MANUAL FOR INSPECTORS MONITORING COMPLIANCE WITH THE PRINCIPLES OF GOOD LABORATORY PRACTICE

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1 MANUAL FOR INSPECTORS MONITORING COMPLIANCE WITH THE PRINCIPLES OF GOOD LABORATORY PRACTICE by the Inspection Procedures Group of the National and Länder Working Party on GLP (since 1997: NLWP on GLP and other QA Systems) 8th edition, August

2 Contents 1. PREPARATION OF AN INSPECTION OR STUDY AUDIT Questions to put to the Test Facility before an inspection Formation of the inspection team Request for documents by the inspection team PRELIMINARY INSPECTION Introductory discussion Brief introductory inspection of rooms Concluding discussion REQUEST FOR DOCUMENTS BETWEEN PRELIMINARY INSPECTION AND INSPECTION (SEE ALSO 1.3) INSPECTION OF A TEST FACILITY OR A TEST SITE Introductory discussion on the way the inspection is to be conducted Discussion of documents Organisation Personnel Rooms/installations Standard Operating Procedures Miscellaneous Quality Assurance Quality Assurance programme Quality Assurance activity Quality Assurance and animal keeping Quality Assurance and field studies

3 Quality Assurance and data processing (DP) Quality Assurance and instrumental analysis or collection of physical-chemical data Inspection Preliminary remark Rooms/installations Questioning of personnel: Standard Operating Procedures Apparatus, materials and reagents Studies carried out on animals Studies carried out on microbial, cellular and subcellular test systems Greenhouse and semi-field studies Field studies (see ) Studies in the area of instrumental analysis or collection of physical-chemical data Test and reference items Data processing (see also 4.3.5) Archiving General aspects of archiving Data archive Materials archive Audit of completed studies Selection of studies Preparation for study audits Carrying out the study audit Possibly take a look at particular procedures in a comparable current study Discussion of results of study audit

4 4.7. Concluding discussion Participants Communication of defects found Setting deadline for rectifying defects Announcement of re-inspection in the case of serious defects Binding designation of Test Facility Determination of study categories Vote taken by inspection team INSPECTION REPORT Name and address of TF and all TSs if appropriate Reason for and period of inspection Participants in inspection Study categories Names of structures audited/areas of TF Names of current studies inspected and completed studies audited List of defects found Overall impression of TF Inspection team's vote on granting of certificate Possible annexes to inspection report:

5 Annexes ANNEX 1: ANNEX 2: ANNEX 3: ANNEX 4: ANNEX 5: ANNEX 6: ANNEX 7: STANDARD OPERATING PROCEDURES STUDY PLANS FINAL REPORTS FIELD OF APPLICATION OF GOOD LABORATORY PRACTICE IN GERMANY SHORT-TERM STUDIES STUDY CATEGORIES LITERATURE -5-

6 Abbreviations: GLP TF TS TFM SD PI QA SOP CV Good Laboratory Practice Test Facility Test Site Test Facility Management Study Director Principal Investigator Quality Assurance Standard Operating Procedure Curriculum vitae Note: This manual has been prepared on the basis of the ChemVwV-GLP (Administrative Regulation concerning chemicals - Good Laboratory Practice) and the experience of inspectors in the Inspection Procedures Group of the National and Länder Working Party on GLP (since 1997: NLWP on GLP and other QA Systems). It lays no claim to completeness. The points made here are examples only, to be adapted to the situation at individual TFs. Annexes -6-

7 1. PREPARATION OF AN INSPECTION OR STUDY AUDIT 1.1. Questions to put to the Test Facility before an inspection Type, size of TF (e.g. number of personnel, scope of testing, any sponsors) Nature of studies/study categories (any specification/limitation of study categories), see also explanatory notes in Annex Statement whether inspections are made in accordance with 19a or 19b of the Chemicals Act (GLP as an obligation or legitimate interest) Organisational structure (identification of changes since the last inspection) Find out who is responsible for what in the TF, e.g. TFM, SD, QA, PI if applicable, and who has responsibility for archives, computing and authorising use of the data processing system Ask what are the established competences, terms of contract and modes of behaviour between sponsors and the TF, between this and other TFs, between the TF and its branches/associated TSs and between the TF and outside/independent TSs (subcontractors) For each site ask for the exact name, address (in another Land or abroad?). Does it have its own GLP certificate? Compare answers with the Federal GLP Agency's list of officially inspected TFs or TSs with regard to valid GLP certificates 1.2. Formation of the inspection team At least two inspectors (decide which one is in charge); as a rule with a specialist knowledge of the TF's areas of study In animal experiments: as a rule with a veterinary medical officer participating or a prior check that animal protection regulations are complied with If necessary, participation of one or more experts (confidentiality must be assured and guaranteed in writing; a problem in the case of consultants) If necessary seek administrative assistance if associated TSs, independent TSs or TFs in other Länder are participating. If TFs or TSs abroad are to be involved, contact the Federal GLP Agency 1.3. Request for documents by the inspection team -7-

