Learnaboutgmp Community

Validation Protocols/ Reports

What is the best practice when it comes to validation protocols and reports. :confused:Do you need 2 separate documents or can you cover the report in the protocol if your test sheets are attached to your protocol? Are there any guidelines on this.

My preference is for 1 protocol and 1 report detailing all the work.

Any thoughts or suggestions.

Thank you

Austin

I have always used separate documents for report and protocol.

Not sure if there are any guidelines on this.

I think it’s cleaner to have individual ones.

Just personal preference though!

we incorporate our test sheets within the protocol, so our reports for each qualification phase are merged with those respective protocols. Going forward, we intend to stick to this approach, but a have a final indpendent report summarising the full 4Q validation activities…

Going by definitions of what a protocol and report are.

  1. validation protocol. (FDA) A written plan stating
    how validation will be conducted, including test
    parameters, product characteristics, production
    equipment, and decision points on what constitutes
    acceptable test results.

  2. test plan. (IEEE) Documentation specifying the
    scope, approach, resources, and schedule of
    intended testing activities. It identifies test items, the
    features to be tested, the testing tasks,
    responsibilities, required, resources, and any risks
    requiring contingency planning.

  3. test procedure. (NIST) A formal document
    developed from a test plan that presents detailed
    instructions for the setup, operation, and evaluation

  4. Test report (IEEE) a doc describing the conduct and results of the testing carried out for a system.

As it is a requirement to plan what you are going to do, then a protocol with incorporated test sheets is needed.

The person executing the tests uses the protocol as the instruction of what to do and the test sheets record the results.

The norm would be after the testing is complete a brief description stating the outcome of the test and referencing the protocol followed.

So my view is
You end up with one report containing the protocol and test results.
Not the other way round a protocol containing the test results.

[quote=hugh8]
So my view is
You end up with one report containing the protocol and test results.
Not the other way round a protocol containing the test results.[/quote]

Agree but is the report not a separate document detailing the results of the executed protocol?

MAny thanks for your reply. It seems that it is really company preference.

I agree with the separation of each document.

Austin

[quote=Austin]MAny thanks for your reply. It seems that it is really company preference.

I agree with the separation of each document.

Austin[/quote]

Yeah i do agree too, to create separate protocol and report.

Thanks

can anybody pls provide me detailed notes on "validation protocol and reports"
its prevaling status all over the world,advance techniques in use and approaches by renowned scientist.
thanx