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Memorandum of Understanding Between The Office of Regulatory Affairs and The Center for Drug Evaluation and Research

on the Pharmaceutical Inspectorate

FDA oversees the quality of drug productsusing a two-pronged approach involving review of infonnation submittedin applications aswell asinspectionof manufacturing facilities for confonnance to requirements for currentGoodManufacturingPractices (cGMP). Thesetwo programs haveservedthe consumer well by helpingto ensure the quality of drug products availablein the U.S. Now, aswe approach the 25thanniversary of the last major revisionto the drug cGMP regulations, it is time to stepback andevaluate the currencyof theseprogramsand implementnew ones,as appropriate, so that our resources areusedmost effectively and efficiently to address the most significanthealthrisks. To this end,the Office of RegulatoryAffairs andthe Centerfor Drug EvaluationandResearch haveagreed to developa Pharmaceutical Inspectorate (PI) of highly trainedinvestigators whose primary responsibilitywill be conductingdrug quality inspections. The PI will conductinspections ofpham1aceutical facilities asassigned by their District Managers.The goal of the programis to eventuallyhavethe PI inspectthe majority of prescriptiondrug manufacturers andothercomplexor high risk pharmaceutical operations.The PI will alsoconductpreapproval inspections andmay conductor assistin investigations that requiretheir particularexpertise.Attaining this goal will probablyrequirea numberof yearsin building the staff of the PI. [Bioresearch monitoring(BIMO) inspections and training for the BIMO inspections arenot coveredby this MOU.] The principlesagreed upon for the Pharmaceutical Inspectorate areestablished below.

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Membersof the PI will report directly to the District Managers andwill receiveassignments from District management in accordance with the work plan. Investigators who areinterested in becominga memberof the PI will be requiredto obtain andmaintaina Level ill Drug Certificationto serveasmembers of the PI. [NOTE: During the initial development of the PI, not all Level III Drug Certificationcourses may be developed.However,asthesecourses aredeveloped, eachmemberof the PI will be required to completethe course.]

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. The sizeof the PI will be determined based on the inventoryand geographic distributionof
facilities that will be subjectto inspection. The sizeof the PI will be adjustedin conjunction with changes in the workload. The following table outlinesthe estimated phasein period for the PI based on currentworkload andtraining capacity. Anticipated Namber of CSOsto be Added Every Ye8r_FY 2004 FY 2005 FY 2006 FY 2007 TOTAL HumanDrogs 25 10 10 5 SO

Overall, the PI will spenda significantportion of their reportable time conductingdrug quality inspections of domesticand foreign facilities. Collectively,we anticipatethat the PI will spend80% of their reportable time conductingdrug quality inspections andrelated activities. In orderto fulfill requirements andmaintaintheir statusasLevel ill Drug Investigators under the certificationprogram,members of the PI will be authorized andencouraged to participate in professional activities that maintain,broaden, or enhance their knowledgein the areaof certification.
Members of the PI will continue to participate in additional activities which further their expertise in the area of drug quality inspection. This may include activities related to the development and implementation of formal training programs for Agency personnel.industry, and state/localofficials, or the developmentand/or evaluation of the programs, policies, or proceduresin their areaof expertise,including serving as auditors for the Level II or ill Drug Certification programs. The extent and balanceof theseadditional activities will be determined by District Management

Selectionof the Phannaceuticallnspectorate



An individual interested in becominga memberof the PI will submittheir nameto their supervisor for consideration. The initial nominationof an individual for the PI will thencomefrom the District with concurrence throughthe management structurecurrentlyin place. The Level III Drug InvestigatorCertificationBoard will review certificationpackages and selectcandidates for Level III Drug Certificationandmembership into the PI. The following criteria may be usedto selectmembers of the PI: - Candidates shouldhavethe necessary critical thinking andcommunication skills to apply their knowledgeto complexproblemsandto communicate effectively with a variety of stakeholders, - Candidates shouldhaveat least3 yearsexperience in inspecting phannaceutical manufacturing including regulation/inspection of drug facilities, and - Candidates shouldbe certified asLevel II Drug Investigators (asdefinedby the ORA certificationprogram). Onceall Level ill courses havebeendeveloped and the Level ill

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Drug Certificationprogramhasbeenfully Level III Investigators.

mustbe certified as

Continuing Education of the PI The Office of RegulatoryAffairs andthe Centerfor Drug Evaluationarecommittedto providing adequate resources and supportto allow members of the PI to continueto enhance their knowledgein pharmaceutical manufacturing.

Eachmemberof the PI must successfully completecontinuingeducation requirements as definedin the Level III Drug Certificationdocumentto maintaintheir Level III Drug Certification. Continuingeducation may includeattendance at technicalconferences, or successful completionof training courses, or detailsto the Center.

Level III Drug Investigator Certification Board The Level III Drug InvestigatorCertificationBoard will be composed as follows: . 2 Field Investigatorsoperatingat Level III in the areaof certificationbeingreviewed, . 2 Expertsfrom the Centerfor Drug EvaluationandResearch, . 2 Expertsfrom the Centerfor VeterinaryMedicine, . I Division ofField Investigationsexpert(with appropriatetechnicalexpertiseand investigational experience), . I ORA Managerfrom the appropriateField Committeetand . 1 Representative from the Division of HumanResource Development (DHRD), ORA. The Level III Drug InvestigatorCertificationBoardwill be responsible for: . Reviewingpackages and selectingindividualsto participatein the Level III Drug Certificationprogramand PI, . Identifying auditorsfor the Level III Drug Certificationprogram, . Developing,updating,andmaintainingthe curriculum for the Level III Drug Certification programandthe Pharmaceutical Inspectorate, and Reviewingpackages for the recertificationprocess.

Role of the Center The Centerfor Drug Evaluationand Research will: . Providefunding (amountsto be negotiated annuallywith the Office of RegulatoryAffairs) for the development and implementation of training programsidentified in the Level ill Drug Certificationprogramfor the PI, . Providefunding for continuingeducationfor the members of the PI to maintaintheir certification,and . Provideexpertsto serveastrainersandauditorsfor the Level ill Drug Certificationprogram.

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Role of ORA

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Provide funding to develop the training for the Level n Drug Certification, Fonn the Level n and ill Drug Investigator Certification Boards based on membership inclusive of the Centert and Provide experts to serve as trainers and auditors for the Level ill Drug Certification program.

This MOU will be re-evaluated in one yearafter implementation andat regularintervals thereafter.

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