MHRA ARCHIEVING

Safeguarding public health

Good Laboratory Practice Guidance on Archiving

Medicines and Healthcare products Regulatory Agency March 2006

CONTENTS FOREWORD ........................................................................................................................................................2 INTRODUCTION................................................................................................................................................2 INTRODUCTION ................................................................................................................................................2 SCOPE ..................................................................................................................................................................2 DEFINITION DEFINI TION OF TERMS TERMS................................................................................................................................3 ................................................................................................................................3 ROL OLES ES & RESPONS RES PONSIB IBILIT ILITIE IES S ..................................................................................................................4 Sponsor..................................................................................................................................................................4 Test fac facililitity y management ............................................... ..................................................................................................... ...................................................................................4 .............................4 Test si site te management .................................................... .......................................................................................................... ....................................................................................4 ..............................4 Stud St udy y Di Direc recto torr ............................................... ..................................................................................................... .......................................................................................................4 .................................................4 Princip Princ ipal al Investi Investigat gator or ...... ............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ..........5 ....5 Archivi Arc hivist st ................................................. ....................................................................................................... ............................................................................................................... ...........................................................5 ..5 MANAGEMENT OF THE ARCHIVES........................................................................................................6 ARCHIVES ........................................................................................................6 Archive Arch ive fac facili ilitities es ...... ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. ............. ............. ............6 .....6 Acces Ac cess s to the archi archive ve ...... ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ........6 .6 Archive Arch ive co condi ndititions ons ....... .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. ............. ............. .............. .............. .......6 6 Archive Arc hive pr proc oced edures ures ............................................... ..................................................................................................... .............................................................................................7 .......................................7 Placement of study materials into the archive............................................................................................7 Placement of non non study study spec specifi ific c materials materials into the the archi archive ve ....... ............. ............. .............. .............. ............. ............. .............. .............. ............7 .....7 Retrieval..................................................................................................................................................................7 Transf ransfers ers ................................................ ...................................................................................................... .............................................................................................................. ..........................................................8 ..8 ELECTRONIC RECORDS ..............................................................................................................................9 Decision to retain records electronically......................................................................................................9 Approaches to archiving of electronic records..........................................................................................9 Maintenance and preservation of electronic records............................................................................10 Acces Ac cess s and sec securit urity y ....... .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. ............. ............. ........10 .10 RETENTION OF MATERIALS ....................................................................................................................11 Retention period................................................................................................................................................11 Business Bus iness co conti ntinuit nuity y and Dis Disaster aster rec recovery overy ...... ............. .............. .............. ............. ............. .............. .............. ............. ............. .............. .............. .............. ............. ......1 12 QUALITY ASSURANCE ..............................................................................................................................12 CONTRACT ARCHIVE SERVICES ..........................................................................................................13 CLOSURE OF AN ARCHIVE......................................................................................................................14 ARCHIVE......................................................................................................................14 DOCUMENTATION ........................................................................................................................................15 OTHER OT HER USE USEFUL FUL DOCUM DOCUMENTS/ ENTS/ REFER REFERENCES ENCES............................................................................16 ............................................................................16

GUIDANCE ON ARCHIVING

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FOREWORD The need for secure retention of materials from completed studies, and the retention of supporting test facility records, is one of the fundamental requirements of the principles of Good Laboratory Practice (GLP). The UK Good Laboratory Practice Monitoring Authority (GLPMA) invited the Scientific Archivists Group (SAG) and the British Association of Research Quality Assurance Assura nce (BARQA) (BARQ A) to participate in a working group to deve develop lop guidan g uidance ce tha t hatt could c ould be used used to assist in the interpretation and and application of the GLP principles. principl es. This document was produced by that working group drawing upon the collective experience of the organisations that they represented, and by reference to existing docum doc uments ents on the subject. subject . The guidance and advice advice contained contained within within this document is consistent with the requirements of the UK GLP Regulations

