The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that new drug, medical device, medical equipment, and rel

Introduction. Concept of Qualification / Validation. Re-Validation. Responsibilities. Facility Description. Description of Building. Utilities Description. Validation Program Overview. Calibration Program Summary. Preventative Maintenance Program Summary. Key SOPs. Validation of Building Test Functions and Acceptance Criteria. Validation of Utility Systems Test Functions and Acceptance Criteria. Process Description: Building A- Dry Oral Products. Process Description Building B- Liquids and Semi Solid Products. Process Description: Building C- Injectables. Qualification of Process Equipment Test Functions and Acceptance Criteria. Validation of Support Process Test Functions and Acceptance Criteria. Quality Assurance / Control Laboratory Validation. GMP Procedures and Programs. Drawings for Building A. Drawings for Building B. Drawings for Building C.