Prerequisites for Successful Validation

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Journal of Validation Technology

240

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alidation was hinted in the1960s, almost four decadesago. What has changedover the last 30 to 40 years? Has theoverall understanding of the termimproved? Have all responsiblefirms truly embraced validation?Are they doing everything withintheir power to make validations asuccess? Unfortunately not. Whilevalidation is a very necessary ele-ment of any firm that falls under thescrutiny of the governing regulatoryagencies – both United States andforeign – it has not received the re-cognition it deserves.So often, departments chargedwith conducting validations areforced into an exiled status, as op-posed to being embraced.•How can validation profes-sionals bring about a change?•How can they assure that prop-er events occur to achieve suc-cessful validation?•Why has validation been so misunderstood forthe last four decades?•How can validation resources go about planningand executing validations?•How can a firm be assured that its resources havewhat it takes to successfully complete a valida-tion? There are thirteen tools or elements that arerequired for conducting effective validations.Each are presented and dis-cussed in the following sections of this article.

1. Understanding

Perhaps the single most impor-tant element required is a good un-derstanding of what validation is.This understanding actually goesbeyond the basic definitions of val-idation, beyond the concept of “requiring a minimum of threeruns.” This understanding must beanchored by sufficient years of practical experience and knowl-edge. It will permit sound and logi-cal decisions, even under the mostintense situations.Given the fact that regulated drugmanufacturers must perform valida-tions, it is very important that thisunderstanding be shared throughoutthe organization. Afirm derives littlebenefit if a thorough understandingof validation remains within the val-idation department, and there is ab-solutely no concept of the term within the departmentresponsible for approving the validation budget.So often, validation becomes alienated from therest of the company due to a lack of thorough under-standing. Why can’t the laboratory use the piece of equipment undergoing validation? Why can’t thefacility be used before the laboratory has completedanalysis of the microbiological data? Why are vali-

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A firm deriveslittle benefit if athoroughunderstandingof validationremains withinthe validationdepartment,andthere isabsolutely noconcept of theterm within thedepartmentresponsible forapproving thevalidationbudget.

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Charlie Neal

Diosynth-RTP (an Akzo Nobel Company)

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Prerequisites forSuccessful Validation

dations so expensive? Naturally, if the entire compa-ny is fairly educated on what validation entails, lesstime will be required defending validation’s actions.Good understanding has to be disseminatedthroughout the entire organization. Of course, it hasto begin with the group charged with performingvalidations. In the end, it is up to the firm to realizethe importance of assuring that this understanding isshared among the key groups.

2. Communication

One of the best methods of improving environ-mental understanding is through communication.Communication is essential for any activity that re-quires more than one resource to complete. Hopefullythis point is understandable considering that conduct-ing effective validations involve multi-departments.• When is validation of unit xyz scheduled to begin?• How many resources will be required?• When do protocols have to be approved?• At what sites will sampling occur?These are typical questions that can best be an-swered through communication. One of the keys toproper communication is locating the right commu-nication vehicle. Most organizations communicatethrough one or more of the following methods:• Conversations• Memos• Periodic meetings•Training sessionsWhile adequate communication can be obtainedthrough either one of the above, the ideal environmentwould have all of the above. The point is that

some

communication is better than

no

communication.

3. Experience

Afirm must have resources with solid validationexperience in order for their validation program to besuccessful. Can the average person be expected toperform open heart surgery without proper study/pre-paration? More simply, can the average person beexpected to win a bike race if they have not yet learn-ed to ride a bike? If one has not shouldered the re-sponsibility of performing an Installation Qualifi-cation (IQ) on a pump, will they be able to executethe Operational Qualification (OQ)? Well, this sameconcept holds true for a person charged with plan-ning or executing validations.The point is that the more responsibility a personhas shouldered for validation, the greater his experi-ence will be. Likewise, the greater his knowledge,understanding and logic will be. For example, a sea-soned validation resource, in the midst of completinga validation, encounters a failure that will necessitatevalidation to be repeated in its entirety. Work ing through this series of events will undoubtedly providethe resource with experience in dealing with failureand resolving problems.Now, is it reasonable to expect an inexperiencedstaff to perform a solid validation? In most cases, no.However, with proper coaching and consultation,some successes can indeed be realized.