INTRODUCTION The archiving of study materials and test facility records is an important part of compliance compli ance with the the principles principles of GLP G LP.. The maintena maintenance nce of these these materials materials is the only means that can be used to reconstruct the study, enabling the information contained in the final report to be verified. The guidance contained in this document will assist in conforming to the requirements of the United Kingdom Good Laboratory Practice Regulations (Statutory Instrument 1999 No. 3106) as amended by Statutory Instrument 2004 No. 994, “The Good Laboratory La boratory Practic Practice e (Codification (Cod ification Amendme Amendments nts etc.) etc .) Regulations Regulations 2004 20 04”” as they relate relate to archiving. These regulations regulations implement the requirements requirements of European European Directives Direct ives (2004/9/EC and 2004/10/EC) and are consistent with the OECD Principles of Good La Labora boratory tory Pra Practic ctice e (ENV/ (ENV/ MC/ MC/CH CHEM(98)17). EM(98)17).

SCOPE This document is primarily intended for use by test facilities that are required to operate in compliance with the principles of GLP, and for organisations that provide contract cont ract archive services to such test facilities. facilities. Although aimed aimed at G LP regulated organisations, the guidance and advice contained within this document might be of assistance to organisations that retain records and materials from other types of regulatory work, for example Good Clinical Practice. Individual organisations must ensure that they evaluate any applicable regulatory requirements requiremen ts against against their business needs. Cert Certain ain aspect aspects s of archive archive const construct ruction ion and operation may have implications for compliance with building regulations or Health & Safety legislation. legislation. Guidance on these, and other such aspec aspects, ts, is outside the scope of this document.

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GOOD LABORATORY PRACTICE

DEFINITION OF TERMS Archives: The facilities and supporting resources necessary for the secure retention and maintenance of materials accumulated by an organisation in the conduct of regulatory studies. Computer support staff: Designated personnel given responsibility for providing technical support to other staff using a computerised system. Electronic record: Information recorded in electronic form that requires a computerised system to access or process it. Material(s): A collect collective ive term given to all items which need need to to be retain retained ed for regulatory purposes. This includes, but is not limited limited to; raw data, data, specimens, test item it ems s and and non study specific records. records. This includes record records s main maintained tained in electronic form. Metadata: Information associated with data that provides context and understanding, i.e. data about about data. Most commonly this is data that describes describes the struc structure, ture, data data elements, inter-relationships and other characteristics of electronic records. Migration: The transfer of data from a source format or system to a target format or system. Record: Recorded information, regardless of storage medium or characteristics, that is evidence of an activity or an event. Record retention schedule: A list of record types with the required storage conditions and defined retention periods. Refreshment: Procedures to maintain the physical viability and continued readability of records, particularly particularly those stored electronically electronic ally.. These ma may y includ include e cop copying ying to fresh media or periodically running tapes to prevent sticking. Rete etention ntion period: The length of time for which materials should be kept Storage media: The different materials on which information may be recorded. Examples include paper, photographic film, magnetic media, microforms and optical devices.


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ROLES & RESPONSIBILITIES Sponsor The sponsor is responsible for ensuring that material required to support their regulatory studies is retained and maintained in conditions that ensure its integrity and continued cont inued acc access. ess. St Storage orage should be in archives archives that that meet meet the requirements requirements of the GLP principles. It is also the sponsor’s responsibility to ensure that such material is retained for as long as it may be required by any regulatory authority. The sponsor is directly responsible for any materials that are in their custody. The sponsor should maintain maintain contact cont act with with the faci facilit lities ies that archive archive its materials. This is of particular importance when study materials have been archived at more than one location, e.g. as a result of a multi-site study. Test facility management Test facility facil ity managem management ent is responsible responsib le for the provision of archive facil faciliti ities. es. Test facility management should appoint an individual who is responsible for the day to day management and operation of the archives, commonly called the “Archivist”. This appointment should be documented and authorised by management. Consideration should be given to who would assume this responsibility in the absence of that person. Test facility management is responsible for ensuring that any non study specific materials needed to support the GLP compliance status of the test facility, or of studies studi es conducted conducted therein, therein, are archive archived. d. Such records record s may may incl include ude but are not limited to: equipment maintenance records, personnel records, historical SOPs etc. Removal of material from the archives should be authorised by test facility management. Test site management Test site management has the same responsibilities as test facility management with regards to archive facilities and procedures at their premises. Study Director The study director is responsible for ensuring that, on completion of a study, all study specific materials are archived.

