A Live Session of Stability Testing 101 eLearning Course. Add this to your schedule on the AAPS Web app now!
I would like to acknowledge the organizing team members, who have been instrumental in the design of the curriculum and oversight of the process including myself, Kim Huynh-Ba (cochair), Anita Freed, Mark Alasandro, Karen Lucas, Yan Wu, and Nanda Subbarao.