In the pharmaceutical industry, making high-quality medicine is not just about the final product; it is about ensuring that every machine and every process works perfectly every single time.1 This review project focuses on the essential steps of Equipment Qualification (EQ) and Process Validation (PV), which are the "gold standards" for safety and consistency in manufacturing.2 The project explains the three main stages of checking equipment: Installation Qualification (IQ), which ensures the machine is set up correctly; Operational Qualification (OQ), which checks if the machine runs properly at different speeds or temperatures; and Performance Qualification (PQ), which proves the machine consistently produces the right results during actual production. Together, these steps make sure that the hardware is reliable.3 Beyond the machines, the project looks at Process Validation, which is the overall "recipe" for success. Following guidelines from regulatory bodies like the FDA and EMA, the industry is moving away from just testing a few batches and moving toward Continuous Monitoring. This means using modern technology to watch the production process in real-time.4 We also discuss the Risk-Based Approach, where companies focus most of their energy on the parts of the process that are most likely to affect the patient's health. By looking at current trends for 2026, this project shows how these rules help factories stay compliant, reduce waste, and, most importantly, keep medicine safe for everyone.5 Emerging Trends, the Digitalization, real-time monitoring, and continuous manufacturing are transforming validation practices. With tools like Process Analytical Technology (PAT) and artificial intelligence, the focus is shifting from static batch-based checks to dynamic, lifecycle-driven approaches that enhance efficiency, transparency, and sustainability.
Gorana et al. (Mon,) studied this question.
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