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Article of the month March 08 - Protocol Deviation Handling – A Premier Validation Te

Introduction:

So how do you handle all of those nasty deviations when you start to execute your Validation Protocols? Have you got individual deviation handling forms to account for deviations or do you just handle the deviations at the back of the protocol. Most companies have their own way of handling deviations, some prefer to have separate deviation handling forms while other like to have deviations as part of the main protocol.

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Thank you

Nice

Thank you will be of great help

Very useful, thanks for your efforts

Shortly, briefly, smartly…(reference, date, sign, trace, explanations…) etc…everything that’s needed to handle deviation’s record.
I don’t know…maybe is good to add corrective action description to prevent the next accident…in shortly words…just thinking…

Anyway, I think this is an Excellent work, thanks!!!:slight_smile:

cubica:D

Does anybody categorize their deviations? Major, Minor, Fatal, etc…then base who has to approve based on the category. What about type of failure, protocol generation error(PGE), executor error (EE), RAG (random act of God), AC failure. I have seen some really complex deviation procedures, and I prefer the simple yet somehow I think a lot of information is missing in the simple. Also, any thoughts on a Deviation Log…we use that so that deviations don’t just disappear.

What about having QA approve all deviations? Or just some? Then which ones?

What type of deviation requires approval before proceeding with execution?

[quote=meyert]Does anybody categorize their deviations? Major, Minor, Fatal, etc…then base who has to approve based on the category.
[/quote]

I agree Meyert categorization is important, how do you handle what is a major and what is a minor fault. Does it depend on the system in question? sometimes its hard to get agreement on what poeple see as major and minor deviartions. I find that some people try and justifty a minor deviation when it is a major one just to cut down on the work load involved.

[quote=meyert] What about type of failure, protocol generation error(PGE), executor error (EE), RAG (random act of God), AC failure. I have seen some really complex deviation procedures, and I prefer the simple yet somehow I think a lot of information is missing in the simple.
[/quote]

Agree again type of failure is important, I [FONT=Verdana]Intentionally left this example simple so that people could add in their own specific details, from company to company there is no overall template that can be used. [/font]

[quote=meyert]
Also, any thoughts on a Deviation Log…we use that so that deviations don’t just disappear.[/quote]

Yes a deviation log is an essential document providing a snapshot of all the deviations assocaited with the system

[quote=meyert]
What about having QA approve all deviations? Or just some? Then which ones?[/quote]

It’s like as if you are on the same project as me at the moment, I have always harped on about getting quality involved in all deviations from the start. If this does not happen then Quality end up slowing doen the review process as they dont understand the deviation and as a result will not sign off the protocol. I find that it can be useful to have a meeting with the interested parties to explain all the deviations before the review process begins

[quote=meyert]
What type of deviation requires approval before proceeding with execution?[/quote]

Any deviation that is deemed critical and prevents the next stage of the execution taking place.

Thats my 2 cents

i think i have mentioned it before but here i go…
discrepancies should be an attachment and not part of the original document. I cannot explain clearly but i have become accustomed to the discrepancy template which tends to keep things orderly and neatly placed. It is exhillarating to see such marvelous work; almost like poetry!

dear all,
does the template only for validation deviation or general deviation?
if that validation deviation, do you have template for general deviation?:slight_smile:

We have separate deviation sheets - 1 sheet per deviation. Very similar to your template!

We do categorise them: either as procedural deviations, or acceptance criteria.

So if you have a test written as “press the green ‘on’ button” and in fact what you need to do is turn the blue dial, that’s a deviation which is categorised as procedural.

If you need to meet an acceptance criteria of 90mm to 100mm and all your results are between 90mm and 108mm becuase the protocol had a typographical error (should have been 90mm to 110mm) which no approver noticed (it does happen!) then that is an acceptance criteria deviation.

We have different approvals then, with QA only approving deviations relating to acceptance criteria.

Seems to work for us.

Your post rocks!

[quote=gokeeffe]Introduction:

So how do you handle all of those nasty deviations when you start to execute your Validation Protocols? Have you got individual deviation handling forms to account for deviations or do you just handle the deviations at the back of the protocol. Most companies have their own way of handling deviations, some prefer to have separate deviation handling forms while other like to have deviations as part of the main protocol.

http://www.askaboutvalidation.com/featured_articles_expanded.php?uid=30

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Thank you[/quote]

While performing validation it is observed that some physical parameters limits are not complying as per documented evidence & deviation is raised for the issue so, 
  1. whether the validation for the batch will be cancelled & again fresh 03 batches will be considered as validation batch?
    2)Is it required to perform analysis for assay,dissolution for change in physical parameter limits based on deviation?
    If so can you help me out in getting any documented proof for that isssue?

[quote=sowmya]While performing validation it is observed that some physical parameters limits are not complying as per documented evidence & deviation is raised for the issue so,

  1. whether the validation for the batch will be cancelled & again fresh 03 batches will be considered as validation batch?[/quote]

What does your deviation say? In terms of the resolution for the deviation, how has it being resolved. It might be a good idea to state in the deviation that a revalidation of this test will be carried out to see if the test will pass the second time

[quote=sowmya]
2)Is it required to perform analysis for assay,dissolution for change in physical parameter limits based on deviation?[/quote]

I would think if it fails a second time then yes I would take a closer look at the assay