Introduction: Manufacture should ensure that the products they are manufacture are safe, effective and quality required for intended use. System should be in-place and in-use to ensure that the products manufactured as per validated process. As per Good manufacturing practices, manufacture should ensure that the dispensing raw materials and packing materials, intermediates products, bulk and finished product are stored under suitable conditions. Storage arrangement should be such which safeguard the subsequent processing, stability, safety, efficacy or quality of starting materials, intermediate products, and bulk drug prior to final packing. Maximum hold time should be established to ensure that intermediate and bulk product can be held without producing results outside the acceptance criteria for the quality of the material. Intermediate and bulk product should not be store beyond the established hold time. The choice of maximum hold time should be supported by relevant data. man...
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