Hold Time Study

Holdtime can be considered as the established time period for which materials (dispensed raw materials, intermediates and bulk dosage form awaiting final packaging) may be held under specified conditions and will remain within the defined specifications. 21 CFR 211.111 Time Limitations on Production states: When appropriate, time limits for the completion of each phase of…

A Hold Time Study Protocol is a document that outlines the procedures and criteria for conducting a hold time study in a pharmaceutical industry. 1. Objective \ Scope 1.1. Hold time study data shall give the assurance of the maximum allowable hold times for bulk and in-process drug products. Generally, one lot can be used…