Addendum – Quality (chemistry and manufacturing) Guidance: Questions and Answers

From Health Canada

Overview

The purpose of the guidance document is to outline the Quality technical requirements and to assist submission sponsors in preparing the New Drug Submission or Abbreviated New Drug Submission to ensure an effective and efficient assessment process. It can also be used as guidance on the requirements for related drug submissions [for example (e.g.), Supplemental New Drug Submissions (SNDSs), Supplemental Abbreviated New Drug Submissions (SANDSs), Post-Notice of Compliance (NOC) Changes].