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@article{206436,
        author = {Ravina Rajpurohit and Aparna Arora and Anju Goyal and Hitesh Kothari},
        title = {VALIDATION OF CLEANING PROCEDURE FOR OBETICHOLIC ACID TABLET PRODUCTION},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {2},
        pages = {1951-1957},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=206436},
        abstract = {Cleaning validation is an essential requirement in pharmaceutical manufacturing to ensure that equipment used in production does not carry residues from previous batches that could compromise product quality and patient safety. The present study evaluates the effectiveness of a cleaning procedure applied to equipment used in the manufacture of obeticholic acid tablets. Considering the drug’s potency and low aqueous solubility, a worst-case approach was adopted. Residue assessment was performed using both swab and rinse sampling techniques, followed by quantitative and microbiological analysis. Acceptance limits were defined using regulatory approaches such as the 10-ppm criterion and health-based exposure limits. Results obtained from three consecutive validation runs confirmed that the cleaning procedure consistently reduced residues and microbial contamination to acceptable levels. The findings demonstrate that the validated cleaning process is reliable, reproducible, and compliant with current regulatory expectations.},
        keywords = {Cleaning validation, Obeticholic acid, cross-contamination, MACO, pharmaceutical quality.},
        month = {July},
        }