Guidelines for Notification of Changes to Manufacturing Processes

The manufacturer shall inform PRI in writing of any proposed changes to the following, and the date to be accomplished 

a.	Manufacturing process changes
b.	Manufacturing equipment and machinery.  This does not include normal replacement of wear items or addition of new machines of brand, type, and model already in use at the approved facility.
c.	Movement of manufacturing facilities, machinery, and personnel to a new location.
d.	Business changes such as mergers, acquisitions by other companies, plant closings, and discontinuation of products.
e.	Formulation of raw materials (when applicable).
f.	Additional changes as defined by the QPG.

PRI shall consult with the QPG on the possible impact of the changes relative to any existing approvals.  Where existing approvals are impacted, the manufacturer will be advised of any action required, including the submittal of updated test data, to support continued approval.  As a minimum, PRI will retain the information for future audits.

 For more details see the applicable program document.