By Kenneth Norris
“We know so much about the manufacturing process, our product, and its stability that when it’s properly packaged and stored, we can guarantee that the product will be within specification at the end of shelf-life and testing to prove it is not justified.” Quite a bold statement! While industry is not confident enough to make this type of statement today (even to most internal audiences), industry is moving in this direction (and away from the practice of over testing “just to be sure”) and a lean stability philosophy is the vehicle to move this forward.
A lean stability strategy is science- and risk-based, providing focus on meaningful attributes and time points. A lean strategy could include technical adjustments to stability protocols or strategies to improve efficiency and expedite results without impacting safety, efficacy, or quality of the product. It does not reduce knowledge or put the patient at risk. Lean stability strategies could result in less frequent and/or delayed pull points, fewer stability conditions, and streamlined analytical test profiles that focus on the individual product’s stability-related quality attributes (SRQAs) and ideally include only the shelf-life limiting attributes (SLLAs). Lean strategies can facilitate the development and approval of new and improved medicines by emphasizing the key elements that contribute to quality, safety, and efficacy while deemphasizing elements that do not.
Although lean stability is not specifically mentioned in regulatory guidance, International Conference on Harmonisation (ICH), World Health Organization, and other guidances do permit alternative approaches if adequately justified. Lean stability strategies do not represent any deviation from what is currently allowed and represent an evolution of thinking, not a revolution.
The cover article in the September issue of the AAPS Newsmagazine overviews several aspects of lean stability, including statistical considerations, stability modeling, and lean strategies in practice. Read Lean Stability, from the APQ section, and then participate in the discussion point below.
What challenges do you see related to the use of lean stability strategies in regulatory filings, and how would you address them?