Re: Process Validation - Product Transfer to Different Facility
Our west coast plant is coating a blade for medical end use. The line is transferring to the midwest, and the customer is asking for our plan to capture process validation. I am in aerospace, so the lingo is all new to me.
If the process is the same, and equipment is similar (but not the same pieces) which qualifications are applicable: IQ - Installation Qualification, OQ - Operation Qualification, & PQ - Process Qualification? Any examples of document formats?
All help is appreciated
Welcome to the Cove
and yes, as suggested by you, I am smiling too
Let me give you the basic definitions of DQ, IQ, OQ and PQ and then that will be more clearer. The entire requirement becomes necessary because of one point that you have pointed out -
similar but not same
The qualification and validation process is done to establish and provide
documentary evidence that:
The
premises, the supporting utilities, the equipment and the processes have been
designed in accordance with the requirements of GMP. This normally
constitutes Design Qualification or DQ.
The
premises, supporting utilities and the equipment have been built and
installed in compliance with their design specifications. This constitutes Installation Qualification or IQ.
The
premises, supporting utilities and the equipment
operate in accordance with their design specifications. This constitutes Operational Qualification or
OQ.
A
specific process will
consistently produce a product meeting its predetermined specifications and quality attributes. This constitutes Process Validation or PV. The term Performance Qualification or PQ may be used
also.
The next question is when to qualify and validate -
Any aspect of, including significant changes to, the premises, the facilities, the equipment or the processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated.
In your case, since the entire line is being transferred, you would have to start right from the Installation Qualification to confirm if the installation is being done correctly in the first place.
Hope this clarifies.