Transcription of Annex 9 Guidelines on packaging for …
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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 in thehands of the patients for whom they are the manufacture of pharmaceutical products, quality assurance isdefined as the totality of the arrangements made with the object ofensuring that pharmaceutical products are of the quality required fortheir intended use (1).
122 General bulk product Any product that has completed all the processing stages up to, but not including, final packaging (1).containers A container for pharmaceutical use is an article which holds or is
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