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@article{202627,
        author = {Mr. Aniket R.Patil and Mrs.Sandhya S.Ahire and Mr.Sujeetkumar I.Ahire},
        title = {Formulation and Process Validation of Oral Solid Dosage Form of Prothionamide Tablet},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {12},
        pages = {8742-8751},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=202627},
        abstract = {The World Health Organization (WHO) TB remains a major public health problem worldwide declared TB and is the second leading cause of death due to an infectious disease, second only to HIV/AIDS.Process validation is a requirement of the current GMP regulations for finished pharmaceuticals 21 CRF parts 210 and 211 and of the GMP regulations for medical devices 21 CRF parts 820 and therefore, is applicable to the manufacture of pharmaceuticals and medical devices. Prothionamide may be bacteriostatic or bactericidal in action, depending on the concentration of the drug attained at the site of infection and the susceptibility of the infecting organism. Three consecutive validation batches of Prothionamide Tablet were manufactured as per approved batch manufacturing record. The raw materials required for these validation batches were procured from approved sources and were taken up for manufacturing after testing and release by quality control. The raw materials were dispensed as per standard operating procedure. The process validation was carried out for the three batches.},
        keywords = {TB, WHO, Validation, Quality control, Bacteriostatic, Bactericidal, Prothionamide},
        month = {May},
        }