FAT Protocol

GOOD MANUFACTURING PRACTICE (cGMP)
1

Hello all,

i want to ask about FAT protocol, i want to travel and do FAT protocol for a new mahcines we bought in Germany,

any one can provide example for FAT protocol,

With regards

Michel Yalmizian

Validation Supervisor,

2

What type of machine is it?

Have you got a URS and a Functional specification.

Its very difficult to write a FAT protocol without requirements.

We have a range of templates for sale at Premier Validation www.premiervalidation.ie
http://www.premiervalidation.ie
if you would like to purchase a template.

Regards

3

The machine, is Blow Fill Seal Machine

Best regards

Michel Yalmizian

Validation Supervisor

4

Hi Michel,

Have you got a URS document detailing what the requirements are for this machine.

Who is the system owner, or who will be the system owner. Do they have knowledge of what they want the machine to do and what other machines or equipments this blow fill machine will interact with.

5

Hi Sir,

for information, i got the information and i know who is the system owner, i dont want to get complate protocol, i want some information about the cretical component which i have to check, and if u have empty protocl, to fill,

by the way, i know how to do DQ, IQ, OQ & PQ, but FAT protocol, its the first time i use,

Okey Sir, Thx for care,

Best Regard

Michel Yalmizian

6

Hello Michel,

It’s not as simple as giving you a template to work from, as my experience shows that each FAT protocol will be unique to the equipment type in question.

If it was a case of an IQ protocol then I would guide you in terms of what to look out for, but in terms of the FAT protocol, this will depend on the requirements from the URS that feed into the FS and DS, from those documents you can then develop your FAT protocol.

Have you got a URS, FS or DS?

7

Hi Michel

I have just come across your query.

I have done many Rommelag machines, but I have looked around and I can’t find an old FAT. However don’t be daunted, the FAT is generally laid out in a similar format to an IQ. You could take a cleaned out IQ and start from there. Get hold of their commission schedule (they have to give you a copy of this), and paste it into your new document, and edit into a protocol format.

Then have good look around the utilities. Ensure the utilities specified are used for the FAT. (sometimes they will use standard factory air on clean systems to test them).
If they do this, it can contaminate everything. So check all utilities.

We had troubles with the SIPCIP systems. I would make sure these are validated. I.e. witness a couple of cycles with active monitoring.

Pay attention to the software –

  1. Who is it by?
  2. Is it part 11 compliant?
  3. Request a risk assessment on the control system software, is it critical software.
    If the software calculates the SIP cycle then it must be critical, and you need all the documents to validate full life cycle.
  4. Is it bespoke software.

When you get the Commissioned schedule go through and apply cGMP to it.
Get certification for

  1. Lubricants used.
  2. Product contact materials.
  3. Temperature mapping of dies.
  4. Temperature mapping of supply tanks.
  5. The usual gauges and valves.
  6. All storage vessels.

That’s all I can think of at present, if you have a problem please feel free to email me.

Alex Kennedy

8

hello All, thx for all,

Dear Mr. Alex, thx for answering, and forgive me to ask many times :).

Okey if u have already did Fat for Rommelag machine, than i ll tell u the machine with model, which already purchaded and waiting to do FAT in the Rommelag, in Germany,

Now That we are going to inspect the BottlePack machine Type 321M (Blow Fill Machine).

u can visit

to check it.

we need from u data bank, for check points when we reach and check the operations, what are the check points, I have to inspect so as insure that we have purchased the right machine we need

With Best Regards,

Michel Yalmizian

9

Hi friend i belived you did your FAT for blow fill seall machine. actually i also needed for that . Can you send me a copy of FAT to mefor my reference. my mail id sivaseng@gmail.com.

i want to ask about FAT protocol, i want to travel and do FAT protocol for a new mahcines we bought in Germany,

any one can provide example for FAT protocol,

With regards

Michel Yalmizian

Validation Supervisor,[/quote]

10

The Factory Acceptance Test (FAT) is a major project milestone in a laboratory automation project where the equipment and/or system integrator demonstrates that the system design and manufacturing meets the contract or Purchase Order (P.O.) specifications (derived from the Functional Requirements Document (FRD), created by the system owner/project manager/project team).

The FAT is not a required document in the Qualification suite.
It is a smart thing to do and is intended to fix deficiencies before the equipment ships.

http://www.labautopedia.org/mw/Factory_Acceptance_Testing_(FAT)

[quote=validation eng]Hello all,

i want to ask about FAT protocol, i want to travel and do FAT protocol for a new mahcines we bought in Germany,

any one can provide example for FAT protocol,

With regards

Michel Yalmizian

Validation Supervisor,[/quote]