Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products; Establishment of a Public Docket; Request for Comments

The Parenteral Drug Association (PDA) is submitting the attached responses on behalf of a group of our members regarding FDA's discussion paper on Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products. The paper provided the industry with FDA perspectives on this issue and PDA's members have collaborated to collectively reply to the questions posed by the agency. In the attached comments, the team offers insight and suggestions that may assist the agency in formalizing and finalizing guidance related to NDSRIs. PDA is a non-profit international professional association of more than 10,000 individual member scientists having an interest in the fields of pharmaceutical, biological, and device manufacturing and quality. These comments have been prepared by a group of volunteers with expertise in pharmaceutical and biopharmaceutical manufacturing with the aim of aligning on best practices and policies to ensure patient safety and continuity of drug supply.