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

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WHO Prequalification ProgrammesWHO Drug Information Vol. 24, No. 4, 2010display the questions common to allrespondents and the application-specificquestions (i.e. assessment of productdossiers and on-site inspections) only tothose respondents with the relevantbackground and PQP experience. Inaddition, since a relatively large numberof respondents in both the Indian andChinese markets were anticipated, nativelanguage versions of the questionnairefor these two markets were made available,along with the English languageversion. An option was included in thesurvey introduction that allowed respondentsto select a language option.MeasurementWHO service performance was measuredusing a 7-point rating scale, where a “1”indicates “low performance” and a “7”indicates “high performance”. The numbers2 – 6 are varying degrees in between.To increase the diagnostic value ofthe survey results, two supplementalquestions [4] were included to describemanufacturer expectations around eachservice item:1. Minimum Service Level. The minimumlevel of service performance that manufacturersare willing to accept from ANYmajor regulatory agency.2. Desired Service Level. The level ofservice that a regulatory agency shoulddeliver to manufacturers.Data CollectionA list of potential survey participants wascompiled by PQP Staff using internalrecords. The list included regulatoryaffairs professionals (assessment ofproduct dossiers) and quality assuranceprofessionals (on-site inspections) whohad participated in WHO prequalificationof medicines during the period 2006 –2010. Individuals on the contact listrepresented manufacturers of bothbranded and generic pharmaceuticalmedicines who have had a medicinalproduct or products prequalified by WHO.After cleaning and validation, the initial listof 75 contacts was revised to a final list of62 prospective survey respondents. Allcontacts on the final list received an e-mail invitation from Interclarity Researchon behalf of WHO. Each e-mail includedan embedded link to the survey questionnaireon a secure web site. A total of 41completed surveys was collected: 18responses from regulatory affairs professionalsand 23 responses from qualityassurance professionals.Key Findings• Both PQP assessors and inspectors aremeeting or exceeding manufacturerexpectations for service delivery.• The structure of PQP generally deliverslevels of service at, or above, thoseexpected by manufacturers. However,the service process is falling short ofmanufacturer expectations with respectto:- Review/reply time for product dossiers.- Opportunities for in-person communicationduring the assessment process.- Question/problem resolution duringassessment.- Consistency of membership in the teamof assessors throughout the process.- Local/national representation in on-siteinspection teams,• Most manufacturers view PQP GMPrequirements as more stringent thanthose of the US Food and Drug Administrationor European Medicines Agency.• Reducing the time required to prequalifya product requires a joint effort betweenthe manufacturer and the PQP.296
WHO Drug Information Vol. 24, No. 4, 2010WHO Prequalification ProgrammesConclusionsOverall, the findings from this surveyindicate that pharmaceutical manufacturersconsider PQP to be a well-designed,well-executed programme. PQP assessorsand inspectors are meeting orexceeding manufacturer expectations forservice delivery in the process. However,pharmaceutical manufacturer applicantsplace a premium on feedback, communicationsand problem resolution during theprequalification process – with particularemphasis on the assessment of productdossiers – and these are potential improvementareas in the service design ofPQP.Based on the survey results, WHO is nowworking on improvements to the Programmeand these will be implemented inthe coming year.References1. Parasuraman, A., Valarie A. Zeithaml andLeonard L. Berry. SERVQUAL: A Multiple-Itemscale for measuring customer perceptions ofservice quality. Journal of Retailing,1988;64(1):12–40.2. Bitner, Mary Jo, Bernard H. Booms andMary Stanfield Tetreault. The service encounter:diagnosing favorable and unfavorableincidents. Journal of Marketing,1990:54:71–84.3. Hayes, Bob E. Measuring customer satisfactionand loyalty, Third Edition. ed.Milwaukee, WI, American Society for Quality,2008. Quality Press.4. Zeithaml, Valarie A. and A. Parasuraman.Service Quality, Cambridge, MA, 2004.Marketing Science Institute.WHO initiates pilotprequalification of activepharmaceutical ingredientsIn October 2010, the WHO Prequalificationof Medicines Programme (PQP)started to pilot prequalification of selectedactive pharmaceutical ingredients (APIs)for products for treating HIV and relateddiseases, malaria and tuberculosis. Itsfirst “Invitation to Manufacturers of ActivePharmaceutical Ingredients to Submit anExpression of Interest (EOI) for Evaluation”is available at http://who.int/prequal/Globalization of pharmaceutical productionhas led to diversification of APIsources and made verification of APIquality more difficult. WHO’s decision toprequalify APIs responds to the increasingconcern expressed by medicinesregulators regarding API quality, includingthe manner in which APIs are manufactured.PQP already assesses API master files(APIMFs) as part of its evaluation offinished pharmaceutical products (FPPs).This can include inspection of the manufacturingsite to assess compliance withWHO good manufacturing practices(GMP), if risk assessment indicates thatan on-site inspection is necessary. An APIsubmitted for evaluation will undergo bothdossier assessment and inspection of themanufacturing site.Each prequalified API — including detailsof the supplier and manufacturing site(s)— will be added to the WHO List ofPrequalified Active PharmaceuticalIngredients. The List will be of greatinterest to FPP manufacturers seeking toensure the good quality of APIs used inFPP production, and to national medicinesregulatory authorities who wish toverify the standard of APIs that havebeen used to manufacture nationallyregistered medicines.297
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WHO Drug Information Vol. 24, No. 4, 2010

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