8 Note from the inspectors to the TF: confidential TF documents are to be marked "sealed, personal" for security reasons when sent to inspectors. (The same applies to postal communications between the inspectors) List of all completed/current/discontinued studies at least since the last inspection (if necessary: studies subject/not subject to GLP Principles), (see also 3.1) Organisation charts (company/glp structure), where appropriate take into account associated TSs or independent TSs List of GLP personnel (company hierarchy, responsibilities, training); where there are changes compared with the last inspection any CVs of new employees Quality Assurance programme List of all Standard Operating Procedures, any copies of the most important SOPs (see Annex 1, Standard Operating Procedures) List of important apparatus Building/site plans ( labelling of GLP areas); for TSs also. 2. PRELIMINARY INSPECTION (Useful and necessary at least as a technical and organisational preparation for first inspections) 2.1. Introductory discussion Participants: inspectors, TFM, SD, QA management, possibly archive manager, PI if applicable Discussion of documents requested, representation rules, responsibilities, range of duties, any amendments called for Confirmation of exact name of TF; any TSs, outsiders (subcontractors) Deciding which areas of the TF are to be inspected 2.2. Brief introductory inspection of rooms 2.3. Concluding discussion -8-

9 Are the conditions right for an inspection? EN-TRA-00 (DE) Set time and scope of inspection (agreement on current studies during inspection, where appropriate decision on inspections of associated TSs or independent TSs) Determination of study categories (type of studies) for the GLP certificate Identification of discussion partners for inspection Provision of an office and if necessary a secretariat (copiers, printers) for the inspectors during inspection Indication of any defects already detected 3. REQUEST FOR DOCUMENTS BETWEEN PRELIMINARY INSPECTION AND INSPECTION (SEE ALSO 1.3) 3.1. Master schedule (complete list of all current, completed and discontinued studies specifying: study code, test item, test system, type of study, SD, start/end/status of study, sponsor), if necessary since the last inspection, confirmation by QA that list is complete 3.2. Specimen study plan, or study plan and final report for one or more studies (see and ) 3.3. Selected SOPs (see also 4.2.4) 4. INSPECTION OF A TEST FACILITY OR A TEST SITE (When inspecting TSs inspect the relevant points in the same way) If no preliminary inspection has been carried out, deal with the points mentioned in section 2 during the inspection itself Introductory discussion on the way the inspection is to be conducted Persons carrying out or who have carried out GLP tasks must if possible be present/reachable (TFM, SD, QA, PI if applicable, archive manager or representative) Accompanying the inspectors through the TF: QA throughout the inspection TFM at least during the introductory discussion and the concluding discussion SD, PI if applicable, archive manager in their respective areas personnel in their respective areas of competence -9-

10 Fixing the schedule for the inspection (take account of studies in progress) Provision of an office for the inspectors, organisation of a secretariat (see also 2.3.5) -10-

11 4.2. Discussion of documents Organisation Organisation chart from GLP point of view (especially independence of individual GLP functions, TFM with written authorisations), procedure and documentation on rules relating to representatives Number of studies subject/not subject to GLP Principles Number of personnel (academic, technical, other), of whom parttime Master schedule for estimating the workload on GLP personnel and on the area in which the TF is being used. Updating and archiving of the master schedule Personnel Qualifications and areas of activity of personnel curriculum vitae education and training (specialist, GLP) task descriptions Health and safety precautions; exclusion of employees whose state of health might adversely affect the study List of names/signatures/initials Rooms/installations Appropriate size, construction, functionality and position on the basis of up-to-date building/site plans (incl. TSs) Standard Operating Procedures Are the study areas sufficiently covered by SOPs in the study categories to be certified? SOP on the form, drafting, amendment, updating, indexing, authorisation, distribution, archiving of SOPs SOPs on the QA programme All SOPs covering more than one study (e.g. receipt of test item, coding of studies, archiving, etc.), see Annex Miscellaneous Animal protection Animal protection officer Veterinary medical officer's certificate of compliance with the animal protection rules Selection of current studies practical sections of which are being examined in the course of the inspection (see also 2.3.2) Selection of completed studies for study audits, except where already specified in the preliminary inspection (see 3.2 and ) 4.3. Quality Assurance -11-

