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1 1 2 3 4 5 6 7 a Guidance Document on Good in Vitro Method Practices 1 2 Draft GUIDANCE DOCUMENT ON GOOD IN VITRO METHOD PRACTICES (GIVIMP) 3 FOR THE DEVELOPMENT AND IMPLEMENTATION OF IN VITRO METHODS FOR 4 REGULATORY USE IN HUMAN SAFETY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 by the OECD. The aim of this guidance document is 11 to reduce the uncertainties in cell and tissue-based in vitro method derived predictions by 12 applying all necessary good scientific, technical and quality practices from in vitro method 13 development to in vitro method implementation for regulatory use. This guidance document 14 also applies to in vitro methods already accepted by the OECD. 15 Development of GIVIMP began in 2013 when the WG GLP and the WNT agreed that there 16 was merit in having guidance for OECD countries on these important issues. The draft 17 guidance was coordinated by the European validation body EURL ECVAM and was 18 accepted on the work plan of the OECD test guideline programme in April 2015 as a joint 19 activity between the Working Group on Good Laboratory Practice (GLP) and the Working 20 Group of the National Coordinators of the Test Guidelines Programme (WNT). 21 The guidance is targeted primarily at end-users that implement in vitro methods, but also 22 provides guidance for in vitro method developers. The document satisfies objectives defined 23 in the original project proposal1 and includes 24 • A detailed update on good practices for state-of-the-art in vitro methods applied to 25 regulatory human safety assessment of chemicals of various kinds. 26 • Guidance to users and implementers of in vitro methods to help to ensure that SOPs 27 of such methods are well-designed, robust, well-defined and described and can be 28 carried out in a GLP environment, which is essential for use in a regulatory context. 29 • Guidance on minimum SOP requirements and reporting features (e.g. equipment 30 requirements, acceptance criteria for the different steps in the in vitro method SOP, 31 indications of maximum repetitions after invalid in vitro method data etc.) to strive for 32 more harmonised approaches for today's regulatory needs in the field of human safety 33 assessment. 34 • Description of the key aspects that may impact the reliability and relevance of the in 35 vitro data for quantitative human safety assessment purposes. 36 • Description of the importance of applying good experimental design, establishing 37 acceptance criteria, describing equipment requirements, and performance standards 38 based on scientific evidence from the generated in vitro datasets. 39 In addition to a first commenting round of the draft document that took place in fall 2016, the 40 development and revisions of the GIVIMP has occurred with input from a group of experts 41 from both the test guidelines programme and GLP. The expert group provided input through 42 teleconferences, a face-to-face meeting (March 2017), and two rounds of written comment. 43 The group agreed on content, structure, and wording of the GIVIMP. 1 Reference to the SPSF 1 44 In January 2017 the first round of comments of the OECD Working Group on GLP and 45 nominated experts of the OECD WNT were forwarded to EURL ECVAM who incorporated 46 these comments, where applicable, and prepared an updated version. Delegates of the OECD 47 Good In Vitro Method Practices Expert Group addressed specific outstanding issues on the 48 23th and 24th of March 2017, so as to provide the OECD with an updated version ready to 49 enter the second OECD commenting round. After this round, during summer 2017, EURL 50 ECVAM shall prepare the final GIVIMP version, which will be submitted to OECD for 51 adoption. 2 52 TABLE OF CONTENTS 53 Glossary of terms used in the Guidance Document ................................................................... 7 54 Introduction .............................................................................................................................. 19 55 Scope ........................................................................................................................................ 21 56 1 Roles and Responsibilities ................................................................................................ 23 57 1.1 In vitro method developers ........................................................................................ 23 58 1.2 Test system providers ................................................................................................ 25 59 1.3 Validation bodies ....................................................................................................... 27 60 1.4 Suppliers of equipment, materials and reagents ........................................................ 28 61 1.5 In vitro method users ................................................................................................. 29 62 1.6 Sponsor ...................................................................................................................... 29 63 1.7 GLP monitoring authorities ....................................................................................... 30 64 1.8 Receiving authorities ................................................................................................. 31 65 2 Quality Considerations ...................................................................................................... 33 66 2.1 Quality assurance and quality control ........................................................................ 34 67 2.2 Quality risk assessment .............................................................................................. 34 68 2.3 Quality control charts ................................................................................................ 35 69 2.4 Quality control of test systems .................................................................................. 37 70 2.5 Quality Control of consumables and reagents ........................................................... 39 71 2.6 Staff training and development .................................................................................. 40 72 2.7 Types of documentation ............................................................................................ 40 73 2.8 Quality considerations regarding electronic data integrity ........................................ 41 74 3 Facilities ............................................................................................................................ 43 75 3.1 Facility design ............................................................................................................ 43 76 3.2 Safety, risk assessment and management .................................................................. 45 77 3.2.1 Risk Groups ....................................................................................................... 45 78 3.2.2 Biosafety Levels................................................................................................. 46 79 3.2.3 Biological safety cabinets .................................................................................. 47 80 3.2.4 Waste disposal ................................................................................................... 48 81 3.3 Strategies to avoid cross-contamination .................................................................... 49 82 3.4 Air handling, water supply, environmental control, heating and cooling ................. 51 83 3.5 Quarantine for new test systems ................................................................................ 51 84 4 Apparatus, material and reagents ...................................................................................... 53 85 4.1 Apparatus ................................................................................................................... 53 86 4.2 Materials and reagents ............................................................................................... 55 3 87 4.3 Use of media in cell culture ....................................................................................... 56 88 4.3.1 The use of animal sourced serum in cell culture ................................................ 57 89 4.3.2 The use of animal sourced serum in cell culture for endocrine activity ............ 57 90 4.3.3 Alternatives to the use of animal sourced serum ............................................... 58 91 4.3.4 The use of phenol red in cell culture .................................................................. 60 92 4.4 The use of antibiotics in cell culture .......................................................................... 60 93 4.5 Additional media components ................................................................................... 60 94 4.6 Dedicated media for particular cell lines ................................................................... 61 95 5 Test systems ...................................................................................................................... 62 96 5.1 Guidance on Good Cell Culture Practice ................................................................... 62 97 5.2 Cell and tissue sourcing ............................................................................................. 63 98 5.3 Cell and tissue culture transportation .......................................................................
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