Validation Protocol Execution Tips – Top 10

How to execute a validation script successfully

So you have a validation protocol to execute and you want it to run smoothly without raising too many deviations and discrepancies (if possible). What is the best approach to take and what are the main things you need to look out for.

Here are my top 10 tips:

1. Ensure that the protocol has been written from an approved design document. There’s no point in developing tests from an unapproved FS (Functional Specification) or DS (Design Specification) if the design is going to change. Your protocol needs to reflect what is in your approved design document.

2. The person who is developing the protocol needs to understand what needs to be tested.

3. Ensure that you have sufficient time before you run the protocol to dry run it.

4. Treat the dry run as a real run, document all of your test results like you would the real run (You’ll be surprised what you find!)

5. If you have time, get an independent person to review your protocol, they will spot things you will never see.

6. Start the execution at the start of your day when you are fresh, not at the end when you are rushing and want to go home.

7. Ensure that all of the prerequisites have been performed before execution

8. Have deviation and discrepancy forms at hand to write them up as you go along (You will forget the details if you don’t)

9. Understand what is the difference between a deviation or a discrepancy (Or whatever terminology your company uses)

10. Attach any evidence you deem important

Having performed numerous protocol executions over the years, you’ll be amazed what you’ll forget to do, so it’s advisable to have your own checklist of items before you proceed.

Please add your own tips

In the comments section below please add any top tips you may have from your own experiences.

Looking for help with a project?

If you would like more advice on protocol executions or if you would like help with any upcoming projects please feel free to contact askaboutvalidation.com with your queries or contact Premier Validation.

5 thoughts on “Validation Protocol Execution Tips – Top 10

  1. Good article, although I would say that you dont always have the luxury of starting the protocol when it is convenient for you. I have found that when performing OQ and PQ on plant, you will need trained operatives available (as you wont be allowed to work on the equipment unspervised) and you have to work around them and not the other way round! I have had to execute protocols at the end of the working day, and I know people who have had to work during the night, as it was the only time operators were available!

    Would also say that for point 5, you would have the protocol reviewed and approved anyway under GMP. You must NEVER use any unapproved qualification documents!

    A tip:
    When working on a GMP plant ensure that you have been sufficiently trained to be allowed on plant without supervision (ie gowning procedures) as that can be a real pain if operators are busy and cant spare the time to escort and supervise you. Are you fully trained in the company’s procedures for writing and executing protocols, and deviations? If not – forget doing any validation work!

  2. Good article, although I would say that you dont always have the luxury of starting the protocol when it is convenient for you. I have found that when performing OQ and PQ on plant, you will need trained operatives available (as you wont be allowed to work on the equipment unspervised) and you have to work around them and not the other way round! I have had to execute protocols at the end of the working day, and I know people who have had to work during the night, as it was the only time operators were available!

    Would also say that for point 5, you would have the protocol reviewed and approved anyway under GMP. You must NEVER use any unapproved qualification documents!

    A tip:
    When working on a GMP plant ensure that you have been sufficiently trained to be allowed on plant without supervision (ie gowning procedures) as that can be a real pain if operators are busy and cant spare the time to escort and supervise you. Are you fully trained in the company’s procedures for writing and executing protocols, and deviations? If not – forget doing any validation work!

  3. It is a very nice article, as it reminds me actually the things we got during execution. We should do the dry run as real run and must be reviewed by any one else.

  4. It is a very nice article, as it reminds me actually the things we got during execution. We should do the dry run as real run and must be reviewed by any one else.

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