PROCESS VALIDATION STRATEGIES FOR PEG 3350 EFFERVESCENT POWDER: CURRENT ADVANCES, CRITICAL PROCESS PARAMETERS, AND REGULATORY PERSPECTIVES

Pharmaceutical process validation plays a fundamental role in ensuring the consistent production of safe, effective, and high-quality medicines. This review has highlighted the importance of adopting a lifecycle-based validation strategy for PEG 3350 effervescent powder by integrating scientific process understanding, Quality by Design (QbD), Quality Risk Management (ICH Q9), and continuous process verification.The discussion emphasised the significance of controlling Critical Process Parameters (CPPs) and monitoring Critical Quality Attributes (CQAs), particularly for moisture-sensitive formulations. Sequential Fluidized Bed Drying followed by Vacuum Tray Drying was identified as an effective moisture reduction strategy that improves product stability while preserving the physical characteristics of PEG 3350. In addition, analytical evaluation, environmental control, and comprehensive regulatory compliance were shown to be essential for maintaining consistent product quality throughout manufacturing.From an industrial perspective, robust process validation enhances manufacturing efficiency, minimises batch-to-batch variability, reduces product rejection, and supports compliance with international regulatory expectations established by the FDA, EMA, WHO, ICH, USP, and BP. The adoption of advanced technologies such as Process Analytical Technology, Artificial Intelligence, Machine Learning, digital manufacturing, and continuous manufacturing is further transforming pharmaceutical production into a more intelligent, predictive, and quality-focused process.Despite these advancements, challenges including moisture sensitivity, commercial scale-up, implementation of continuous validation, and integration of advanced digital technologies remain important areas for future investigation. Continued research should focus on developing smarter process control strategies, AI-assisted predictive models, sustainable manufacturing practices, and advanced real-time monitoring systems to further strengthen process robustness.

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