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1 MailThe MCA updating serviceNo. 131 May/June 2002 Control and monitoring of storage and transportationtemperatures Reorganisation of the Inspection Group Future distribution of MAILF urther details of services and prices available from:General Practice ResearchDatabaseWorld s largest database of anonymisedclinical records from general available to pharmaceuticalcompanies under licence with GPRDD ivision include: Direct access to raw data (including up-to-datedata from Vision practices). Subsets of data for single studies. Commissioned studies from the GPRD researchteam, headed by Dr Carlos may be used to support clinical research,epidemiology, drug safety and portfolio website: helpdesk: 020 7273 03831 mail 131 May/June 2002 Items in mail give general guidanceand must not be treated as a completeand authoritative statement of the lawon any particular case.

2 Copies of theMedicines Act and of the Orders andRegulations made under the Actare available from The StationeryOffice 1360-8738 Crown Copyright 2002* Direct dialling is available to all MCAstaff. Please refer to Appendix 7 forMCA contact points. Before eachextension quoted simply dial you do not know who to contactplease telephone 020-7273 is published bimonthly by theMedicines Control Agency (MCA),Department of Health, Market Towers,1 Nine Elms Lane, London SW8 :020-7273 0000*Fax:020-7273 0353 : Ed ScullyDistribution: Ronke OmotayoDesign: Paul HyltonContentsMAIL 131ED SCULLYThe Editor, mail , 10th floor, Market 020-7273 NEWS.

3 2 Manufacturing and wholesaling .. 6 General issues .. 7 PUBLICATIONS ..8 FORTHCOMING MCA SYMPOSIA ..9 APPENDICES ..13 Welcome to mail 131. In this issue we are pleasedto have several contributions from our Inspectionand Enforcement Division, and feature a lead articleby John Taylor summarising the latest guidance on the controland monitoring of storage and transportation have further news items from the section on GoodDistribution Practice (GDP) inspections and Good LaboratoryPractice concerning bioequivalence trials. A new edition ofthe Orange Guide , Rules and guidance for pharmaceuticalmanufacturers and distributors is due to be published verysoon and we give details of the revised publication.

4 We alsogive details of the reorganisation of our Inspection items include information for those submitting variationapplications and news on the MCA s survey of thepharmaceutical industry concerning our standard of , mail has for a number of years been distributed freeof charge to licence holders and other eligible , mail is now available on publication on the MCAwebsite at and, due to the high costsof printing and distribution, we have reluctantly decided tocease free circulation of paper copies. If you are in receipt ofa free copy and wish to continue to receive mail , full detailsof how to subscribe can be found on page six, and on theinsert with this 131 May/June 20022 MCA NEWSMCAI ntroductionEU requirements and guidelines on GoodDistribution Practice require distributors to ensurethat storage conditions are observed at alltimes, including duringtransportation.

5 What followsgives guidance on how thismay be storageMany medicinalproducts require storage atcontrolled low temperature,including those productssuch as vaccines andinsulins and products ofbiotechnology that must alsobe protected from freezingwhich could cause them to temperature in small refrigerators used tostore medicines should be measured continuouslyand the maximum and minimum temperaturesrecorded daily. Sufficient space should bemaintained to permit adequate air circulation. If therefrigerator is filled to capacity the effect ontemperature distribution should be used for vaccines and other sensitiveproducts should be capable of maintaining thetemperature between 2 C and 8 C with the minimumof intervention.

6 Temperature monitoring of theseshould be by electronic thermometer, withan accuracy of + C, which should be readablefrom outside the unit. Refrigerators should not besited in an environment where extremes oftemperature ( <10 C or >32 C) will affect and monitoring of storage andtransportation temperaturesFOLLOWING discussions between the MCA and representatives of UK organisations whodistribute medicinal products on how the EU recommendations on the control and monitoringof storage and transportation temperatures of medicinal products may be met, the MCA hasdeveloped guidance in consultation with those representatives.

7 This was published in ThePharmaceutical Journal in July 2001 . A summary of this guidance is given commercial refrigerators and walk-incold rooms should be monitored with an electronictemperature-recording device that measures loadtemperature in one or more locations, depending onthe size of the unit. Portabledata-loggers that can bedown-loaded onto a computermay be used instead of a fixeddevice. Records should bechecked daily. Internal airtemperature distributionshould be mapped oninstallation in the empty andfull state and annuallythereafter under conditions ofnormal use.

8 Products shouldnot be stored in areas shownby temperature mapping topresent a risk ( in theairflow from the refrigeration unit). Condensate fromchillers should not be collected inside the alarms should be fitted to largeand walk-in units and those smaller units used tostore products at risk from room temperature storageThe simplest monitoring would be with a placed at a strategic location and read,recorded and reset at least weekly, more frequentlyduring periods of exceptionally hot or cold the exception of very small stores, temperaturesshould be recorded at low and high temperature recording is recommended Taylor J.

9 Recommendations on the control and monitoring ofstorage and transportation temperatures of medicinal Pharmaceutical Journal, 28 July 2001, Volume 267, requirements andguidelines on GoodDistribution Practicerequire distributors toensure that storageconditions are observed atall times, including duringtransportationContinued on page 3 Manufacturing and wholesaling3 mail 131 May/June 2002 MCA NEWSfor large warehouses. Self-contained storage areaswithin warehouses, ( CD store, flammables store)should be included in temperature warehouses should be temperature mappedto determine the temperature distribution underextremes of external temperature.

10 mapping should berepeated every two to three years and after anysignificant modification to the premises, stock layout,or heating system. Medicines should not be stored inareas shown by temperature mapping or otherconsideration to be unsuitable, at high level inpoorly insulated stores, or next to of cold-chain route and time of transportation, the localseasonal temperatures and the nature of the loadshould all be considered when arranging cold-chaindistribution. For small volumes of cold-chain goodsinsulated containers may be used, in which case itis vital that products damaged by freezing areprevented from coming into direct contact with icepacks at sub-zero volumes of cold-chain goods shouldbe shipped in refrigerated transport, particularly iftransit times may be prolonged.