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Experiences of Lifecycle Changes - Site, Scale Up, Polymers and Suppliers

Leiner S.

Respiratory Drug Delivery 2016. Volume 1, 2016: 229-236.

Abstract:

Pharmaceutical lifecycle management of inhalation products is a complex task because of the large number of interacting critical quality attributes between the drug formulation and the inhaler, together with typically narrow operating windows for manufacture and control. Quality by design (QbD) has resulted in a more scientific and risk-based approach during the early stages of the product lifecycle, but these concepts should be extended across the entire lifecycle of the product, particularly in post-approval change management. Opportunities to prospectively manage future changes where there is enhanced product knowledge and process understanding are lacking. This article exemplifies lifecycle changes of inhalation products related to changes in manufacturing site, scale up, polymers, and supply chains, and discusses regulatory, logistical, and scientific strategies to facilitate the management of post-approval changes in a more predictable and efficient manner across the product lifecycle. Permanent product maintenance may offer a solution to shorten the duration of pharmaceutical lifecycle management of inhalation products while maintaining the bridge to the pivotal in vivo data.