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Principal Investigator A principal investigator is responsible for ensuring that study specific materials for which they were responsible have been sent to the study director, or transferred to an agreed archive location In this document, the term “Archivist” is used to identify the individual appointed by test facility management to assume responsibility for day to day management of the archives.

Archivist The archivist should be independent of any materials that are passed into their care, i.e. they should not be responsible for archiving any study materials produced by them, as there could be a potential conflict conflic t of interest. Where possibl possible e the archiv archivist ist should be independent of the line management responsible for the conduct of the studies. The archivist is responsible for the day to day management of the archive facilities in accordance with established company policies, standard operating procedures and the principles of GLP. In particular the archivist is responsible for: • Controlling access to the archive • Ensuring that orderly storage and retrieval of materials is facilitated (e.g. by means of indexing) • Ensuring that movement of material in and out of the archives is properly controlled and documented. • Ensuring that material submitted for archiving corresponds to that described in chain of custody documentation. In larger organisations where many studies are conducted, there may be a need for several seve ral staff to effectively effec tively undert undertake ake archiving of the study materials materials produced. produc ed. These staff st aff should should work under under the supervision supervision of the designated archivist. archivist. Also, in cert certain ain circumstances it may be necessary to designate other persons to undertake particular archiving tasks on behalf of the archivist, e.g. to manage electronic data or to work at remote locations.


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MANAGEMENT OF THE ARCHIVES Archive facilities The archive facility should be suitably designed and constructed to accommodate the archived materials. materials. This may may be a build building ing or a room, a fire-proof safe or lockable cabinet. The archive facility must be secure to prevent unauthorised access to the retained materials, e.g. by the use of locks or electronic entry systems. Buildings or rooms should be designed to withstand the elements of local weather, and consideration may need to be given to specific local conditions such as a risk of flooding. flood ing. Its desig design n should protect protect the cont contents ents from untimely deterio deterioration. ration. Water pipes in the archive areas should be avoided as there is a risk of leakage and subsequent water w ater damage, damage, for example example the siting sit ing of archives in basements basements is not ideal id eal due to the risk of flooding. flooding. The use use of naked naked flames, flames, or other open heat heat sources, sourc es, within wit hin or around around the archives should be prohibited. prohibit ed. It is recommended recommended that an an automated fire detection system is installed, and management may also consider an appropriate fire suppression system. The facility should prevent the entry of rodent and insect pests as any infestation may cause irretrievable damage damage to the archived archived materials. materials. If there is a risk that pests pests could gain access to the archives, a pest control programme should be implemented. Access to the archive Access to archive storage areas should be controlled and restricted to the archivist and any designated archive st staff. aff. Should it be necessary for other personnel to access the archive storage areas for any reason, they should normally be accompanied by the archivist, or a member of the archive staff at all times. A record of such visits should be retained; this record should include the identity of the visitor, the identity of the attending archive staff, the reason for the visit and the date and duration of the visit. Special arrangements may need to be made in exceptional circumstances, e.g. “out of hours” security patrols. Archive conditions Storage conditions should not adversely affect the integrity of retained material. Extremes in variation of temperature and humidity may contribute to the deterioration of the materials being archived, so it is important to protect retained materials from frequent fluctuations fluct uations in temperature and/o and/orr humidity. humidity. The inst installation allation of systems systems to control and monitor environmental conditions may be necessary. Test facility management should define acceptable storage conditions for the different types of retained materials. Guidance on storage conditions may be found in the reference documents identified at the end of this document.

