In some cases, it may be difficult to obtain an 173 identical matrix to that of the study samples (e.g., rare matrices such as tissue, cerebrospinal 174 fluid, bile). endobj QfÊ ÃMlˆ¨@DE� €£¡H¬ˆb!(¨`HPb0Š¨¨dFÖJ|yyïåå÷ǽßÚgïs÷Ù{Ÿµ. <> $O./– ™'àz8ÓW…Gбı x€¦ 0Y驾AîÁ@$/7zºÈ ü‹ŞHü¾eèéO§ƒÿOÒ¬T¾ È_ÄælN:KÄù"NʤŠí3"¦Æ$ŠF‰™/JPÄrb�[䥟}ÙQÌìd[ÄâœSÙÉl1÷ˆx{†�#bÄGÄ\N¦ˆo‹X3I˜Ìñ[ql2‡™ Š$¶8¬x›ˆ˜Ätñr p¤¸/8æp²âC¹¤¤fó¹qñº.K�njmÍ {r2“8�¡?“•Èä³é. Regional GMP requirements, the ICH Q7 Guideline, “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, and ISO quality management system guidelines form the foundation for ICH Q10. 14 0 obj

!!!! Search for FDA Guidance Documents <> <> 0000002174 00000 n ICH M10 Guideline . <>/ExtGState<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model.You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))If unable to submit comments online, please mail written comments to:

ַ#�|A7�����c8�z��P+q$h���&�q^X�����M� vP����,v�h���I�;Z�R@��I]�N!#�ꤐ�V�CHnl�t�Tq�"�Ɩ�@��G���N�br����jM�Tp�έ�r9���*&wqA�S�+@9]�º(��U E�G��� u��C5S���?RS�� ��D����v�\�"�w4�9��9�C���e��i��u5$%�܆h/�(�>�6�c�YC�ѽ�j�mA�P$KZ ��8p$��RA��������0�RX�C�]72~��8�Ӹ�t:,t{�KRg��B���#BKo7�,)�Ƿ���̲Q�$�Uh�I8�A�VgM��{� =P�L�e�em�[�5�PiB� ���1?*�?���l���>1���p�����{|o���*��������w�t���J������E���ko�w�ʏo8��?�4p��"�B���49+4&J���C�ɽ$u�? To meet the objectives described below, ICH Q10 augments GMPs by describing specific quality system elements and management responsibilities.

To meet the objectives described below, ICH Q10 augments GMPs by 21 0 obj x��Z[O9~�����L�8�{,U� �gف�t@��+�:\g��r*[�����SP�l��PY�Uܖ��o�fC0�RhjL����n�)u�t�~��7�nAa#t�#�n��'��6� �%��y� ��~%��߄���I`��/��ۑ;��h�t8=>�;�$ҵ��5��A�TBӁX���JE�C�z�O�4C�[|,cG��(��΅��@p�j�ay����9�Y4��S�e��̸�Mkt�p/��5f�jA>q��ϐ6~�ț�Y�ڠ ��GV\��xH���AJ������ݒ�(k�

7 . 17 0 obj Sciences pharmaceutiques. This internationally harmonized guidance is intended to assist pharmaceutical manufacturers by describing a model for an effective quality management system for the pharmaceutical industry, referred to as the pharmaceutical quality system. 0000003829 00000 n Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model. <>

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Throughout this guidance, the term pharmaceutical quality system refers to the ICH Q10 model. endstream endobj 545 0 obj<>/Outlines 73 0 R/Metadata 111 0 R/PieceInfo<>>>/Pages 107 0 R/PageLayout/SinglePage/OCProperties<>/StructTreeRoot 113 0 R/Type/Catalog/LastModified(D:20090225085328)/PageLabels 105 0 R>> endobj 546 0 obj<>/PageElement<>>>/Name(Background)/Type/OCG>> endobj 547 0 obj<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC/ImageI]/Properties<>/ExtGState<>>>/Type/Page>> endobj 548 0 obj[/Indexed 551 0 R 255 556 0 R] endobj 549 0 obj<> endobj 550 0 obj<>stream �j����3d1��I�tl�f~.Z�Ɣ�`4��� S�������Ϟ -b9֐j9�\QkJB Ш3�. 0000003009 00000 n 15 0 obj D’ICH Q8 à Q10: la maîtrise des changements dans un système de gestion de la qualité. endobj Active Pharmaceutical Ingredients,” and ISO quality management system guidelines form the foundation for ICH Q10.

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2014. dumas-01104900! 0000011263 00000 n Le CIH édite plusieurs lignes directrices, constituant une base pour les bonnes pratiques de fabrication (BPF, ou GMP en anglais), avec l'ICH Q1 pour la stabilité, ICH Q6 pour les spécifications, ICH Q10 pour le système de qualité pharmaceutique, etc.

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