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;