PROCESS VALIDATION OF PHARMACEUTICAL DOSAGE FORMS: A SCIENTIFIC REVIEW

Siddhi Sartape*, Pushpanjali Shinde, Shrikrishna Baokar and Rajendra Patil

ABSTRACT

Ensuring product quality is a fundamental requirement in pharmaceutical manufacturing. Process validation plays a crucial role in building a robust production system capable of consistently delivering drug products that meet predetermined specifications and safety standards. Validation is not merely an end-stage quality check; it is a lifecycle activity that begins at the process design stage and continues through routine manufacturing. Process validation involves comprehensive documentation and scientific evidence to confirm that a manufacturing process operates within defined parameters and produces high-quality drug substances and products. This review outlines the principles and regulatory expectations surrounding pharmaceutical process validation, including types such as prospective, retrospective, concurrent, and revalidation. Additionally, validation approaches for solid oral dosage forms (e.g., tablets), semisolid forms (ointments and creams), and aerosol formulations are discussed, with emphasis on critical process parameters, quality attributes, and control strategies. In accordance with Good Manufacturing Practices (GMP) and regulatory guidelines from the FDA, EMA, and WHO, process validation supports product integrity, enhances manufacturing efficiency, and minimizes risks of batch failure and product recalls. This article serves as a comprehensive guide to the scientific, practical, and regulatory aspects of process validation across pharmaceutical dosage forms.

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