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The paper provides two solutions that lay the foundation for an aligned and standardized industry position on the topic of effective management of post-approval changes in the Pharmaceutical Quality System (PQS). This document represents the 1VQ standard approach for the steps necessary to establish and demonstrate an effective quality system to fully leverage a risk-based approach to post-approval changes as laid out by ICH Q10 Annex 1. Implementation of the solutions presented in this paper can help achieve a transformational shift with
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