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A Review On Scope And Applications Of Cleaning Validation In The Pharmaceutical Industry
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| Author:
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I.PONNILAVARASAN, S.VIGNESH, M.VELMURUGAN, D.GOWTHAM, M.PRAKASH
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| Abstract:
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In the pharmaceutical industry, there is some potential for contamination and cross-contamination because of improper cleaning of equipment, apparatus, processing area, or the starting material, this can lead to harmful hazards, therefore in the pharmaceutical industry we can't afford any contamination as well as cross-contamination. This can be reduced by proper cleaning of equipment, apparatus as well as the processing area. The Industry wants to achieve these main goals with the help of GMP. Pharmaceutical Manufacturers should validate their cleaning process to assure complies with cGMP guidelines. Reducing equipment downtime can maybe affect the productivity and financial aspects of pharmaceutical production. The important role of cleaning validation is to prove the effectiveness and consistency of cleaning in a piece of given pharmaceutical production equipment to avoid the cross-contamination and adulteration of medication products. So it's necessary to validate the cleaning procedures to assure safety, efficacy, quality of the subsequent batches of the drug product and regulatory requirements in Active Pharmaceutical Ingredients (API) product manufacture. This review article briefly discusses the scope and application of cleaning validation in the pharmaceutical industry.
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| Keyword:
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Cleaning validation, cleaning procedure, sampling technique.
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.238
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| Download:
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