Validation provides evidence that a model or process is strong, powerful, and designed for its intended task. The objectives of validation include ensuring product quality, manufacturing consistency, process reproducibility, and demonstrating process robustness. Successful validations require comprehensive training programs, validation protocols, batch sheets, critical cGMP programs, and validation master plans approved by all departments including regulatory affairs. Major challenges in validation include ensuring sterility, critical cGMP programs, instrument calibration, preventive maintenance, cleaning procedures, supplier audits, and environmental and process monitoring programs. Types of validation include prospective, concurrent, and retrospective validation. Steps involve facility acceptance testing, IQ/OQ/PQ qualification, identifying critical parameters, validating the process, and documenting validation records including critical

1. Introduction to Validations Sanjay Shekar