Process Validation: General Principles and Practices - This guidance outlines the general principles and approaches that FDA considers appropriate
elements of process validation for the manufacture of human and animal drug and biological
Recorded voice over for the presentation entitled FDA Trends: New Validation Strategies at the 2nd International Conference on Continued and On-Going Process Verification, 20th March 2017, Novotel Hamburg, Germany.
If you conduct process validation, you need to ensure that your results are valid. Beyond the regulatory requirements, statistical approaches will help you achieve the desired result - processes that produce only conforming material.
Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.