12 (Since specific questions to QA frequently arise only in the course of the inspection it generally makes sense to leave inspection of QA until just before the concluding discussion.) Quality Assurance programme Number and qualification of QA personnel, taking into account associated TSs and independent TSs Independence of QA from execution of study Arrangements for representatives Scope of work: Find out share of GLP work in activity as a whole - if necessary ask what additional tasks there are Is there an even balance of inspection and GLP office work? (In the case of toxicological studies there should be an inspection about every 4 weeks on average) Frequency of inspections independent of studies (including associated TSs and independent TSs) Interval between delivery of final report to QA and issue of QA statement Number of final reports inspected in the past year taking into account the nature of the studies Number of final report inspections still outstanding Interval between QA inspection and drafting of QA report to TFM Motivation/acceptance of QA (QA support by TFM and SD) Presence of all current SOPs (including list of SOPs with version numbers) at QA Nature of QA participation in drafting, revision and updating of SOPs Quality Assurance activity Audit of organisation and personnel Building plans, layout, construction and suitability of rooms Separation of work operations, test systems, clean/unclean areas, GLP/non-GLP areas Safety precautions, health protection measures Organisation charts, job descriptions, list of names and initials, documentation on initial and continuous training Human resources capacity Audit of study plans Checking of form and content of study plans before they are put into effect; documentation Are the approved study plans available before the start of the practical part of the study? -12-

13 Are amendments to the study plans and other GLP-relevant amendments by QA communicated in good time and is this documented? Planning and conduction of study-based, process-based and facilitybased inspections use of checklists, e.g. for critical phases such as receipt and registration of test items, selection of specimens to be retained, storage (for further details see also 4.3.3, and 4.3.6) Random sampling in the case of short-term studies (see Annex 5) Inspections of associated TSs or independent TSs Inspections of suppliers QA reports to SD and TFM; consequences of any defects found (Under 21 of the Chemicals Act inspectors have the right to examine QA inspection reports. They should, however, make use of this right only in justified exceptional cases.) Audit of measures carried out after complaints arising out of the last QA inspection Audit of final reports Form and content of final reports, correspondence with raw data, completeness of documentation; correct and full reproduction of results (QA statement) Audit of SOPs SOP administration (drafting, indexing, amendment, updating, dissemination) Form and content of newly drafted SOPs Archiving of all SOPs Documentation of all QA activities Quality Assurance and animal keeping How are animal keeping (quarantine, acclimatisation and veterinary examination on arrival), feed stores and compliance with safety programme monitored? Is there contact with the animal protection officer? Critical phases: Randomisation Weight measurement Feed consumption Preparation of forms of application Application Observation of experimental animals Blood sampling Preparation of specimens -13-

14 Analysis Killing and removal of organs Quality Assurance and field studies (Due to the multiplicity of sites/branch facilities particular problems may arise here and additional QA personnel may be necessary on site) QA inspections in the field in critical phases such as: Storage of test items for the duration of use Preparation of forms of application Application of the test item Sampling Preparation of specimens Storage of specimens Transport of specimens Fixing deadlines Defined communication routes between TFM, SD, QA and PI, if applicable; compliance and documentation Quality Assurance and data processing (DP) Audit of QA's organisation of DP systems Organisation chart and network topology of the DP system Validation concept Safety precautions Authorised access to the DP system DP system capacity DP system changes Does QA have direct read-only access to all raw data and can it get a history of all inputs and corrected inputs, e.g. using an audit trail? Does QA check all manual or non-validated on-line data input, processing and output processes of the DP system with adequate random sampling? Does QA check, where necessary, the validation and revalidation of the DP system? Does QA check the evaluation of old DP equipment for GLP conformity? Does QA have sufficient basic DP knowledge for assessing the validation of the DP system? Does the QA use the services of an outside expert? -14-

15 Quality Assurance and instrumental analysis or collection of physical-chemical data Reporting to QA exact time short critical phases are carried out or any changed times. Examples of critical phases: Preparation of solutions Removal of specimens Charging and start-up of apparatus (e.g. steam pressure measurement) See Annex 5 for procedure in the case of short-term studies 4.4. Inspection Preliminary remark As a rule inspection is carried out by all inspectors together (at least in pairs) Rooms/installations Checking that the function of the rooms corresponds to the designations in the building plans Checking the suitability of the rooms as regards size, apparatus, functionality, order, cleanness, etc Separate rooms or sections for: network servers, mainframe computers, node computer stores for apparatus and supplies areas for working with radioactive or sterile materials storage of test and reference items for as long as they are needed preparation of forms of application collection, storage and disposal of waste, test systems cleaning of materials (washing units) individual application areas (different processes) individual biological test systems clean/unclean areas archive rooms (separate for wet material), external order archive if necessary Adequate separation of the GLP studies from other studies (if they cannot be put in separate rooms, it must be possible to work in conformity with GLP in the non-glp area, i.e. all GLP rules are complied with up to the time of preparation of study plans and final reports) Checking of room conditions/environmental conditions: temperature light conditions air change -15-