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Special storage conditions may be required for particular materials, e.g. material required to be stored frozen, refrigerated, desiccated etc., or freedom from dust or magnetic ma gnetic interference in the case of elect electronic ronic media. The need for spec special ial storage conditions should be defined in relevant SOPs and the record retention schedule. When particular storage conditions have been defined, environmental monitoring procedures should be implemented to confirm that these conditions are being maintained. In the case of critical materials, the need for continuous (automated) monitoring systems, which also activate alarms in the event of defined conditions being exceeded exceeded should be consi considered. dered. There should be defined procedures procedures for investigating and dealing with out of specification events. Archive procedures Placement of study materials into the archive The study director retains responsibility for the security of study materials until they are acc accepted epted into into the archives. archives. During the conduct conduct of some study types, a large amount of materials will be produced before completion of the study and formal archiving of the study specific specific materials. materials. In these situations the provision of secure storage facilit facilities ies for study specific materials materials should should be considered. Such facilities are commonly termed “pre-archives”. The study director should identify all materials that are to be archived from each study. The study director should ensure that these materials are transferred to the archives as soon as possible after issue of the final report. Some study materials may be submitted to the archives by persons other than the study director, e.g. data sent from a principal investigator, histopathology specimens submitted subm itted by the pathologist. pathologist. In these situations the study director should be informed when these materials have been archived. Archives staff should verify that the materials received correspond with the information provided. There should be a doc docum umented ented acceptance accept ance of the study package by the archives staff. Placement of non study specific materials into the archive Managem Man agement ent should ensure that these materials, materials, e.g. equipment records, record s, staff training records, record s, organisati organisation on charts charts etc., etc ., are archived on a regular basis. basis. Procedures for archiving of these materials should be similar to those employed for study materials. Retrieval Materials that have been archived may, on occasion, need to be retrieved, e.g. for regulatory inspection. inspect ion. The number number of retrievals retrievals should be be minimised; minimised; the archivist may may


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provide copies of the requested information rather than releasing the raw data, or the data may be reviewed in the presence of the archivist or designated archives staff. Once material has been archived, test facility management assumes responsibility for its retention. Therefore, the release release of material from the archive, for whatev w hatever er reason, should be documented and approved by management. Procedures for the removal of materials should be documented, and should include: • The reasons for which materials may be removed from the archives (often referred to as loans). • The timeframe timeframe within wit hin which the t he removed removed (loaned) material material should be b e returned to the archive. • How the archivist identifies any materials that have not been returned within the specified timeframe. • Mechan Mechanisms isms to ensure the return of these t hese materials materials by the person person to whom they had had been loaned. On return to the archive, the materials being returned should be checked to confirm that they correspond correspond to the the materials materials loaned. loaned. Mana Managemen gementt should be be informed of any any discrepancies. disc repancies. The archivist archivist should maintain appr appropriate opriate records records of all material material loans loans and subsequent returns. Transfers On occasion it may be necessary to transfer archived materials from one location to another.. The archivist another archivist transferring t ransferring the material material should ensure that clear clear confirmation of intent is received from the owner of the archived materials (usually the sponsor) before any transfer occurs. This should include details of the materials to be transferred, the contact details/address of the receiving facility, and the means of transfer between locations. The materials to be transferred should be clearly described in appropriate chain of custody documentation prepared by the archivist. The transportation of the material, and associated paperwork, between the two locations should be undertaken in such a way as to minimise the risk of loss or damage of the materials. The recipient of the transferred materials should check that they correspond with the associated chain of custody documentation as, once accepted, they become responsible for ensuring that the data is maintained and preserved appropriately. Copies of the chain of custody documentation should be retained by all parties involved in the transfer.

