Hold time study for pharmaceutical binders, lubricated granules, compressed tablets, coating suspension and coated tablets during manufacturing process

Although there are no specific regulations of guidance document on bulk product holding times, good manufacturing practice dictates that holding should be validated to ensure that in process and bulk product can be held, pending the next processing step, without any adverse effect to the quality of the material. The time period for which the product is on hold shall be justified with adequate data to demonstrate the product will be stable throughout the approved shelf life. The time during which the product is stored in the bulk container, prior to packing into the final immediate container, constitutes part of the approved shelf life, i.e., the date of expiry remains a function of the date of manufacture, not the date of packing. The conclusions from this article may lead to guidelines on sampling, storage and holding times for Pharmaceutical Tablet and during manufacturing process. Most appropriate storage and preservation protocol should be based on the specific study objectives and focus.

Author(s): Deepak. P. Pawar, Prashant. B. Shamkuwar and Avinash. H. Hosmani

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