CT protocol


Hi
I implemented Electronic Batch Recording system for API
Also going for Computer systems validation as per GAMP

The problem here is, Client is asking to submit “COMMISSIONING TEST PROTOCOL (CTP)”, which i not even heard.

Can any one please suggest me:

what actually a CTP is?

At what stage of validation it required?

what is the difference between IQ and CTP?

What does a CTP should contain

I have not heard of this either, perhaps it is the same as a SAT - Site Acceptance Test?

Perhaps you are right. I have also never head about this term. It might be the commissioning report done at your site that your client is asking from you.

Hello!
Does anyone know or any other web site for complete ct protocols using GEHiSpeed NX / i? I am new scanner and I use this machine, I am seeing on the Internet for complete protocols from head to feet, but sad to say, I could not find any, so please help me.

I will take a guess that your client wants a “COMMISSIONING TEST PROTOCOL (CTP)” to use as you would use a Site Acceptance Test. In this interpretation of ASTM 2500 you would use this CTP to collect the data that would be used for IQ and OQ, because I will assume that there will be a QA reviewer on this documentation. I would ask the client for his Plan for the project as that will spell out what he wants in this CTP. The Plan could be the Validation Master Plan or a Commissioning Test Plan. Again I would guess that the CTP would contain similar tests as SAT, IQ and OQ.

Hi,
to my understanding, i think, i can suggest you an approach,
give me some information as well.
Q–Also going for Computer systems validation as per GAMP.
A-- which GAMP are you going to follow

Q–The problem here is, Client is asking to submit “COMMISSIONING TEST PROTOCOL (CTP)”, which i not even heard.
A–this could be your “Validation plan” for executing the validation at their facility.

Can any one please suggest me:

Q–what actually a CTP is?
A-- this is new terminology. However, it would include the regular documents but first of all your plan would give you a clear picture to the client. after providing them with thi you need to ask them for the URS. which would help you the coin the activity flow and also draw a GANTT chart for the same.

[quote=sagar]--------------------------------------------------------------------------------

Hi
I implemented Electronic Batch Recording system for API
Also going for Computer systems validation as per GAMP

The problem here is, Client is asking to submit “COMMISSIONING TEST PROTOCOL (CTP)”, which i not even heard.

Can any one please suggest me:

what actually a CTP is?

At what stage of validation it required?

what is the difference between IQ and CTP?

What does a CTP should contain[/quote]
Hi,

Commissioning is an approach followed by most of the companies at the time of installing an equipment. mostly engineering dept will do the commissioning of an equipment before performing any IQ. the IQ will be followed by successfull completion of commissioning.
In your case if the client is asking for commissioning CTP for a computer system then they may be looking for some kind of testing to be done before formal validation starts. this can be done in many ways and you can convence them by performing dry run of your IQ/OQ/PQ. hope this works.

(anyone disagree with my reply, Please feel free to correct me)