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ELECTRONIC RECORDS Requirements for the archiving of electronic records are the same as those for other record types, t ypes, but there there are some addit additional ional features, features, which are addressed below. It is therefore important that management should establish a policy for the archiving of electronic media in a secure GLP environment. Decision to retain records electronically The decision to retain data or records in electronic form has important implications. The long term retention of electronic elec tronic data may may influence the choice choice of storage medium since deterioration of storage media can lead to permanent loss of data or records. Computer technology becomes rapidly obsolescent, and devices capable of reading storage media in common use today may not be available in the future. Approaches to archiving of electronic records Intermediate storage media Raw data is copied from a computerised system onto an intermediate storage medium, e.g. magnetic tape, floppy disk, CD or optical disk that can be placed in a physical archive. archive. Archive proc procedures edures should include the consid consideration eration of addi additio tional nal controls cont rols for the refreshme refreshment nt of these data. Co Consideration nsideration must must be given to future access to t o the data or records records stored st ored on these media. media. There may may be a need need for special special storage conditions, e.g. protection from magnetic fields. Defined archive area on a computerised system Data files may be moved from the production part of a computerised system to a discrete, disc rete, secure archive archive area area on the same same computer system. Data files must must be “locked” such such that they can no longer be altered or deleted. Records and and data archived in this way must be under the control of a designated archivist, and be subject to equivalent equivalent controls to those applied applied to other record types. “ Locke Locked” d” files should only be unlocked, or returned to the production part of the system, by the designated archivist according to documented procedures. Dedicated electronic archive system Raw data are migrated from the computer system that captured or manipulated them into a separate dedic dedicated ated elect electronic ronic archive system. All data associated with wit h the reconstruct reconst ruction ion of the study needs needs to be migrated. migrated. This includes, but is not limited to raw data, meta data, audit trails and associated features that allow access to the data in the future. The electronic archive system should be owned by the designated archivist, with technical technic al assist assistance ance provided by computer support support staff as necessary necessary.. These st staff aff must follow procedures agreed with the designated archivist.


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Maintenance and preservation of electronic records Electronic records are at risk without a preservation process to ensure that there is access acc ess to these record records s in the future. Procedures should be in place to ensure that essential information remains complete and retrievable throughout the specified retention period. If the record medium requires processing in order to render the retained records into a readable format, then the continued availability of appropriate equipment should be ensured. ensured. If ava availabili ilability ty can not be ensured, ensured, the possibility possibility of migrating data from one medium to another should be considered. If data migration is necessary, the process of data migration must be fully documented, and validated, to ensure complete and accurate migration of the original data before they are lost or destroyed. Access and security There should be security measures in place to ensure that only authorised personnel can access the electronic archive system, and to enforce restrictions on access levels. These can be both physical physical and and logical. logic al. Phy Physical sical security includes the use of locks/keypads/cards to restrict entry to the area in which the archive system can be accessed. Logical security security is software soft ware based, based, e.g. passwords passwords that are designed to limit access to particular record records. s. Although elect electronic ronic data are are under under the control of the designated archivist, computer support staff may need to help with the refreshment of data on different storage media and with the future readability of the data. The controls necessary necessary to restrict restric t access acc ess to electronic elect ronic records will usually be different from those applied to other other record types. t ypes. Sinc Since e many many elect electronic ronic storage storage media media can be re-used (e.g. overwritten) controls should be implemented to ensure that records can not not be altered altered or deleted without appropriate appropri ate authorisation. If record records s can be altered or deleted there must be a full audit trail of all such changes.

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RETENTION OF MATERIALS Retention period Materials should be retained for the period(s) specified in other applicable legislation or guidance. If specific retention periods are not not defined, defined, then then test facility facility man managem agement ent should draw up a record retention schedule for the different different types of retaine ret ained d materials. materials. This schedule should define each type of material, the storage conditions and periods of storage. The retenti retention on period set should take acc account ount of any any legal, regulatory, regulatory, operational, historical or fiscal requirements that apply to the organisation. The retention period is usually a fixed period from the time that the record was created, but may be a fixed period following a defined event, e.g. “after completion of the study”; “after termination of employment”. When determining appropriate retention periods, the following factors should be considered: • The possible risks to the organisation should the material not be available for exam ex amination ination at any any time in the future. St Study udy data and and supporting support ing records records should be retained for as long as there is a likelihood that they will need to be referred to for regulatory purposes. • Supporting material (e.g. staff training records, equipment calibration records etc.) that would be required to confirm the validity of study material should be kept for as long as the study material that they support. • Specimens and samples need not be retained, for regulatory purposes, for periods of time beyond which no useful information could be derived from them, e.g. retention of test materials that are known to have only limited stability. • The possibility of migrating data from one medium to another could be considered, e.g. bulky paper data could be copied onto microfilm or scanned into electronic form etc. If data is migrated from one medium to another, the potential potential problem probl ems s of future readability will need to be considered.


