IGDRP Publishes Guidance for Quality Assessment Reports of Active Substances

The International Generic Drug Regulators Programme released guidance for quality assessors in regulatory agencies on the preparation of quality assessment reports, and noted the guidance may be useful for anyone responsible for the preparation of quality information submitted to regulatory agencies.

Among other details, QARs should include information about the substance’s process validation, including a summary of the validation or evaluation studies used in aseptic processing or sterilization, as well as justifications for the choice of sterilization methods.

Assessors should also include information about the drug substances’ general properties and physical characteristics, plus solubility in solvents involved in manufacturing or cleaning processes.