Cleaning Validation: An Important Aspect in Accessing Pharmaceutical Residues.
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The quality should be built in to the pharmaceutical product and the margin of errors should be none because it deals with the health. Pharmaceutical product can be contaminated either by previous drug manufacturing process in the industry, other exicipents, API, air borne contamination, dust, raw materials, etc. The cross contamination of the product can occur by the same or by other previous products. So proper cleaning should be ensured in order to avoid contamination. The interaction of pharmaceutical product with other substances may cause severe degree of damage to the quality, efficacy and safety of the product. Due to these reasons the cleaning of the equipment and various accessories should be done in order to prevent the contamination of the processing product and so the quality of the product can be retained. But cleaning alone cannot make things sure that there is no more interaction, so after cleaning the effectiveness of the cleaning can be measured by the validation. A cleaning validation provides documented evidence that the cleaning has been effectively performed and the chance of cross contamination and carryover of the previous products is negligible. By cleaning validation ensure the safety and purity of the product; it’s a regulatory requirement, and assures that quality is built into the product.
[1] Gil Bismuth,et al. Cleaning Validation: A Practical Approach , 2000 .