WHO Drug Information Vol. 24, No. 4, 2010

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WHO Prequalification ProgrammesWHO Drug Information Vol. 24, No. 4, 2010Research & Consulting, Inc. InterclarityResearch created a survey developmentprocess with both internal and externalcomponents that resulted in a surveywhose contents were relevant to manufacturersand, when assessed by thosemanufacturers, actionable by PQP. Thesurvey was undertaken with the clearunderstanding that PQP must operate inaccordance with respective WHO andother relevant international technicalstandards. It was also understood that theresults of the survey should neither serveto “lower” PQP’s technical standards norto “relax” the requirements for the sustainedquality, safety and efficacy of anymedicine that WHO had prequalified.Survey objectivesPQP identified three main objectives indesigning and conducting a survey ofpharmaceutical manufacturers:• Implement a comprehensive approachto assessing the level ofservice quality delivered to pharmaceuticalmanufacturers by PQP by(i) incorporating aspects of both servicedesign (process) and service delivery(people) and (ii) including servicesprovided during both the assessment ofproduct dossiers and on-site inspectionsof manufacturing facilities.• Maximize the diagnostic ability of thesurvey by incorporating questions thatuse manufacturer experience with majorregulatory agencies (US FDA, EMA,etc.) to measure expectations of servicequality and prioritize areas for improvement.• Provide a unified framework formeasurement. While the intent of theinitial survey of pharmaceutical manufacturerswas to include only thosecompanies that have had at least oneproduct prequalified, PQP was alsointerested in developing a survey formatthat could be extended to companiesinvolved for the first time (at some stagein the approval process or awaiting finalapproval) and companies that areconsidering participation.Survey development processWithout the benefit of previous selfassessmentefforts, PQP had little to workwith in terms of survey content in JanuaryFigure 1. Survey development294
WHO Drug Information Vol. 24, No. 4, 2010WHO Prequalification Programmes2010. The area of service delivery is richin both academic research and practicalapplication [1]; the area of service design,however, is specific to the organization,application, and recipients of the service.Figure 1 on page 294 illustrates theprocess used by PQP to identify andcodify important services related to theprequalification of medicines.A survey development process wasdesigned to obtain input from within theorganization and from regulatory andquality assurance professionals in pharmaceuticalcompanies. The overall aim ofthis process was to capture and includethe knowledge and experience of PQP sothat, when combined with the “voice ofthe customer”, survey contents would beboth relevant and actionable.Interclarity Research developed topicguides and facilitated discussions, interviewsand working sessions for bothinternal and external phases of theprocess. Internal working sessions, bothin conference call and in-person formats,were conducted with key PQP membersand groups (e.g. programme management,PQP assessors and PQP inspectors).Following the internal review, indepthtelephone interviews were conductedwith industry professionals familiarwith PQP. In both phases of the surveydevelopment process, the emphasis wason identifying, from a participant’s point ofview, important stages in the WHOprequalification process — aspects thatwork well and those that fall short ofparticipant expectation. To gain greaterclarity around important issues associatedwith service delivery, efforts weremade in the “voice of the customer” toidentify detailed descriptions of servicedelivery for both favourable and unfavourableevents, as experienced by PQPmanufacturer participants [2, 3].A list of candidate survey items related tothe PQP service process was developedfrom the findings of internal and externalqualitative research. Further analysis ofthe qualitative findings suggested thatservice delivery aspects of PQP would bewell-represented by items included in theSERVQUAL scale of service quality [4].SERVQUAL is a widely-applied scale formeasuring the quality of service delivery.Developed in the 1980s, it has beenrefined and applied over the past 25years.Survey construction and deploymentThe survey was divided into four mainsections:1. Experience with PQP.2. PQP Service Design (“process”).3. PQP Service Delivery (“people”).4. Other Aspects of PQP.The first section includes an introductionto the survey and questions that provideindicators and measures of previousexperience with PQP. Section 2 (ServiceDesign) is “custom” to PQP – developedas a result of a process review with PQPstaff and the series of interviews withpharmaceutical manufacturers. Thissection includes two multi-item questionson PQP aspects common to both assessmentand inspection environments, andtwo separate multi-item questions eachfor regulatory affairs and quality assuranceprofessionals respectively. InSection 3 (Service Delivery), measuringthe people component with SERVQUALrequires five separate multi-item questionseach for the assessment of productdossiers and on-site inspections respectively.The items in Section 4 are alsocustom to PQP and include measuresrelated to the advocacy, training andcompliance aspects of PQP.Incorporating both common and application-specificitems in a single surveymade deploying the questionnaire on theInternet advantageous. The appropriateprogramming logic was developed to295
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