Hold Time Study Protocol
<p><strong>1.1.</strong> 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.</p>
<p><strong>1.2.</strong> 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.</p>
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