Basics of validation
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
Basics of validation
- 1. Introduction to Validations Sanjay Shekar
- 2. Definition Validation provides the evidence that the model is strong and powerful, for a given task, that It has been designed .
- 3. Objective of Process validation Product Quality Manufacturing consistency and Process reproducibility Demonstration of process robustness Existences of QA systems with organization Ensure the properly trained and qualified person to produce the product.
- 4. For Successful validations A comprehensive training program Validation protocols Batch sheets Critical cGMP program
- 5. Pre Requisites for PV Validation master plan (VMP) OOS, Change control Program, training, SOPs. All Dept. Including regulatory Affairs Approval of Initial Documentation for Validation
- 6. Major Challenges In validations Sterility Critical GMP program An instrument calibration program Preventive maintenance pro Comprehensive cleaning pro Supplier audit pro Established process monitoring and environmental monitoring pro
- 7. Types of Validation Prospective validation Concurrent validation Retrospective validation
- 8. Steps in validating the process Facility Acceptances test IQ, OQ, PQ (DQ) Identify the critical parameters Validate the process Opportunity of experience deviation and product failures Validation record – Documentation Access/ predict critical control points of the process