Good morning
In a process line via fermentation, after a change, it has been decided to requalify the equipment changed.
The approach used for qualification has been to divide the process line in several subsystems (e.g. subsystem 1, 2, and so on…) to covering a certain number of equipment of the line.
For example:
subsytem 2: C+ D + F + G
The question is: is it a correct GMP approach to split up a process line or is it better to consider only equipment impacted from the change for validation/qualification?
For your kind information these operations are not Sub systems.
They are unit operations of train with a great variability and complexity of operational method.
They have to be Seperated.
-The impact of systems must be nalaysed.
-Risks are analysed.
-Flow considerations and operatability conditions of Pressure, Flow rate, Temperature, Ph and Protein contents (Especially in columns mg of protein binding per mg of resin used), Cleanability etc must be conisdered.
-GMP controls including post installation requirements, Utilization and cleanability along side re-usability requirements must be evaluated as per compliance needs.
Risks must be properly mitigated during scale-up.
-Components of contact must be properly analysed.
-Impact assessment for overall train and individual unit operations must be done.
Most of the processes do not have a classic train. At some point of a Centrifugation might be changed to Dead end filtration due to new advances in filtration or reduction of capital equipment.
You need to understand what they do and how they impact other operations.
Ok I understand, anyway I would to make another question
Assuming that my process line is composed of an X number of equipments. It has been made a change consisting to installing a new equipment (e.g. A). For equipment A, I will execute IQ, OQ, PQ. The question is: regarding the old equipments, need I to make requalification? If it is so, what is the approach to use? ( …. I refer to fact that old equipments are already installed and so I imagine that the classic validation approach - IQ,OQ, PQ - should be not possible).
Can I have your opinion please?
[COLOR="#0000FF"][b]1. Get the drawings.
2. Get the Specification.
3.Create a proper protocol for IQ,OQ,PQ
4.Execute and sign the summary report.
Incase you do not have specifications or drawings-- Try to create one in place.
How to create:
Look at the system you are operating (The main system) -Take help of your engineer.(Mechanical Engineer is best otherwise a Chemical Engineer).
Create the drawings of the supportive systems and Drawings of the Ports/Connections those are attached to the main system.
3.Take help of your Electrical Engg staff and create the electrical and support system drawings.
Create specifications from the earlier runs you have made . Since its an old equipment it is common to have an operation range and sequence.
5.Make substantial documentation of DQ,IO,OQ,PQ and Validation summary report duly signed.
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This process must be mentioned as a sequential order in your VMP for equipment which are old and do not have documentation. I know from your earlier contact in this blog some of the equipment do not have documents.
In GMP there is requirement of Drawings and Specifications. It is a primary compliance requisite to maintain the quality of the product that has to be produced during the process using that system or equipment.