4. Cooperation and Focus

Why is there a need for cooperation in order for per-sonnel to conduct effective validations? Let us firstunderstand the “multitude” of departments that some-times interact during the course of executing validation-Program/Project Management, Accounting, Validation, Quality Control (QC), Project Engineering, Process Engineering, Quality Assurance (QA), Metrology, Fa- cilities, Regulatory, etc. It is safe to assume that thesedepartments have an array of priorities, and typicallythey are not the same as validation’s.Let us focus on the example of a professional bas-ketball team. Their objective parallels that of a multi-disciplined / inter-departmental validation team-both strive for success. The assumption is that each teammember is critical to the overall success of the team.Assume that both teams are in the fourth quarter orfinal phase of their event-the basketball team in thechampionship game, and the validation team execut-ing the final event prior to initiating product com-mercialization. If the center on the basketball teamloses his desire to play defense, and/or pass to histeammates, how successful will that team be? Thesame concept applies to the validation team. If some-one fails to approve the protocol or to sample per theprotocol, the cost of validation will undoubtedlyincrease. Why? Simply because more time will bespent seeking approvals. Likewise, time will be spent justifying and writing the explanation for why a

May 2003 • Volume 9, Number 3Charlie Neal, Jr.

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Journal of Validation TechnologyCharlie Neal, Jr.

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sample was not initially collected. Cooperation isessential and critical. Therefore, each member mustbe focused on the overall tasks, and willing to coop-erate 100%.

5. Resources

In reality, it does not matter how much knowl-edge, experience, and understanding a firm has, if they don’t allocate the proper resources for conduct-ing effective validations. What do we mean by re-sources? By resources, we of course mean personnelwho will plan and execute, equipment on which val-idations will be performed on, materials, with whichto conduct validations, laboratories that will performnecessary analyses, funding to payfor the validations, and TIME inwhich to perform validations. Val-idations can often begin, but cannotbe completed if any one of these re-sources are missing.As an example, consider an auto-clave on which a new load configu-ration requires validation. Awindow has been created by the equipmentowner (time, equipment), the owner’sdepartment has provided all the human resourcesrequired (personnel), and the lab is ready for samples(laboratories). However, the validation team hasbeen advised that the laboratory does not have the re-quiredspore strips (materials) in inventory. Can validation be completed? No, since spore strips arerequired in order to assess the efficacy of the cycle.The same holds true for any resource required forvalidation.

6. Budget

It is important to understand that a successful val-idation must be done to completion. Typically, it should not be limited by a budget assembled by per-sonnel who have no appreciation for what is requiredto successfully complete validation. Further, it is im-portant to understand that validations cost money. Arule of thumb has been that equipment qualifications,which are integral parts of validations, are typically10-20% of the cost of the capital equipment. Where do these charges come from? Typically, these charges are related to the time to execute the following costinitiatives: • Investigate/acquire information• Conduct meetings• Plan• Put the plan into words (protocol)• Execute the plan•Troubleshoot and/or resolve problems• Summarize the effortConsider how projects are funded within corpo-rations. Each department has to prepare an annualbudget for anticipated expenses. It is very importantthat the anticipated costs are shared with upper man-agement to assure that ample support-or funding-exists. Now consider validation and the bulletedactivities listed above. From a corporate standpoint,each one of these elements require time, and there-fore have an associated cost.Thus, it is essential that they are reflected in thevalidation budget.

7. Plan

Aprofessional sports team cannot be expected towin the championship without a plan. Most of theseteams refer to their plans as plays. Without plays, agood offensive football team cannot hope for suc-cess against another good team’s defense. For exam-ple, if the quarterback does not know where hisreceivers will be, how often would he be able tocomplete a pass? If a running back did not know histeam’s blocking strategy, how many yards would heaverage per play? Per game? Per year?Bear in mind, that conducting validations withinmost companies will involve a number of depart-ments and disciplines. These disciplines need a planin order to get good team synergy. Further, this planmust be communicated in order to be accepted andsuccessful.

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So often,the wait for the receiptof analytical results causes theentire validation project to cometo a halt.Why? Becausevalidations are based uponthe results obtained.

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