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So you’ve finally reached the stage where you are now free to execute your validation protocol after months of development, review and approval. It would be a real shame at this stage if the execution went horribly wrong and the protocol was strewn with errors and deviations….after all this hard work this is what you will be judged on so it’s critical that you take the execution aspect very seriously.

Below are my top 10 tips to help you achieve execution success!

Tip 1: Develop the Protocol from Approved Design Specifications

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.

This is especially significant when developing software validation test scripts, for equipment qualification the tests may come from approved OQ and PQ protocols that are not linked to requirements….the we’ve always done it this way approach!

Tip 2: Test Objectives Clearly Defined

The tests should be written in a manner where the objectives are clearly defined and each test is unambiguous. Having well defined requirements will assist with this but if you don’t you should make every effort possible to craft each test step in a manner that is easy to understand.

Remember if may not always be you who are executing the script you developed so keep that in mind throughout the development process.

Tip 3: Sufficient Space in the Protocol

If you are not executing your protocol electronically then you are using the traditional paper approach of handwriting on the paper print-out. If this is the case make sure that you leave sufficient space in the expected result columns to add sufficient test results.

There is nothing more frustrating for the reviews to have to use a magnifying glass to see what you have written.

Tip 4: Tester needs to have Testing Knowledge

Has the person who is developing the test script prior experience with this type of work? Testing is a skill and is one that is often overlooked. Great testers don’t just test the obvious functions they think outside the box and ensure other angles aside from the intended use are covered.

Tip 5: Time to Dry Run

It may not always to be possible to dry run your test script before the official execution but good project managers will factor in dry run executions as part of the project timelines. It’s amazing what you will find wrong with your script if you take the time to dry run it before official execution.

This may seem like extra work at the time but it will save you a huge amount of work overall. 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!)

Tip 6: Make Sure the QA Review is not just a Formatting Review

Does the QA person pre-approving your protocol really understand what they are reviewing? I have seen it time and time again where the QA review turns into a formatting review where you get the document back with only formatting changes. If that is the case either your protocol is perfect (which is never the case) or the QA person is not technical enough to really understand what is been tested.

For example if you are testing for Part 11 compliance does the QA person know what that means?

Tip 7: Execute in the Morning

This may seem like an obvious tip but try and schedule your execution times in the morning when you are fresh and not rushing to get home. Give yourself sufficient time to execute, this isn’t a speed test you need to take a quality driven approach to your executions.

Tip 8: Remember to Read the Pre-Requisite Section Carefully

Ensure that all of the pre-requisites have been performed before execution. Many protocols have a pre-requisite section where set-up data needs to be configured before the actual testing can commence.

There is little point in rushing through the protocol only to find out mid-way through the test that you forget to input the set-up data that allows you to execute the test.

Tip 9: Easily Accessible Deviations Forms

Deviations are part and parcel of any validation execution, its human nature to make mistakes and making mistakes with validation protocols is no different. Whether they come from the actual or expected results or from not executing a test correctly it is good practice to have a bundle of deviation forms at hand to populate at the time the deviation occurred.

This will ensure that you remember exactly what the issues were instead of trying to recall later.

Tip 10: Attach Test Evidence Correctly

Usually test evidence needs to be generated to support validation executions, from print-outs of equipment pressure and temperatures to screen-shots of software applications. Ensure that each additional print-out or attachment is numbered correctly and also references the protocol number.

You need to be able to pass the drop test!

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  • davidj

    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!

  • Muzaffer

    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.

  • rama

    Very nice article . definately useful for the validation perfromers .

  • matt

    Very practical advise – especially tips 2,5,8 and 10.

    Thanks

  • john saenz

    One often forgetten point, but in my opinion important point is ORGANIZATION…that is create a binder or package to pre define what you are to collect in the field…i.e. cal certs, screen shots, software back ups, test results sections….often during execution, there is not enough time to ensure that the correct screen shots, or data sheets are collected or data sheets are are fully completed, or BI request / Lab request paperwork is not completed,
    Organize the binder…it will amke for a much easier report closure session
    john saenz

  • Koushik Rajaram

    It is a very nice article, informative and concise. Would you mind to publish/share information about how to prepare equipment qualification and process validation protocols and what are the guidelines which we need to refer to before preparing such a protocol and report.

