Industry One-Voice-Of-Quality (1VQ) Solutions Management Review (MR) of Post Approval Changes (PAC) Guide

Anders Vinther; Fanzia Mohammed; Emma Ramnarine

doi:10.5731/pdajpst.2021.012627

Abstract

Post-approval changes (PACs) are inevitable and necessary throughout the life of a drug product. Because many PACs require prior approval by individual regulatory agencies each having their own reporting requirements and approval timelines this results in companies having to manage several versions of a manufacturing process at the same time. The global regulatory complexity increases risk of drug shortages. Chief Quality Officers and Heads of Quality from more than 20 global pharmaceutical companies have come together to speak with One-Voice-Of-Quality (1VQ) and develop solutions to this problem by developing a science and risk-based approach to manage more PACs in the PQS rather than submitting these as prior approval supplements. The paper ″Industry One-Voice-of-Quality (1VQ) Solutions. Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches″ (PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 456-467; DOI: https://doi.org/10.5731/pdajpst.2020.011734) outlines such solutions. Pharmaceutical companies already conduct Management Review (MR) according to ICH Q10. This One-Voice-Of-Quality (1VQ) paper is a practical guide on how companies can expand the MR to also evaluate and demonstrate the effectiveness of their Pharmaceutical Quality System (PQS) in specifically managing PACs to achieve regulatory flexibility as stated in ICH Q10, Annex 1. Examples of PQS Key Performance Indicators (KPIs) that may be used to assess, plan, implement, and monitor PACs are described. The intent is to provide assurance through MR that PACs can be managed effectively in the PQS, thereby resulting in a reduced need for regulatory prior approval of certain low risk changes that enhance product availability, reduce the risk of drug shortages, and/or facilitate timely innovation and continual improvement in the pharmaceutical industry. This document is endorsed by 1VQ Chief Quality Officers and Heads of Quality.

Received January 18, 2021.
Accepted March 3, 2021.

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