Movianto Quality

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Movianto Quality Statement

The European Quality Management System (EQMS) therefore ensures that:

the quality policy is upheld and supported by management and staff at all levels teammateresponsibilitiesanddutiesareclearlyidentified trainings are held on a regular basis sufficientresourcesareprovidedtofacilitatework quality plans are applied in all our projects all appropriate documentation is maintained, controlled and archived periodicauditsandreviewsofoperations,staffandprojectsareundertaken set standards are evaluated to maintain and improve operations (internal & external audits) business continuity plans are available at each site

Quality is essential in every part of our business. We have made product and patient safety the core of our daily business, understanding and sharing the ethics of the healthcare industry. Our documentation is consistent, transparentandvalidatedtoensurethatweconstantlymeetourstandards,fullycomplywithGxPrequirementsand boost improvements.

Since2011theMoviantoGroupisrunningauniform European Quality Management System (EQMS) in accordancewithISO9001:2008,ensuringthesamehighquality standards in all branches. EQMS is structured in a waythatitcaneasilybeexpandedtoadditionalcertifi-cationswithinthehealthcareindustry,ifrequired.Thus, in2013wehavesuccessfullypassedtheISO13485certifi-cation audit for our European Distribution Center in the Netherlands.WiththisnewmilestoneMoviantoproves that it can also manage the special quality norms for the handling of medical devices.

AlloperationswithinMoviantoaremanagedbydedica-tedfull-timequalitymanagersandqualifiedpharmacistsliaisingdirectlywithourclients.Inaddition,standardisedinternal operations ensure that the needs of our clients and their customers are clearly understood and met through an open-communicationenvironment,proactivemanagementand effective monitoring.

Movianto ensures the same high quality standards across alloperationswhileconstantlysharingeachother‘s experiencesinregulargroup-widequalityworkshopsandinternalauditswithover30dedicatedqualityresponsibleteammates.Movianto‘sEQMSisbasedonthecommitmentto discuss, agree and implement best practice on a long termbasis.Inaddition600clientandauthorityauditsperyear ensure consistent high performances.

We strive for a successful business relationship that is based on trust and understand that uniform high quality standardswithinourGrouparethebasisforthe relationship.ThustheQualityDirectorof MoviantoGrouphasadirectreporting line to the CEO.

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Editorial

Movianto Quality At A Glance

Quality at Movianto is based on the close interaction of our quality experts and their clients. Regular surveys, over 600clientandauthorityaudits,annualinternalauditsand

MoviantohasastrongpolicyofinternalauditingwithintheGroup. TheEuropeanQualityTeamensuresthateachbusinessunitisauditedatleastonceayear. Theinternalauditreportsarethebasisforaninternallydevelopedsystemtoscoreandfinallycomparethe complianceinthebusinessesacrosstheGroup. Correctiveandpreventiveactionsintargetedareaswithinthebusinesscaneasilybedefined,whereverrequired. Alsoexternalauditsareperformedonaregularbasisbyauthorities,existingandpotentialclientsaswellas certificationcompanies.

Movianto Audits

ongoingevaluationsessionsarejustafewexampleshowwemakesureourqualitystandardsremainatthehighestlevel.

ISOEN9001:2008 Organisational guidelines Continuous

internal audits Regular supplier audits Ongoing staff training

Access control system Alarmsystem24/7/365 Returns management Batch traceability Frequentqualityworkshops

24/7emergency delivery service Temperature-controlledand

monitored storage Business continuity plans Recall management inreal-time

Warehouse mapping Validatedwarehouse-

management systems SOPs/WI CAPA KPIreporting Bar code based processes

Licenses (storage & distribution of healthcare products, manufacturing, import) Quality experts (consultancy

and product release) GxPcompliance

European Quality Management System

Product Security Patient Safety Operation Standards Regulatory Affairs

Manufacturer Focus Regular survey Continuous exchange Individualsolutions Over600externalaudits/year Group-widestandards&serviceslevels

Internal Processes Evaluation sessions Continuous exchange Ongoingtrainings/workshops Annual internal audits Group-wideorganisationalguidelines

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Movianto Quality KPI‘S

InorderforthebusinesstomeasurethelevelofqualityacrosstheGroup,Moviantohasastandardpackageofkeyperformance indicators that are reported centrally on a monthly basis.

Inventory Accuracy Consistencytowhichthedataintheinventorysystemisinagreementwiththeactualinventoryinthesupplychain Complaints handling Differentiationbetweencomplaintscausewithinthewarehouseandduringtransportation Picking Accuracy Percentageindicatingthenumberofcorrectorderlinesprocessedduringthepickingphase On time delivery Performanceindicatorshowingthenumber/percentageofshipmentsthathavebeendespatchedontime CAPA Management PerformanceindicatorshowingthenumberofoverdueCAPA‘sgroup-wide

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Movianto Business Continuity

Business Continuity Plan (BCP)

Movianto‘sBusinessContinuityPlan(BCP)iswrittendownintheOrganisationalGuidelinesofourEuropeanQualityManagementSystem(EQMS)andisvalidforthewholegroup.

Based on these guidelines we have local BCPs in place and thus we can ensure

that the continuous supply of medicines and devices is given thattheefficacyoftheproductiskeptbymaintaining

the required storage conditions (e.g. chilled, frozen) that security is maintained on our sites (burglaryandfirealarmsystems,CCTV)

Movianto Corporate Site OssO&M-MoviantoNederlandB.V.Keltenweg705342LPOssNetherlandsTel +31(0)412406420Fax +31(0)412406440 Movianto Corporate Site StuttgartMoviantoGmbHDeckerstrasse2770372StuttgartGermanyTel +49(0)711900597900Fax +49(0)711900597910

Movianto Group:

Benelux | CEE | DACH|France|Iberia|Nordic|UK&Ireland

Moviantoreservestherighttomakechangestothisbrochurewithoutpriornotice. Moviantoassumesnoliabilitywhatsoeverinrespectofusemadeoftheinformationinthisbrochure.February2014