16 relative humidity Monitoring of rooms/installations in accordance with SOPs, rules for unforeseeable events, alarms (rules for weekends and holidays) Questioning of personnel: on "current" SOPs (comprehension) on the progress of study in accordance with the study plan on raw data collection: direct recording of original and derived data, initialled and dated rules for amendments, corrections (the original records must be recognisable and the amendments furnished with date, reason and signature) in the case of raw data collection by computer: acceptance criteria, authorisation to amend raw data, acquisition of amendment by audit trail authentication of raw data copies on conduct in the case of unforeseeable events, e.g. power cut (is there an emergency generator available, are functional tests carried out and documented?) The proper functioning of an audit trail is checked by amending a raw data item as an example and checking whether it has been properly recorded and can be reproduced, e.g. using an example file Standard Operating Procedures Checking SOPs on the spot: see Annex 1 availability latest version readability authorisation completeness establishing who is responsible for dissemination and exchanging invalid SOPs for valid ones no unauthorised summaries no unauthorised changes Apparatus, materials and reagents Auditing maintenance, repair and release records, calibration and adjustment of apparatus (apparatus/logbooks), procedure if tolerance limits are exceeded -16-

17 Checking that containers are properly labelled in the case of test and reference items (at least with the expiry date, special storage instructions, opening date and shelf life if applicable) and reagents (provenance, identity, concentration, stability data, date of manufacture and expiry date, special storage instructions, any danger symbols pursuant to the Dangerous Substances Order) Disposal of materials and reagents Studies carried out on animals Qualification of animal minders Animal provenance documentation Quarantine for newly arrived animals; examinations on arrival and continuous documentation of health status (in case of sickness reject if necessary, giving reasons) Randomisation/allocation of animals Dealing with superfluous animals Unambiguous labelling of animals and cages/containers Monitoring the health of the animals, administration of medicines if required Quality and purity of feed (delivery note, composition and impurities certificate) Checking feed and water quality, what to do if defects are found Feed storage conditions Quality and purity of litter, substrate, etc Documentation of all stages of study (e.g. application, sampling, autopsy) for every animal Does the pathologist have a suitable method for recording data? (see also ) Disposal of cadavers General cleanness Cleaning of cages/containers, feed containers and other accessories Separation of clean and unclean areas (cage washing facilities, animal rooms) -17-

18 Conduct in the case of unforeseeable events EN-TRA-00 (DE) Documentation when materials (sections, blocks, etc.) are sent to associated or independent TSs or other TFs Studies carried out on microbial, cellular and subcellular test systems Does the TF have whatever official permits are necessary for dealing with pathogenic microorganisms (Federal Act on the Prevention of Contagious Diseases)? Are personnel given sufficient training as necessary on dealing with dangerous pathogenic test systems, and by whom? Are there any rules regarding keeping conditions and culture (e.g. climatic chamber, making the culture medium, cultivation) hygiene precautions, other safety measures, examining state of health of personnel prevention of contamination (sterility) for these test systems, and are they being complied with? Characterisation of the test system (provenance, species, strain) Disposal of biological test systems (collection, storage, decontamination and transport methods) Greenhouse and semi-field studies Test system: Species, variety, strain Provenance Quantity State of health (quarantine if necessary) Number and frequency of health checks Substrate: Provenance Composition Nutrient content Homogeneity Absence of disturbing impurities Care of the test system: Cultivation, reproduction and keeping conditions (in the case of plants: sowing, cuttings, refining, pruning if any, singling) Feeding (in the case of plants: supplying with water and nutrients) -18-

19 Measures to protect the test system against attack from harmful organisms In greenhouse only: Cleanness, air conditioning, temperature and humidity recording, illumination (intensity, duration), shading (duration), ventilation (mechanical protection against ingress of foreign and harmful organisms), sufficient size for separate keeping of test systems (in the case of plants: type of standing surface and watering, any measures against hardness of water; in the case of animals: type and size of container/housing) Test item: type and time of application Disposal of test systems and substrate What safety measures are provided for the personnel, are they aware and are they monitored (e.g. health protection)? What monitoring systems are there? Field studies (see ) Description of the test system (location, history of plot, plot size, position in relation to wind direction, adjacent areas, labelling, locatability, mapping; in the case of plants: species, variety, provenance of seed or plants, state of health, care measures such as pruning, tilling, fertilising, watering, plant protection; in the case of soils: type of soil, organic substances, ph value, tilling) Application of test item (calculation of dose, information on shelf life and behaviour for specific ph values of the water; type of application, e.g. pouring, spraying, scattering, dusting; type of apparatus, nozzle type, linkage; testing of application; frequency and times; if necessary fixing of dates on the basis of phenological information; recording of temperature and windspeed during application; removal of liquid residues; measures to prevent contamination, e.g. by drift) Labelling, maintenance and cleaning of apparatus (e.g. scales, pipettes, application equipment including nozzles, refrigerators, meteorological data recording instruments) Specimens for residue analyses (type and date of sampling, labelling and storage of specimens, checking of storage conditions, suitable transport to analytical laboratory, maintaining cold chain) Preventing contamination (test item kept sufficiently separate from specimens during storage and handling; measures in the case of apparatus, work tables, containers, rooms) -19-

