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(GIVIMP) for the Development and Implementation of in Vitro Methods for 829 Regulatory Use in Human Safety Assessment

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(GIVIMP) for the Development and Implementation of in Vitro Methods for 829 Regulatory Use in Human Safety Assessment 1 2 Draft GUIDANCE DOCUMENT ON GOOD IN VITRO METHOD PRACTICES (GIVIMP) 3 FOR THE DEVELOPMENT AND IMPLEMENTATION OF IN VITRO METHODS FOR 4 REGULATORY USE IN HUMAN SAFETY ASSESSMENT 5 6 FOREWORD 7 8 A guidance document on Good In Vitro Method Practices (GIVIMP) for the development and 9 implementation of in vitro methods for regulatory use in human safety assessment was 10 identified as a high priority requirement. The aim is to reduce the uncertainties in cell and 11 tissue-based in vitro method derived predictions by applying all necessary good scientific, 12 technical and quality practices from in vitro method development to in vitro method 13 implementation for regulatory use. 14 The draft guidance is coordinated by the European validation body EURL ECVAM and has 15 been accepted on the work plan of the OECD test guideline programme since April 2015 as a 16 joint activity between the Working Group on Good Laboratory Practice (GLP) and the 17 Working Group of the National Coordinators of the Test Guidelines Programme (WNT). 18 The draft document prepared by the principal co-authors has been sent in September 2016 to 19 all 37 members of the European Union Network of Laboratories for the Validation of 20 Alternative Methods (EU-NETVAL1) and has been subsequently discussed at the EU- 21 NETVAL meeting on the 10th of October 2016. 22 By November/December 2016 the comments of the OECD Working Group on GLP and 23 nominated experts of the OECD WNT will be forwarded to EURL ECVAM who will 24 incorporate these and prepare an updated version. A second round of commenting shall be 25 concluded in the beginning of 2017. EURL ECVAM shall then prepare the final GIVIMP 26 version, which will be submitted to OECD for proposed adoption at the OECD Joint Meeting 27 in April 2017. 28 1 https://eurl-ecvam.jrc.ec.europa.eu/eu-netval Field Code Changed 1 29 TABLE OF CONTENTS 30 31 32 Field Code Changed 33 Glossary of important terms used in the Guidance Document ..................................... 5 34 Introduction ....................................................................................................... 15 Field Code Changed 35 Scope ................................................................................................................ 17 Field Code Changed 36 1 Responsibilities .............................................................................................. 19 Field Code Changed 37 1.1 In vitro method developers ....................................................................... 19 Field Code Changed 38 1.2 Test system providers ............................................................................... 20 Field Code Changed 39 1.3 Validation bodies ...................................................................................... 21 Field Code Changed 40 1.4 Producers of equipment, materials and reagents .......................................... 23 Field Code Changed 41 1.5 In vitro method end-users ......................................................................... 23 Field Code Changed 42 1.6 Receiving authorities ................................................................................ 24 Field Code Changed 43 1.7 GLP monitoring authorities ........................................................................ 25 Field Code Changed 44 1.8 Accreditation bodies ................................................................................. 26 Field Code Changed 45 1.9 OECD ..................................................................................................... 27 Field Code Changed 46 2 Quality Considerations.................................................................................... 28 Field Code Changed 47 2.1 Quality assurance versus quality control ..................................................... 28 Field Code Changed 48 2.2 Quality Control of test system .................................................................... 28 Field Code Changed 49 2.3 Quality control of consumables and reagents ............................................... 29 Field Code Changed 50 2.4 Data management ................................................................................... 30 Field Code Changed 51 2.5 Types of documentation ............................................................................ 31 Field Code Changed 52 2.6 Staff training and development .................................................................. 32 Field Code Changed 53 2.7 Assurance of data integrity ........................................................................ 33 Field Code Changed 54 3 Facilities ....................................................................................................... 36 Field Code Changed 55 3.1 Containment ............................................................................................ 37 Field Code Changed 56 3.2 Level of separation to avoid cross-contamination ......................................... 38 Field Code Changed 57 3.3 Air handling, water supply, environmental control, heating and cooling ........... 39 Field Code Changed 58 3.4 Cell and tissue culture transportation and cryostorage .................................. 40 Field Code Changed 59 3.5 Quarantine for new test systems ................................................................ 41 Field Code Changed 60 4 Apparatus, material and reagents .................................................................... 42 Field Code Changed 61 4.1 Apparatus ............................................................................................... 42 Field Code Changed 62 4.2 Materials and reagents.............................................................................. 44 Field Code Changed 63 4.3 Basal medium .......................................................................................... 45 Field Code Changed 64 4.3.1 The use of serum in cell culture .......................................................... 45 Field Code Changed 65 4.3.2 Serum-free media and serum replacements ......................................... 47 Field Code Changed 66 4.4 The use of antibiotics in cell culture ............................................................ 47 Field Code Changed 67 4.5 Additional media components .................................................................... 48 Field Code Changed 2 68 4.6 Dedicated media to particular cell lines ....................................................... 48 Field Code Changed 69 5 Test Systems ................................................................................................ 49 Field Code Changed 70 5.1 GCCP ...................................................................................................... 49 Field Code Changed 71 5.2 Cell and tissue sourcing ............................................................................ 49 Field Code Changed 72 5.3 Handling and maintenance of the test system .............................................. 50 Field Code Changed 73 5.4 Cryopreservation ..................................................................................... 52 Field Code Changed 74 5.5 Cell line identity and genetic aberrations ..................................................... 52 Field Code Changed 75 5.6 Contaminants screening: sterility, mycoplasma, virus ................................... 53 Field Code Changed 76 5.7 Quality Control ........................................................................................ 54 Field Code Changed 77 5.8 Biomarkers and functional tests to confirm the required cell function state ...... 55 Field Code Changed 78 5.9 Special issues for microbial strains ............................................................. 55 Field Code Changed 79 5.10 Qualification of reference strains ............................................................ 55 Field Code Changed 80 6 Test and reference items ................................................................................ 57 Field Code Changed 81 6.1 Test item ................................................................................................ 57 Field Code Changed 82 6.1.1 Considerations during the development of the method .......................... 57 Field Code Changed 83 6.1.2 Considerations for the final user of the validated method ....................... 61 Field Code Changed 84 6.2 Interaction between test item and test system ............................................ 61 Field Code Changed 85 6.2.1 Interference with the test system ....................................................... 62 Field Code Changed 86 6.2.2 Interference with in vitro method endpoint ........................................... 67 Field Code Changed 87 6.2.3 Interference with the analytical endpoint ............................................. 67 Field Code Changed 88 6.2.4 Consideration of interferences not coming from the active ingredient ...... 68 Field Code Changed 89 6.3 Biokinetics / dose extrapolation ................................................................. 68 Field Code Changed 90 6.3.1 Kinetic processes .............................................................................. 69 Field Code Changed 91 6.3.2 Measurement of free concentration /passive dosing .............................. 71 Field Code Changed 92 6.4 Reference and control items ...................................................................... 73 Field Code Changed 93 6.5 Use of proficiency chemicals .....................................................................
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