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Abstract

Global regulatory guidance for post approval changes to chemisty manufacturing controls (CMC) of commercial drug products lack harmonisation. Implementation of post-approval changes are slow and complex which can lead to supply issues of medicinal products with little or no continuous improvements to manufacturing processes being made. ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management was published in November 2019. This guideline provides a framework to facilitate the management of post-approval CMC changes in a more predictable and efficient manner. Tools and enablers in the guidline aim to enhance the transparency between the industry and the regulatory authorities while promoting innovation and continual improvement. This research paper explores the advantages of implementing ICH Q12 through a literature review, 2 industry based case studies that demonstrate the use of the regulatory tools which are described in the guideline and subject matter experts (SMEs) were interviewed for their opinions on post approval change management.

DOI

https://doi.org/10.21427/raht-ra60

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Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-Share Alike 4.0 License.

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