Study of process validation parameters of tablet manufacturing
1 Scholar Department of Pharmaceutics School of Pharmacy YBN University Ranchi,
2 Associate Professor Department of Pharmaceutics School of Pharmacy YBN University Ranchi,
3 Dean School of Pharmacy YBN University Ranchi, Jharkhand-India.
Review
Open Access Research Journal of Life Sciences, 2026, 12(01), 001–008.
Article DOI: 10.53022/oarjls.2026.12.1.0021
Publication history:
Received on 20 May 2026; revised on 27 June 2026; accepted on 29 June 2026
Abstract:
Validation of processes in the pharmaceutical industry is important because all tablets manufactured will consistently meet specified quality assurance (QA) criteria, safety specifications, and regulatory compliance. This study is designed to examine process validation studies on the manufacture of tablets to determine how critical parameters of the process impact the quality attributes of the tablet. Tablets were manufactured in three separate validation batches using a wet granulation method for production and the following parameters were evaluated during the tablet manufacturing process, along with the finished product, granule flow properties, blend uniformity, weight variations, hardness, thickness, friability, disintegration times, dissolution profile, and assay. The tablet manufacturing process was accomplished using the following sequence: dispensing, sifting, granulation, drying, milling, blending, compression and coating. During the study, the following critical parameters of the process were optimized and monitored, mixing time, granulation endpoint, drying temperature, compression force, and coating conditions. The overall results of the study showed that all three validation batches produced acceptable or satisfactory process reproducibility and were therefore built in accordance with predetermined standards that were acceptable (allowed). The weight of the tablets varied from 495 mg to 505 mg, hardness ranged from 6.5 to 7.2 kg/cm², the friability of the tablets was below 1%, the time taken for disintegration was less than 10 min and the dissolution of the drug occurred at greater than 85% in 30 mins after administration. Statistical analysis of the data indicated low levels of inter-batch variability thus confirming the reliability of the tablet manufacturing processes, demonstrating that the tablet manufacturing process was capable of producing tablets with consistent quality and was in a state of control. Process validation is an important tool for filling in quality assurance for the consistent manufacturing of products, compliance with regulatory requirements and the continuing improvement of the pharmaceutical tablet manufacturing process.
Keywords:
Process validation; Tablet manufacturing; Critical process parameters; Quality assurance; Wet granulation; Validation batches; pharmaceutical quality.
Full text article in PDF:
Copyright information:
Copyright © 2026 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0