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| Paper Title: | REVIEW ARTICLE ON CLEANING VALIDATION - AN IMPORTANT CONCEPT FOR QUALITY MANAGEMENT IN PHARMACEUTICAL INDUSTRY |
| Authors Name: | Yukti Patel , Khushi Chauhan , Dr. Shuchi Desai |
| Unique Id: | IJSDR2305273 |
| Published In: | Volume 8 Issue 5, May-2023 |
| Abstract: | Purpose of cleaning validation is becoming more significant as we deals with potent, complicated drug substances or product and complex biotechnology products. Pharmaceutical product and APIs can be contaminated by other pharmaceutical products or APIs, by some cleaning agents, any microorganisms or by other materials e.g. dust, lubricants, raw materials. Method Mainly cleaning is performed to remove or eliminate non-product contaminating material. In pharmaceutical industries, to ensure safety, efficacy and quality of drug products, care must be taken to avoid cross-contamination, adulteration of drugs or drugs with other active ingredients, contamination of microbiological origin or contamination by cleaning or sanitizing agents or product. It includes various levels of cleaning, cleaning procedure, sampling procedure, cleaning agent selection etc to ensure the efficacy of cleaning procedures to ensure that the patients are not put at risk due to cross-contamination. |
| Keywords: | Cleaning procedure, Cleaning Agent, level/ degree of cleaning, case study, Acceptance limits. |
| Cite Article: | "REVIEW ARTICLE ON CLEANING VALIDATION - AN IMPORTANT CONCEPT FOR QUALITY MANAGEMENT IN PHARMACEUTICAL INDUSTRY ", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.8, Issue 5, page no.1740 - 1749, May-2023, Available :http://www.ijsdr.org/papers/IJSDR2305273.pdf |
| Downloads: | 000223171 |
| Publication Details: | Published Paper ID: IJSDR2305273 Registration ID:206717 Published In: Volume 8 Issue 5, May-2023 DOI (Digital Object Identifier): Page No: 1740 - 1749 Publisher: IJSDR | www.ijsdr.org ISSN Number: 2455-2631 |
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