Hold Time studies establish the time limits for holding the materials at different stages of production to ensure that the quality of the product does not degrade significantly during the hold time at a required temperature and Relative Humidity. When appropriate, time limits for the completion of each ...

In the realm of pharmaceutical manufacturing, ensuring product quality, efficacy, and safety is paramount. One crucial aspect contributing to these factors is the concept of hold time studies. Hold time refers to the duration that materials, intermediates, or products are kept in a controlled environment ...

Manufacturers should ensure that the products are safe, effective and of the quality required for their intended use. Systems should be in place to ensure that pharmaceutical products are produced according to validated processes and to defined procedures. Manufacturing processes should be shown to ...

BARBARA PIROLA: Hold time 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 What tools do pharmaceutical ...

Upon receipt of Hold Time (HT) samples along with the test request form, the person receiving the samples shall take the samples to QC Documents room for making entry in the respective logbooks (Annexure). After the entry in the logbook, the AR No. shall be mentioned on the label of the sample packs ...