Annex 20 is a voluntary annex; however, the principles outlined in the annex are applicable to the manufacture of therapeutic sunscreens.
Annex 20 corresponds to ICH Q9 guideline on quality risk management. It provides guidance on a systematic approach to quality risk management facilitating compliance with GMP and other quality requirements. It includes principles to be used and options for processes, methods and tools which may be used when applying a formal quality risk management approach.
Chapter 1 (Quality Management of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, PE009-13), has been revised to include aspects of quality risk management within the quality system framework.
