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 for validating hold times if any inconsistency results were observed then another two lots can be used for this study.
1.2. Although there are no specific regulations or guidance documents on bulk product hold times, GMP dictates that hold times should be validated to ensure that in-process and bulk products can be held, pending the next processing step, without any adverse effect on the quality of the material. Hold time study provides the re-assurance of the quality at each in-process stage.