Whats more interesting is the impact of the life-cycle approach outlined in the document.
• Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
....
Manufacturers should:
•Understand the sources of variation
•Detect the presence and degree of variation
•Understand the impact of variation on the process and ultimately on product attributes
•Control the variation in a manner commensurate with the risk it represents to the process and product
(apart from validation procedure itself) It will certainly have impact on current procedures of annual product review, raw material supplier qualification, quality control processes etc.,
btw, has anybody started looking into impact/implementation of this guidance?