Abstract
INDUSTRIAL APPROACH ON PROCESS VALIDATION OF PARACETAMOL TABLETS 650 mg

*Utpal Misra, Dr. Debasish Bhattacharjee and Dr. Dhrubo Jyoti Sen

ABSTRACT

The goal of the research project "A Process Validation of Paracetamol Tablet 650 mg" was to verify the method used in the production of 650 mg paracetamol tablets. A thorough validation process is essential to guarantee the quality, safety, and efficacy of the tablets of the commonly used analgesic and antipyretic drug paracetamol. The study used a methodical methodology to test each step of the manufacturing of tablets, including ingredient weighing and blending, granulation, compression and packing. To guarantee constant product quality, crucial process variables like blending time, compression force and drying conditions were closely monitored and managed. Several batches of paracetamol tablets were produced and tested under established validation procedures and legal requirements. Content homogeneity, dissolving rate, hardness, friability, weight change, and disintegration time were among the validation matrices. In order to do the production process's dependability and reproducibility, a statistical analysis was carried out. The research endeavor successfully showed that the production of Paracetamol 650 mg tablets regularly met the established quality standards. The tablets displayed constant weight, rapid disintegration, adequate hardness, little friability, and uniform drug content. The tablets' breakdown time fell within the acceptable range, guaranteeing optimal medication release. Patients will obtain a safe and effective product thanks to the proven process' assurance that the paracetamol tablets, 650 mg, can be produced consistently and reliably. The findings of this study add to the overall quality assurance and control in the pharmaceutical sector, reiterating the significance of process validation in guaranteeing the quality, safety, and efficacy of products. The results of this study can be used as a guide by pharmaceutical companies that make Paracetamol tablets or other similar dosage forms. The results of the research can also serve as a reference for regulatory agencies as they establish and enforce quality standards for the production of paracetamol tablets.

Keywords: Process Validation, Paracetamol Tablets, Dosage strength, Manufacturing process, Quality control, Content uniformity, Hardness, Friability, Disintegration time, Dissolution rate.


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