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Business continuity and Disaster recovery It is important that test facilities have clear documented procedures that detail the steps to be taken to minimise damage to archived materials caused by significant adverse adve rse events. events. The types of event event to be considered in the plan should be determined by an assessmen assessmentt of the risks that t hat the archive may may be exposed exposed to. These are likely to be dependant dependant on the archive’s archive’s location location and and environmen environment. t. Risks to be considered should include fire, flood, pest infestation, and structural damage due to, e.g. subsidence and forced entry of the archive by unauthorised persons. The plan should cover recovery and/or restoration of lost or damaged materials, and should re-establish re-establish the security security of damaged damaged and and undama undamaged ged material. material. It should include useful contacts, the whereabouts of necessary equipment, and the records that should should be made. made. It should should tak t ake e into acc account ount possible roles of the em emergency ergency services, define who may access the archive in an emergency, and identify that access to the archive by employees will be denied while there is a risk to their health and safety. It may may be useful useful to establish est ablish contacts contact s with wit h approp appropriate riate specialist organisations that can provide a service to recover and/or restore damaged archived materials. It may be appropriate for business continuity plans to be tested periodically in a simulation simula tion ex exercise. ercise.

QUALITY ASSURANCE The quality assurance programme for the test facility should include the archive facilities and their operation; routine QA inspections of the archive facility and its operation must be conducted. It is not uncommon for management of the archive function to rest with the QA manager ma nager,, and and QA Q A staff staff may may be designated designated as archivists archivists.. In these situations there is a possible possi ble conflict confli ct of interest. int erest. This can be avoided avoided by the use use of an an ex external QA consultant or the use of other suitably trained/experienced staff from outside of the archives/QA archives/Q A department. department. Alternatively Alternatively,, proc procedures edures could be established that allow non-archivist QA officers to perform the inspections/audits and report any findings directly to management, thus by-passing the usual reporting lines that could give rise to a conflict of interest.

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CONTRACT ARCHIVE SERVICES The GLP principles require that a test facility has an archive to provide secure storage of data, record records s and and specime specimens. ns. This will usually consi consist st of archive facili facilities ties within wit hin the test facility itself, but the use of contract archive facilities is not precluded (refer to guidance contained within the “Guide to UK GLP Regulations”). If contract archive facilities are used, the general guidance contained within this document should apply, and the following should also be considered. Service Level Agreements There should be a formal, documented, agreement between the contract archive and test facility/test facilit y/test site mana managem gement ent that details the t he level level and and conditions c onditions of service to be be provided. This agreement should define the location of the archive facilities that will be used, and cover the transportation of material to the archive (including any necessary environmental conditions to be maintained during transport), chain of custody, access to stored material by the contract archive, storage conditions, period of storage, method of retrieval/access and method of return/disposal. The contract archive organisation should follow relevant SOPs, either its own, or those provided by test facilit facility y ma managem nagement. ent. This should be specified specif ied in the agreemen agreement. t. Access arrangements Procedures should define how, and when, stored material can be accessed by representatives of the test facility facilit y. Any such acc access ess should should be documented. Conditions of storage The conditions of storage within the contract archive facility should be the same as those expected of a test facility archive which is operated in compliance with the GLP principles. This will include the management appointment of an archivist, written and approved SOPs describing their activities and the provision of suitable storage areas to prevent deterioration or loss of stored materials. Audits Representatives of Quality Assurance from the test facility/study sponsor must inspect the contract archive facility periodically to ensure that the conditions of the service level agreemen agreementt are being met. The systems systems and and proced procedures ures operated by the contract archive facility should comply with their own SOPs, the GLP principles and any other applicable regulatory requirement.