20 Presence of SOPs, study plan and forms in the branch facility, recordings of communications (telephone calls, faxes), intermediate storage of raw data at the branch facility Cleanness (apparatus, containers, rooms) Disposal of residues of the test item and the test system, documentation Communication between LPE, SD, PI and QA; procedure for informing QA on critical phases such as application of test item and taking, preparation, storage and transport of specimens (dates to be specified in study plan) Studies in the area of instrumental analysis or collection of physicalchemical data Methods in particular for ensuring GLP and non-glp studies are at separate times Development of methods during the study requires timely additions/amendments to the study plan Unambiguous and durable labelling of apparatus and equipment modules Unambiguous matching of logbooks to equipment and modules raw data to equipment (in the case of modular systems, to the respective parts) printouts (e.g. chromatograms) to the respective specimens or test and reference solutions Full and complete documentation of the calculations from the raw data to the results in the final report Matching of raw data relating to more than one study (e.g. a standard for several studies) to the individual studies (e.g. by means of authenticated copies) SOPs for equipment Person responsible Instruction in routine operation, maintenance, calibration and functionality checking of the equipment (e.g. type and frequency, tolerances and procedure if tolerance limits are exceeded, results to be recorded, labelling in the event of malfunctions, informing the SD/hierarchical superior if things are unclear) In the case of non-routine stages in the work, references to the operating instructions may be given. There is no need for them to be recorded in the archives. -20-

21 If the operating instructions or parts of them are formally declared to be SOPs, they become a part of all authenticated versions and as SOPs have to be archived Audit of receipt, labelling and storage of test items, reagents and specimens, preparation, labelling and storage of solutions Test and reference items SOP on handover of the test item from the sponsor to the TF (e.g. handling, environmental conditions such as temperature and relative humidity, storage conditions, if necessary classification in accordance with Dangerous Substances Order) Authenticity of test item on arrival at TF: Procedure for verification of identity, e.g. by testing at last two specific characteristics from the analysis certificate, in exceptional cases return of a specimen to the manufacturer for confirmation or other duplicable method for establishing identity; otherwise a clear indication must be given in the study plan and the final report Labelling as test or reference item, clear coding Distribution of the test item in the Test Facility; documentation Accounting of quantity received, use and disposal of the test item (possibly return to manufacturer) Archiving reference samples of test and reference items Preparation of application form of test and reference items cleanness of apparatus avoidance of contamination Labelling, homogeneity, stability and storage of application form Data processing (see also 4.3.5) Is there an exact description of the computer system used? Does it show the network topology and data flow? Is there an inventory of the GLP computer equipment used? Are apparatus and modules unambiguously and durably labelled? Is there an inventory of the software the TF has purchased or developed itself? What methods are used to protect the computer systems from damage? -21-

22 Is there an SOP which specifies which data are to be regarded as raw data (electronically stored data or paper printouts)? Are there suitable methods available to protect against raw data losses (e.g. defective or incomplete data transmission)? Does the program used permit only authorised persons to correct input errors? Can this be verified (audit trail)? Are any changes made in accordance with GLP? Does the program allow data corrected after storage to be recognised as such? Can the original input be called up (audit trail)? Does the program used allow display of an error function? Has the DP system been developed, manufactured and validated by the manufacturer in accordance with recognised quality and technical standards? Does the DP system specification meet the requirements of the application? Is the computer equipment in the Test Facility subject to a validation concept? (What is validated when and by whom?) Is an acceptance test for the application carried out before first use? Is old apparatus validated retrospectively by means of a GLP conformity evaluation plan? What documented considerations is this based on and what documents are consulted for retrospective validation? Are there documented and approved rules for controlled system changes, i.e. exchange of hardware components (e.g. hard disk, processor) or changes to software components (e.g. update, upgrade, replacement) in computer equipment? Are there rules for revalidation after a control system change? Have computer systems been regularly revalidated in accordance with the validation concept? Are there specifications regarding the air conditioning in the computer room? How are they monitored? Is it ensured as far as necessary that the computer equipment has a continuous power supply? Are plausibility tests carried out on data input (e.g. dosing only after input of body weight)? -22-

