Validation

Validation means establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. The Major Phases of validation include Pre validation, Process Validation and Validation maintenance Phase.

  • Cleaning validation and process validation of biopharmaceuticals
  • Analytical method validation and computer system validation
  • Change control
  • Phases of validation
  • HVAC system validation

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