Process validation
Валидация процесса



Классический подход

Нормативные документы




Современный подход

FDA Guidance on Process Validation
Process Validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes the process validation activities in three stages:
• Stage 1 – Process Design: The commercial process is defined during this stage based on knowledge gained through development and scale-up activities.
• Stage 2 – Process Qualification: During this stage, the process design is confirmed as being capable of reproducible commercial manufacturing.
• Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.



•FDA Guidance for Industry , Process Validation: General Principles and Practices , January 2011, Current Good Manufacturing Practices (CGMP) , Revision 1
•ASTM E2537-08: Standard, Guide for the Application of Continuous Quality Verification to Pharmaceutical and, Biopharmaceutical Manufacturing;