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PQRI Survey on the State of Implementation of ICH Q3D

Introduction

BACKGROUND

On November 9 - 10, 2020, PQRI will be hosting the 4th PQRI Workshop on ICH Q3D Elemental Impurities Requirements.  This workshop will provide an overview of the implementation and compliance experience since the 2017 PQRI Workshop and will review ongoing work throughout industry to resolve challenges involved in global implementation of the Elemental Impurities (EI) guidelines and standards. The results of the PQRI collaborative study concerning various analytical issues related to elemental impurity testing will also be reviewed along with a discussion on the impact these results may have on the basis of existing risk assessments.

Although the survey asks for your name and your company affiliation, the PQRI Secretariat will remove this information before sharing the anonymized aggregated results. Answers are confidential. Your responses will not be identified as coming from your company. The PQRI Secretariat is the only party who can link individual survey responses to responding companies and individuals, and can follow-up with respondents to clarify responses if needed. The PQRI Secretariat may also redact, anonymize, or aggregate responses to help protect the confidentiality of survey respondent’s identities.

Questions about the administration of or content of this survey may be directed to the PQRI Secretariat.


PURPOSE

The purpose of this survey is to survey possible Workshop attendees to understand the types of challenges they have experienced within their own organizations during the implementation of ICH Q3D.  The results of the survey will be blinded and aggregated and shared during the November 9-10, 2020 Workshop.  This information will be used to trigger further discussions on the key issues identified in the survey during the breakout sessions at the Workshop.

DEADLINE

Please complete the survey no later than Friday, October 2, 2020.
1. Please indicate if you are an ingredient/raw material supplier of if you are a drug product manufacturer.  You will then be directed to the appropriate survey. *This question is required.