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Showing posts from September, 2021

Introduction of Cleaning validation

Introduction           The primary benefit usually attributed to a cleaning validation  is ensuring compliance with federal regulation. However, a more important benefit from conducting cleaning validation work is the identification and correction of potential problem, previously unsuspected, which could compression the safety, efficacy, or quality of subsequent batches of the drug product produced with the equipment.      Several serious problem can be prevented through the use of the reasonable cleaning validation program. All are related to adulteration, therapeutic safety and efficacy, or overall quality of the product over its shelf life. Cross contamination with active ingredients :   Contamination of one batch of product with significant level of residual active ingredients from a previous batch cannot be tolerated.  Contamination with unintended material or components :  Excipients used in drug products are genera...