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Abstract

CLEANING VALIDATION OF PHARMACEUTICAL DOSAGE FORMS

Gupta Mamta* and Bharkatiya Meenakshi

ABSTRACT

Cleaning validation is the process of providing documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels. Residue identification in a pharmaceutical manufacturing environment involves cleaner, primary ingredients, excipients, decomposition products and preservatives. The main purpose of cleaning validation is to prove the effectiveness and consistency of cleaning in a given pharmaceutical production equipment to prevent cross contamination and adulteration of drug products with other active ingredients like unintended compounds or microbiological contamination, leading to prevent several serious problems. The basic mechanisms involved in removing the residues and contaminants from the equipment are mechanical action, dissolution, detergency and chemical reaction. Residual materials from the previous batch of the same product or from different product may be carried to the next batch of the product, which in-turn may alter the impurity profile of the subjected product. Selection of appropriate sampling to demonstrate that residues have been removed to an acceptable level is vital for the success of cleaning validation.

Keywords: Contamination, cleaning validation, residue.


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