Asian Journal of Research in Chemistry

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Cleaning Validation in Pharmaceutical Industry


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1 YSPM’s Yashoda Technical Campus, Faculty of Pharmacy, Satara, 415003., India
     

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In pharmaceutical industries there is possibilities of contamination, cross contamination, microbial contamination, adulteration of drug with other active ingredient or contamination with other material like raw material, dust, lubricant, intermediates and air born particle.1 Cleaning validation validate the effectiveness of cleaning procedure for removal of excipient, product residue, degradation product and cleaning agent. Cleaning validation improves the potency and reliability of cleaning in given pharmaceutical production and equipment. The cleaning validation is essential part of the quality assurance. As a result, validating cleaning procedures is critical in the pharmaceutical sector to ensure the safety, efficacy, and quality of drug batches. The purpose of this review is to provide information about cleaning validation in pharmaceutical industry to provide better customer care and quality of product. This article will discuss the relevance of cleaning validation in the pharmaceutical sector, and it will do so in accordance with regulatory guidelines.2,3

Keywords

Cleaning validation, Cleaning method, contamination, Sampling techniques, levels of cleaning
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  • Cleaning Validation in Pharmaceutical Industry

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Authors

Poonam Khalate
YSPM’s Yashoda Technical Campus, Faculty of Pharmacy, Satara, 415003., India
Bharati Chaudhari
YSPM’s Yashoda Technical Campus, Faculty of Pharmacy, Satara, 415003., India
Vivekkumar Redasani
YSPM’s Yashoda Technical Campus, Faculty of Pharmacy, Satara, 415003., India

Abstract


In pharmaceutical industries there is possibilities of contamination, cross contamination, microbial contamination, adulteration of drug with other active ingredient or contamination with other material like raw material, dust, lubricant, intermediates and air born particle.1 Cleaning validation validate the effectiveness of cleaning procedure for removal of excipient, product residue, degradation product and cleaning agent. Cleaning validation improves the potency and reliability of cleaning in given pharmaceutical production and equipment. The cleaning validation is essential part of the quality assurance. As a result, validating cleaning procedures is critical in the pharmaceutical sector to ensure the safety, efficacy, and quality of drug batches. The purpose of this review is to provide information about cleaning validation in pharmaceutical industry to provide better customer care and quality of product. This article will discuss the relevance of cleaning validation in the pharmaceutical sector, and it will do so in accordance with regulatory guidelines.2,3

Keywords


Cleaning validation, Cleaning method, contamination, Sampling techniques, levels of cleaning

References