23 How does the SD ensure that the data input is regularly and adequately checked for correctness? Are the storage times and conditions for electronically stored raw data GLP-compliant? Is an audit trail automatically generated with information in particular on: person, date of data input, date of data change, reason for change? Which data are input online or offline by clinicalpathological/haematological or environmental monitoring systems for a specific study or more than one study? Is there data matching between storage medium and printout and what is saved? Are the above points, where relevant and necessary, set out in SOPs in a reproducible way? -23-

24 4.5. Archiving See also the consensus paper of the Working Party on the Archiving and Storage of Records and Materials (possibly independent order archive: TS) General aspects of archiving Structural factors, e.g. protection against fire (fire-retardant design), water, theft and other negative influences Control of access, archive manager or representative Inventory list and organisation and indexing system for archived documents and materials (including discontinued studies), fast location QA inspection of data and materials archives Procedure in the case of preparation of several originals of final reports Data archive Audit of documents for completeness, e.g. study plan, raw data, final report, miscellaneous documents; source references for data covering more than one study, e.g. scales data, air conditioning control data, instrument calibration, any authorised copies Pagination or adequate method for fast location and for protection against loss and mix-up of the raw data belonging to a study, possibly also using study plan, final report and miscellaneous data List of contents of archived documents for each study Rules for borrowing and returning archived documents (as a rule, copies to be made) Ensuring legibility when data saved on magnetic media Method for microfilming data, audit Safe intermediate storage of data in associated TSs or independent TSs and communication to SD or archive (including order archive) Archiving of QA documents Chronological collection of all SOPs Archiving of data covering more than one study (logbooks, records of air conditioning checks, etc.) -24-

25 Archiving of building and floor plans EN-TRA-00 (DE) Archiving of organisation charts, personal files, Master Schedule Materials archive Archive for reference samples of test and reference items, labelling, duration of storage Archive for specimens, temperature control in the case of refrigerated storage Archive for wet items, special requirements e.g. for formaldehyde preparations Archive for paraffin wax blocks, sections, smears Intermediate storage of specimens in associated TSs or independent TSs; refrigeration, maintaining cold chain in transport Notification of QA before removal from archive at end of storage period 4.6. Audit of completed studies Selection of studies Selection as shortly as possible before or at beginning of inspection (see 3.2 and ) Studies should be relevant to study categories applied for and if possible suitable for submission to an evaluating authority Studies should be carried out, completed and archived in accordance with GLP and as a rule not older than the previous inspection Preparation for study audits Preparation of copies of study plans and final reports for memos, comparisons, etc., also translations if appropriate If appropriate, consultation with SD of the study in question and/or QA -25-

26 Carrying out the study audit Audit for completeness of documents (contents list, pagination as necessary), classification criteria and consistent coding Audit of dated signatures in original Audit of study plan (see Annex 2) Audit of raw data (random if necessary) for: reproducibility completeness (laboratory journals, delivery notes, air conditioning control data, apparatus logbooks, substance data sheets, etc.) correct amendments dated initials Audit of final report (see Annex 3) If parts of the study were not carried out in accordance with GLP, this must be noted in the SD's statement Audit for congruence of study plan, raw data and final report (systematic approach from study plan via raw data to final report or vice versa), e.g.: comparison of dates of beginning and end of practical part of a study and other relevant data between study plan, raw data and final report checking whether all requirements of study plan including those of the SOPs mentioned (disclosure) have been fulfilled in the final report (note any changes including date). Check time of notification of QA in the case of animal experiments, random checking or examination of individual animals on the basis of the reproducibility of the raw data throughout the study (possibly with the inclusion of an animal which died during the study) random check of individual raw data against the final report, also with regard to the correct presentation of the results If appropriate, supplementary audit of: personnel documents QA documentation (matching of QA inspections with the QA statement (dates, study phases and reports to TFM)) rooms, archives animal keeping reference samples of test and reference items, specimens SOPs valid at time of inspection raw data covering more than one study interfaces between TF and associated TSs or independent TSs procedure in the case of discontinued studies If the study audit is carried out not in the framework of a normal GLP inspection but in response to enquiries from the evaluating authorities, the following points are to be observed: -26-

