Abstract

KEY ROLE OF ANTIBIOTICS IN HEALTH CARE SYSTEM

*Prachi Nagpal, Kunal Kaushik and Mayank Bansal

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Abstract

The development of a drug product is a complex endeavour, encompassing phases such as drug discovery, laboratory testing, animal studies, clinical trials, and regulatory approval. Process controls, including inspection of raw materials, in-process monitoring, and setting targets for the final product. Process validation, as mandated by the cGMP regulations, is essential at both general and specific levels as outlined in parts 210 and 211. Analytical estimation and process validation of Ciprofloxacin HCl tablet dosage form would be carried out. Three consecutive batches of Ciprofloxacin HCl are F1, F2 & F3 will be taken for process validation studies. All the critical parameters would be evaluated for fixing the optimum process parameter. Analytical evaluation of Pre-formulations parameters, Post formulations parameters, preparing validation protocol, Execution of validation protocol.

Keywords: Validation, Antibiotics, Ciprofloxacin, Tablets, Analysis.