Blogs

Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.  In part 2 of this blog series, some of the key takeaways will be discussed in more detail.  Q12 is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.

ICH (International Council for Harmonization) recently adopted (1 Nov 2019) the guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.

On March 26, the Delaware Valley Chapter of PDA and West Pharmaceutical Services, Inc. co-sponsored a workshop: Defining a Strategy for Combination Products, at West’s headquarters in Exton, PA. More than 150 people from 45 companies that provide drug products and combination products attended. In prior PDA events, combination product regulatory challenges have been cited often as an area both of interest and confusion. This workshop aimed to address them.

There are many benefits associated with the use of combination products (e.g., SmartDose® and SelfDose® Drug Delivery Platforms). Since combination products are often patient centered, they are designed to be convenient, assist in maintaining a drug therapy from home, and help to enable better compliance. To ensure these benefits, developers must formulate and execute a proper design verification study to minimize impacts by unknown risks.

Knowledge generation and risk reduction are goals of combination product testing. A risk-based, and standards-based, testing strategy creates not only a quality product, but ensures continuity between past and future data sets. This enables the long-term, safe, and efficient delivery of drug products to patients. And time to market is improved by reducing product launch false starts.