27 determination of human resources requirement for the study selected and right to inspect personal documents audit of individual pieces of apparatus right to inspect records on the test item (possibly physical inspection of archive, comparison of quantities), systematic checking of raw data in light of enquiry possibly a brief look around the laboratory and questioning of relevant personnel Possibly take a look at particular procedures in a comparable current study Discussion of results of study audit Agreement within team of inspectors Discussion with SD, QA, TFM and if necessary others, e.g. PI Request of a supplement to the final report if there are relevant defects In the case of serious defects, classification of study as not GLPcompliant and immediate notification of Federal GLP Agency 4.7. Concluding discussion Participants: inspectors, TFM, SD, QA management, possibly archive manager, PI if applicable Communication of defects found, as a rule in writing (brief report) Setting deadline for rectifying defects Announcement of re-inspection in the case of serious defects Binding designation of Test Facility Determination and specific arrangement of study categories (see also and Annex 6) Any provisional vote taken by inspection team 5. INSPECTION REPORT 5.1. Name and address of TF and any associated TSs or independent TSs 5.2. Reason for and period of inspection -27-

28 5.3. Participants in inspection 5.4. Study categories (see Annex 6) 5.5. Names of structures audited/areas of TF pursuant to ChemVwV-GLP 1, Annex to Names of current studies inspected and completed studies audited 5.7. List of defects found (possible distinction between slight, medium and serious defects), any TF measures notified on the basis of it 5.8. Overall impression of TF 5.9. Inspection team's vote on granting of certificate Possible annexes to inspection report: Brief report in accordance with Layout of Test Facility (GLP area marked) Organisation chart(s) List of current, completed and discontinued studies (Master Schedule) List of SOPs in all areas Quality Assurance programme List of studies carried out/study categories for certificate if applicable, written opinion of TF on elimination of defects 1 Administrative Regulation relating to Chemicals (Good Laboratory Practice) -28-

29 Annex 1: Standard Operating Procedures 1. Requirements The Test Facility must have at its disposal written Standard Operating Procedures in the German language, approved by the Test Facility management. Standard Operating Procedures must be available on site. Only the latest version must be kept. Superseded versions must be either removed (collected in) or labelled as invalid. Technical manuals, operation instructions, etc. can be used as an additional help. If they are a part of the Standard Operating Procedure, they must be archived along with it. This is not necessary if they are only referred to in the Standard Operating Procedure and the main information in the manual is already contained in it. Formal requirements: Labelling with descriptive title and name Name of Test Facility Code and version number on each page Total number of pages including annexes Area of validity Distribution list Author and date of drafting Approval and date of entry into force (signature of Test Facility management) Documented visa of Quality Assurance Additional requirements: Source references or apparatus manufacturers' operating instructions Additions and amendments must be approved and dated (amendments guaranteed on all authorised copies) There must be audit and updating procedures available. A historical archive must be kept of all Standard Operating Procedures. Standard Operating Procedures for audit of apparatus, installations, etc., must contain instructions for cases where the prescribed tolerances or conditions are not complied with. In the "Organisation and Personnel" sector the points listed below require adequate written rules, but not necessarily in the form of Standard Operating Procedures: Organisation chart Task descriptions CVs Training and continuing training List of names, initials Distribution list for Standard Operating Procedures 2. At least the following areas must be covered by Standard Operating Procedures, while several of these points may be combined in a single SOP: a) Test and reference items -29-

30 Reception Identification/authentication Purity (composition, concentration of active ingredient) Labelling Handling Removal Preparation Use Stability Homogeneity and stability of mixtures (carriers) Reference samples Storage Disposal b) Apparatus, materials and reagents EN-TRA-00 (DE) Labelling of reagents Labelling of apparatus Operation Maintenance (logbooks) Cleaning (logbooks) Calibration, possibly indicating permissible tolerances Validation, operation, maintenance, safety, system change control and backup in the case of computer-assisted systems Expiry dates Preparation of reagents Preparation of application form Monitoring of environmental conditions c) Record-keeping, reporting, storage and retrieval Coding of studies Data collection Drafting of reports Indexation systems Data handling Validation of DP systems Keeping of records and reports Access rules Registration of borrowings and returns Preparation of Standard Operating Procedures (drafting, amendment, updating, authorisation, distribution, archiving) Drafting of study plans Historical development of Standard Operating Procedures d) Test systems Preparation of rooms Preparation and audit of room environment conditions Reception Quarantine Transfer (forwarding) Accommodation/storage Handling Characterisation Identification Permanent and unambiguous labelling Feeding, care, medical attention Storage of feed, litter, etc. Checking quality of feed and water, procedure if defects are found Cleaning of cages, feed containers and other accessories Separation of clean and unclean areas (cage washing facilities, animal rooms) Preparation of test systems

31 Randomisation Application Observation of test systems Examination of test systems Dealing with superfluous animals, plants, etc. Dealing with moribund or dead individual test systems Disposal of test systems Collection/taking of specimens Naming/labelling of specimens Handling of specimens (autopsy, histopathology) Placing and choosing location for test systems on study surfaces e) Quality Assurance procedures Audits Inspections Checking of study plans and final reports Reporting Quality Assurance statement Participation in the preparation of Standard Operating Procedures f) Methods - Standard Operating Procedures (analyses, studies) g) Computer-assisted systems Operation of DP system Responsibilities of personnel Safety measures Definition of raw data Method for determining specifications of apparatus Method for changing the programme Validation method Documentation method Regular audit of correct function Maintenance method Software development Acceptance tests and documentation Back-up method Archiving of data Making legible electronically recorded data h) Dispatch of materials and documents to associated/independent TSs or other TFs -31-

