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Abstract

Cleaning Validation Of Liquid Orals

Author(s): R Dang, K. L. K Paranjothy, Shobha Rani, R Hiremath

The manufacture of pharmaceutical products, active ingredients and medical devices has only one aim, safe products that consistently meet high Quality Standards. Validation provides documented evidence that processes are under control and that consistent product quality is assured. The overall objective of any cleaning validation is to assure that Intermediates, excipients, cleaning agents and most importantly active drug ingredients from the previous production batch do not contaminate the product. Taking the example of two liquid oral preparations, it was developed and proved that three consecutive washes with demineralised water (DM) were better than any soap/chemical washes to prevent cross-contamination in subsequent batches.

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