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CLOSURE OF AN ARCHIVE If a test facility closes down, the fate of any archived materials needs to be determined. Materials should should be retained in secure (GLP standa st andard) rd) archives in case the records were to be the subject of a formal regulatory study audit in the future. When the test facility that is closing down is part of a larger organisation, there is the possibility that retained materials could be transferred to other (GLP standard) archives wit within hin that organisation. Any such transfer of materials materials should be carried out underr closely unde c losely controlled conditions c onditions and appropriate records ma maintaine intained. d. If the test facility that is closing down is a contract research organisation, in the first instance they should contact the sponsors of the work that they have undertaken and ask for advice on the disp disposit osition ion of any any ret retained materials. materials. Possible scenarios are: • The The sponsor may request that t hat study study materials are returned to them. them. To ensure the validity of these study data it might also be necessary for the sponsor to obtain copies of relevant non-study specific material such as equipment calibration records etc. • The sponsor may request that their data be transferred to another storage location loc ation specified specifi ed by them. Again, it might be necessary for them to obtain obt ain copies of relevant non-study specific material that would be necessary to support the study data. • The sponsor may instruct the test facility to destroy some, or all of their data. In each case, the sponsor should ensure that there are complete and accurate records of the final disposition of all data, records and specimens from GLP compliant studies. studi es. Consid Consideration eration should also also be given to the fate of non study specific specific supporting records. In any circumstances, test facilities in the United Kingdom may contact the GLPMA for advice and guidance.

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DOCUMENTATION Management approved SOPs that describe archiving procedures should be maintained. SOPs will include, but not necessarily be limited to, the following: • Definition and description of the facilities which constitute the archive. • The conditions under which material is stored and any monitoring of those conditions. • Procedures to ensure the integrity of the archive storage facilities and material stored.. This might stored might include include pest control, control, environm environmental ental monitori monitoring ng and and checks on the conditions of material stored. • Procedures for the receipt and checking of material to be archived. • Maintenance of archived material, including the migration of electronic data. • Indexing of archived material to ensure timely retrieval. • Retrieval of archived material for temporary loan (including permissible loan periods), permanent transfer, authorised destruction or further examination. • Return of loaned materials into the archive. • Security of the archive facility and the material retained, including access controls. Other documentation to be retained will include: • Records of appointment of the archivist and archives staff. • The record retention schedule. • The business continuity plan. • Records of materials accepted into the archives. • Third party agreements (where applicable).


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OTH ER US USEFUL EFUL DOCUM DOCUMENT ENTS/ S/ REF REFEREN ERENCES CES References Guide to UK G LP Re Regulations gulations 19 199 9 9, MH MHRA RA GAMP 4 Recomm Recommended ended Environm Environmental ental Conditions Conditions for St Storing oring Various Various Recordi Recording ng Media Media Recommended Environmental Conditions for Storing Various Recording Media — www.michigan.gov European Commission Detailed Guidelines on the Trial Master file and Archiving ENTR/ ENT R/F F/2 D2002 Consultative Committee on Space Data Systems —The Blue Book (CCSDS 650.0-B-1) the Reference Model for an Open Archival Information System (OAIS) http://ssdoo.gsfc.nasa.gov/nost/isoas/ref_model.html. This Recommendation has been adopted as ISO14721:2002. Consultative Committee on Space Data Systems —The Red Book (CCSDS 651.0-R-1) Guidance to Industry – Archiving Submissions in Electronic Format —NDAs www.fda.gov/cder/guidance/index.htm FDA CFR 21 Part 11 B S 545 54 5 4:2 4:200 000 0 Storage and and exhibition exhibition of archiv archival al documen documents, ts, and and DISC PD 0024:2001 guide to its interpretation. ISO 11799: 2003(E) Information and documentation —Document storage requirements for archive and library materials. Good Practice and Compliance for Electronic Records and Signatures. Part 1 Good Electronic Electronic Records Managemen Managementt (GERM). (G ERM). ISPE and and PDA July 20 2002 02 BS ISO 15489-1:2001, Information and documentation Records management (Part 1 General, Part 2 Guidelines)

There is a series of OECD guidance documents on specific aspects of Good Laboratory Practice. These documents may include include additional specific requirements relating to archive archive procedures. These documents may be obtained from OECD, Paris.

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Medicines and Healthcare products Regulatory Agency Markett Towers 1 Nine Elm Marke Elms s Lane Lane London SW SW8 8 5NQ 5N Q T 020 7084 2000 F 02 020 0 708 708 4 23 2353 53 www.m www.mhra hra.gov .gov.u .uk k

MHRA ARCHIEVING

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