32 Annex 2: Study plans Name of study, code Descriptive title Declaration of type and purpose Designation of test item by trade name code name (IUPAC, CAS No, etc.) molecular formula structural formula batch Reference item (chemical name) Name and address of sponsor Name(s) and address(es) of TF(s), associated TS or independent TS Name and address of Study Director or representative Dated signatures to the study plan Study Director Test Facility management (only necessary in the case of standardised study plans for short-term studies) Quality Assurance (documented verification) Dates (planned deadlines for beginning and end of experimental phase) Study methods individual descriptions OECD study guidelines or similar special Standard Operating Procedures general Standard Operating Procedures Individual data (where applicable) justification of the choice of test system characterisation of the test system application method (justification) dosages details of the study set up field study: obtaining climatic data Full list of records to be kept Amendments, deviations and corrections -32-

33 justification and dated signature of Study Director Quality Assurance visa, signed and dated in good time notification, where appropriate, of the Test Facility management and/or the sponsor archiving of amendments with the study plan archiving of deviations with the raw data Specifications for field test systems: Study area site type of soil, ph value, organic substances arrangement, size and number of repetitions of study and control plots size and nature of separating strips, areas marking and mapping for the purpose of relocation history (e.g. previous crop, fertilisation measures, plant protection) for at least the two previous vegetation periods recording of environmental conditions such as temperature, precipitation, duration of sunshine, special events, in the case of greenhouses: periods of light/darkness, etc. Test system plant species, variety, age, interval soil parameters permitted care measures (avoiding interference with the test item) in the case of seeds: clone, providence, pre-treatment Study method description of type of application and of apparatus (spatial or area treatment, size of outriggers, type of nozzles, pressure, advance, tolerances, removal of spray fluid residues) application and sampling deadlines sampling methods, apparatus if appropriate, soil and plant specimens labelling, preparation, transport and storage of specimens method of despatch to sponsor, analytical laboratory or processing firm if appropriate, archiving of specimens -33-

34 Annex 3: Final reports Name of study, code Descriptive title Designation of test item by trade name code name (IUPAC, CAS No, etc.) molecular formula structural formula characterisation batch purity stability homogeneity and a note to say whether an authentication was carried out and if not, why not. Reference item (chemical name) Name(s) and address(es) of TF(s), associated TS or independent TS Name of Study Director, or representative Name of PI, if appropriate, or managing scientists from cooperating disciplines Dated GLP statement of Study Director (naming any phases not compliant with GLP) Dated signatures of Study Director, PI or managing scientists Dated Quality Assurance statement inspectors' deadlines type of inspections inspected phases of studies deadlines for reports to the Study Director and the TF management Dates (deadlines for beginning and end of experimental phase) Description of materials used Study methods individual description OECD study guidelines or similar specific Standard Operating Procedures Representation of results -34-

35 summary all information and data asked for in the study plan calculations and statistical methods evaluation and discussion conclusions Indication of where all the following are kept reference samples of test and reference items specimens raw data (in what form) study plan, including amendments/additions final report EN-TRA-00 (DE) Documentation classification criteria uniform coding completeness of raw data (contents list) perfect archiving of raw data (dated, initialled, justified, dated and initialled corrections) perfect representation of results (avoiding errors by the use of word processing or text modules and of transmission and calculation errors) pagination or comparable possibilities for checking Subsequent corrections and additions justification and dated signature of Study Director and, if appropriate, the management employee involved dated signature of Quality Assurance -35-

36 Annex 4: Field of application of Good Laboratory Practice in Germany The Chemicals Act makes it compulsory to comply with the GLP Principles for nonclinical experimental studies of substances or preparations, the results of which are intended to make possible the official evaluation of possible dangers to human beings and the environment. The Chemicals Administrative Regulation (GLP) lays down the field of application for chemicals, plant pesticides, medicaments, explosives, substances involved in dangerous goods transport and food and animal feedingstuffs additives. The following list (status as at December 1997) shows those studies which to the knowledge of the Federal GLP Agency are regarded by the competent evaluation authorities as studies which have to be GLP-compliant in the areas of chemicals, plant pesticides and medicaments. In the list, an asterisk denotes those physical-chemical studies which can be carried out in accordance with to the OECD consensus paper on short-term studies (see also Annex 5). -36-

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