TRS_917_annex5

© World Health OrganizationWHO Technical Report Series, No. 917, 2003Annex 5Guidelines for preparing a laboratoryinformation fileA laboratory information file (LIF) is a document prepared by thelaboratory. It contains specific and factual information about the operations carried out at the named site and any closely integrated operations of the laboratory. If only some of the operations are car-ried out on the site, the LIF need describe only those operations, e.g.sampling, chemical analysis or stability testing. The LIF does not include information specific to environmental management, occupa-tional health and safety management, financial management or risk management.A LIF should be succinct and, if possible, should not exceed 25 A4pages.The laboratory should give a short description of its activities under each of the following headings. Where appropriate, supportive docu-mentation should be appended.1.General information1.1Brief information on the laboratory (including name, address andcontact details).1.2Summary of laboratory activities (including those listed below).Activity Performed by Contracted to:laboratory(give name and address)itself (mark X)Conventionalchemical analysisInstrumentalanalysisMicrobiologicalanalysisBiological testingStability testing891.3Any other activities carried out on site. In addition, state therelation (if any) to a manufacturing site.1.4Short description of the quality management system of the labo-ratory (including reference to the existence or not of a quality manual). (Include reference here regarding certification e.g. ISO 17025.)2.Documentation and quality assurance systems2.1Brief description of the procedures for the preparation, revisionand distribution of necessary documentation for specifications, stan-dard test procedures, analyst workbooks or worksheets.2.2Brief description of any other documentation related to producttesting, including reports, records, arrangements for the handling of results (including laboratory information management systems (LIMS) where used).2.3Procedures for release of certificates and analytical reports, stan-dard operating procedures, etc.2.4Brief description of general policy for validation of analyticalmethods.3.Personnel3.1Number of employees engaged in the following activities:Activity NumberSupervisorsAnalystsTechniciansMicrobiologistsOtherTotal:3.2Organization chart showing the arrangements, responsibilitiesand reporting lines in the laboratory.3.3Qualifications, experience and responsibilities of key personnel.3.4Outline of arrangements for basic and in-service training and howrecords are maintained.904.Handling of samples4.1Brief description of general policy for sampling and handling ofsamples.4.2Brief description of the procedures followed. Where possible,flow sheets and charts describing important steps, pooling of samples, storage, work allocation in the laboratory and related aspects should be supplied.5.Materials5.1Brief description of general policy for purchasing and handling ofmaterials including chemicals and reagents, and handling of waste.5.2Brief description of the arrangements for the storage of materialsincluding retention samples, toxic substances and poisons.5.3Brief description of the system for purchasing, preparation, han-dling and testing of reference materials.6.Premises6.1Simple plan or description of the layout of the laboratory areaswith an indication of scale (architectural or engineering drawings not required, but photographs may be submitted if available).6.2Nature of construction and finishes.6.3Brief description of ventilation systems including those for micro-biological testing areas, storage areas, etc. (Include reference to air circulation and to control of temperature and relative humidity.)6.4Brief description of special areas for the handling of highly toxic,hazardous, and sensitizing materials.6.5Description of planned programmes for preventive maintenanceof the premises and the system for recording maintenance activities.Sanitation6.6Brief description of the procedures for cleaning of areas andequipment.Storage6.7Types of products stored on the site, and information about anyspecifically toxic or hazardous substances handled.6.8Short description of the site (size, location, and immediate envi-ronment and other activities conducted on the site).917.1Brief description of main equipment used in the laboratory. At-tach a list of equipment in use, in table form, indicating the equipment and its make and model.7.2Brief description of planned programme for the preventive main-tenance of equipment and the system for recording the maintenance activities.7.3Brief description of qualification (e.g. installation qualification(IQ), operational qualification (OQ) and performance qualification (PQ)) as well as calibration, including the recording system.7.4Brief description of computer system, access to data, data integ-rity management and validation of the computer system.8.Contract operations and activities8.1List of activities contracted out to other laboratories, includingnames, addresses and contact details. Description of the way in which the compliance with standards for activities contracted out is assessed.9.Out-of-specification investigation9.1Brief description of the procedure for recording and investigationof out-of-specification results.10.Self-inspection10.1Brief description of the self-inspection procedure.11.Stability testing (where applicable)11.1Brief description of the stability-testing procedure.11.2Brief description of the conditions under which samples arekept, the arrangements for monitoring and the equipment used.12.Microbiological testing(where applicable)12.1Brief description of the activities for microbiological testing.12.2Brief description of preparation of media and types of mediaused.12.3Brief description of the procedure in place for positive andnegative controls.12.4Brief description of validation policy.12.5Brief description of arrangements for waste disposal.9213.Water system13.1Brief description of the water system in the laboratory.13.2Brief description of arrangements for the sampling and testing ofwater used in the laboratory.93。