  • shital y

    Pls review this site:http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/validation/gui_29-eng.php and references listed below it may help.
    Moreover , koushik as you have not specified for what type process validation eg. dosage form its hard to guide you further.

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Training of personnel on deviation reporting and deviation handling is essential to a successful implementation of deviation management. All personnel must have a clear understanding of the deviation concept on all level of operation.

From a cleaning employee to a top level manager, everyone in the organization must apply deviation management procedure or instructions.

In order to do that, it must be mandated that all employee will attend at least once per year training on how to identify and report deviations.

 

The Three Levels

It is important to keep record of all the training’s performed in order to demonstrate to auditors that all personnel in the organization are competent and can report, handle, and/or manage deviations in a swift and accurate manner.

There are three levels of training on deviation management:

  1. Level 1: Identifying deviations and reporting them
  2. Level 2: Deviation Handling and Investigating
  3. Level 3: Deviation’s Corrective and Preventive Action

Level 1: Identifying Deviations and Reporting Them

  • This level of training should be mandated for all employees.
  • In this level, the trainee must learn how to notice and identify a course of actions or results which might indicate that something deviated from the standard and approved procedures in the quality management system.
  • This particular skill is crucial to the deviation reporting.
  • The trainer must spend considerable time developing attention to details in trainees. This particular competency forms the basis on which the trainer will build the trainees knowledge of deviation management.
  • The second obstacle to overcome is to make the employees understand that deviation reporting isn’t the equivalent of mistakes reporting.
  • In my experience, at first, many employees will see deviations as a way for the top management to record their mistakes for performance evaluation and bonus estimation.
  • The trainer must explain that it is the opposite of that concept, deviation reporting is your chance to express your interest in preserving the quality of the product or the service you provide in your organization.
  • It asserts your loyalty to the a quality based product and/or service and your devotion to the company’s standards.
  • Level 2: Deviation Handling and Investigating

    • This level of training is exclusive for management staff, including both lower and upper management.
    • In this level of training, the trainer must focus on investigational techniques and root cause analysis.
    • The basis of the training is risk analysis. The trainer must be an expert in risk identification, assessment, evaluation, reduction, and communication.
    • Other essential techniques include listening skills, communication, team work, and meeting management. These skills must be honed by the trainees during the training and during normal working hours.
    • The trainer must emphasis that this level of training is a mere introduction into deviation handling and that practice makes perfect. The reason is no one can develop all the skills necessary for investigating and solving complex deviations in one training module. The experience of the person practicing those tasks is the ammunition that would help him or her succeed at his or her job.

    Level 3: Deviation’s Corrective and Preventive Action

    • This level of training is exclusive to quality assurance personnel and upper management (including other department’s managers).
    • The aim of this training is to develop the ability of trainees to find the most efficient and effective actions to correct and prevent the deviation from reoccurring.
    • As we mentioned in 3.1.8. there are several points to consider when taking corrective and preventive actions. These points must be included in the training.
    • The trainer can be someone with experience with the applied procedure for corrective and preventive action in the organization and it would be better if he or she is experienced in risk management as mentioned in level 2 training.
    • If the training is being conducted for the first or second time, the trainer must emphasis to upper management that the trainee will need time to develop the experience necessary for them to create systematic actions with little to no side effects.
    • This training must conclude that the personnel required to decide the corrective and preventive actions must convene periodically in order to discuss the effectiveness of their actions and see what they can improve in their decision approach.

    Optional Training Sessions

    There are several competencies which are essential to successful deviation management, time management is one, communication management is also an essential feature which is greatly needed for the continuous and effective follow-up of deviations throughout the organization.

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Choosing a Vendor

The same methodology needs to be dedicated when choosing a vendor for your business. Not only will you be purchasing their products or services, but you will also be dealing with them on a regular basis hence your personal relationship most also be strong.

Regulated Environment

When working in a regulated environment one of the key questions that needs to be considered is will the product of service affect your product quality. If the answer is yes then it is paramount that you can trust your supplier/vendor and the quality of their product or service

Supplier Qualification Online Course

This module is taken from our course on Supplier Qualification.

 

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