Process Validations (Dosage-Wise)

Process Validation (Dosage Wise) focuses on proving—using documented, scientific evidence—that each dosage form can be manufactured consistently to meet its predefined quality attributes. Because tablets, capsules, liquids, creams, and sterile products behave differently in equipment, mixing, heat transfer, and microbiology risk, validation must be designed around the specific dosage form, process steps, and critical parameters. This category covers dosage-form-specific validation strategy, PPQ planning, sampling and acceptance criteria, in-process controls, hold-time studies, cleaning interfaces, scale-up considerations, and continued process verification. Expect practical, shop-floor-ready guidance aligned with FDA 21 CFR 210/211, EU GMP Annex 15, and ICH Q8–Q10.