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PDA PAC-2021

2021 Post-Approval Change Issues and Impacts Survey

Every pharmaceutical and biopharmaceutical product undergoes manufacturing changes after its initial approval by regulatory authorities. PDA sought the input of experts about the most significant post-approval change issues faced by manufacturers of drug products and/or active pharmaceutical ingredients (APIs). By understanding the challenges that industry faces in making changes to products after the initial regulatory approval, regulators and industry together can develop effective solutions and prioritize the issues with greatest impact on global operations.   The survey was targeted at individuals who work for a company that manufactures finished products for human use (whether small molecule, advanced therapy, biologic, vaccine, or other) or APIs, and who have insights into both the types of post-approval changes that affect manufacturing and the impact those changes have on manufacturing operations.   This survey is a follow-on to 2016 PDA survey, the results of which were published in the PDA Journal. (1) This document includes certain results from that earlier survey that help illuminate or expand the discussion.

Parenteral Drug Association [pda]

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