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Annex 9 Guidelines on packaging for …

119 World Health OrganizationWHO Technical Report Series, No. 902, 2002 Annex 9 guidelines on packaging for pharmaceuticalproductsIntroductory of of and , relabelling and inserts for patients (patient information leaflets) of of materials and of or types of assurance aspects of and of of the in The international for dosage form requirements for containers in Europe, Japanand the Standards145 References145 Bibliography147 Appendix 1 Storage areas150 Appendix 2 Labels151 Appendix 3 Self-inspection and quality audits152 Appendix 4 International Standards on packaging154 Introductory noteThis review of the various elements of the packaging of a pharmaceu-tical product is aimed at ensuring that medicines arrive safely i

120 5.2 Pharmacopoeial requirements for containers in Europe, Japan and the USA 144 5.2.1 Glass containers 144 5.2.2 Plastic containers 144 5.2.3 Rubber closures 144 5.3 International Standards 145 References 145 Bibliography 147 Appendix 1 Storage areas 150 Appendix 2 Labels 151 Appendix 3 Self-inspection and quality audits 152

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