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validation

A colorful graphic showing the Process Validation flow chart.

 We can help in demonstrating that a process, system, or equipment consistently produces a product that meets its predetermined specifications. This is essential to ensure the quality, safety, and efficacy of pharmaceutical products. 

Our consultants will assist in:

 

  • Developing a validation plan: This document outlines the specific tests and procedures that will be used to validate the process, system, or equipment.
  • Conducting the validation studies: This involves performing the tests and procedures outlined in the validation plan.
  • Analyzing the results: The results of the validation studies are analyzed to determine if the process, system, or equipment meets the predetermined specifications.
  • Preparing a validation report: This report summarizes the validation studies and their results. It also includes conclusions and recommendations.

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