TRS 992 - Annex 4: General guidance on hold-time studies

Overview

These guidelines focus primarily on aspects that should be considered in the design of the hold-time studies during the manufacture of non-sterile solid dosage forms. Many of the principles described here also apply to other dosage forms such as liquids, creams and ointments. These guidelines do not cover aspects for hold times in cleaning validation, or the manufacturing of active pharmaceutical ingredients (APIs) or biologicals.