IGDRP Offers Guidance for Quality Assessors on Drug Substances
The International Generic Drug Regulators Programme (IGDRP) on Tuesday released guidance finalized in June to help regulatory agencies’ quality assessors review technical information on active substances.
Initially drafted by regulators from Australia, Canada, Singapore and Switzerland, the document provides assistance to quality assessors in reviewing the technical information contained in the Quality Module (Module 3) of Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) and marketing authorisation applications (MAAs).
"In line with IGDRP’s broader objectives, the IGDRP believes that the publishing of this guidance may also be of benefit to national regulatory agencies who are not members of IGDRP, and to parties responsible for the preparation of quality information that is submitted to regulatory agencies," IGDRP said.
In the section on notes on preparing a Quality Assessment Report (QAR), the guidance points to 14 aspects that should be considered in conducting the technical assessment of the Quality Module and in the generation of the QAR, including summaries of the critical assessments by the assessor of the data provided in the ASMF/DMF or application (as applicable) and scientific discussions reflecting the assessor’s views on the information and salient findings.
The guidance also features what information should be stated in the QAR with respect to general information, manufacturing, characterization, control of the drug substance, reference standards or materials, container closure system and stability.
In addition to the guidance, next year, IGDRP and the International Pharmaceutical Regulators Forum plan to join forces.