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 ...

1.0 OBJECTIVE : To establish a procedure to determine holding time limits of intermediate materials/products, equipments, chemicals/reagents. 2.0 SCOPE : This procedure is applicable for all products to be manufactured at (Company Name). 3.0 RESPONSIBILITY 3.1 Production/Engineering department shall ...