Year: 2026
Type: article
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.
Language: English
Subfield: Computational Mechanics
Field: Engineering
Domain: Physical Sciences
Open Access status: hybrid
OpenAlex ID: W7167463571