ADVANCED PROCESS VALIDATION IN SOLID DOSAGE FORMS

Abstract

Process validation is a critical component of pharmaceutical manufacturing that ensures consistent production of high-quality products. In solid dosage forms such as tablets and capsules, validation helps maintain uniformity, safety, efficacy, and stability of the product. It provides documented evidence that manufacturing processes perform effectively and reproducibly within predetermined specifications.
The present thesis focuses on process validation in solid dosage forms and explains various stages involved in validation such as process design, qualification, and continued process verification. It also includes different types of validation, equipment qualification, critical process parameters, critical quality attributes, and regulatory requirements.
This thesis highlights validation procedures used in tablet manufacturing including mixing, granulation, drying, compression, coating, and packaging. Proper validation minimizes batch failures, improves process control, reduces production cost, and ensures compliance with Good Manufacturing Practices (GMP).

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