{"id":687,"date":"2021-07-28T17:19:32","date_gmt":"2021-07-28T15:19:32","guid":{"rendered":"https:\/\/alpinapharm.ch\/?page_id=687"},"modified":"2021-07-28T17:19:32","modified_gmt":"2021-07-28T15:19:32","slug":"supplier-qualification-and-management","status":"publish","type":"page","link":"https:\/\/alpinapharm.ch\/en\/supplier-qualification-and-management\/","title":{"rendered":"Supplier qualification and management"},"content":{"rendered":"<section class=\"l-section wpb_row height_medium full_height valign_center\"><div class=\"l-section-h i-cf\"><div class=\"g-cols via_flex valign_top type_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"g-cols wpb_row via_flex valign_top type_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h1 class=\"header\">Supplier qualification and management<\/h1>\n<\/div><\/div><\/div><\/div><\/div><\/div><div class=\"w-separator trenner size_medium with_line width_default thick_1 style_solid color_primary align_center with_text with_content\"><div class=\"w-separator-h\"><h6 class=\"w-separator-text\"><span>AP<\/span><\/h6><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default\"><div class=\"vc_col-sm-6 wpb_column vc_column_container animate_afl\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column us_custom_7e20fa79 animate_this\"><div class=\"wpb_wrapper\"><p>Supplier qualification and outsourcing expectations are laid down in EU-Directive 2001\/83\/EC (article 8, article 46, article 46b), EU-GMP Guidelines (chapters 5, chapter 7, annex 16) and national legislations.<\/p>\n<p>Outsourced activities must be controlled by the pharmaceutical manufacturers and marketing authorization holders. The activities go beyond performing audits and establishing audit reports. Supplier qualification must be part of the quality management system to ensure the quality of all materials and services used.<\/p>\n<p>Supplier qualification is a risk assessment tool which requires a well-structured documentation system for ongoing supplier evaluation. Regular supplier assessment and re-qualification are required. The quality of the supplied goods or services as well as changes at the supplier must be considered for the assessment.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-6 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-image us_custom_47474b22 animate_this align_none\"><div class=\"w-image-h\"><img loading=\"lazy\" decoding=\"async\" width=\"900\" height=\"600\" src=\"https:\/\/alpinapharm.ch\/wp-content\/uploads\/supplier.jpg\" class=\"attachment-full size-full\" alt=\"Supplier - Alpinapharm.ch | Pharma Consulting | Michael Hatour - Switzerland | Product Quality Review activities - Complaint management - Training management\" srcset=\"https:\/\/alpinapharm.ch\/wp-content\/uploads\/supplier.jpg 900w, https:\/\/alpinapharm.ch\/wp-content\/uploads\/supplier-300x200.jpg 300w, https:\/\/alpinapharm.ch\/wp-content\/uploads\/supplier-600x400.jpg 600w, https:\/\/alpinapharm.ch\/wp-content\/uploads\/supplier-768x512.jpg 768w\" sizes=\"auto, (max-width: 900px) 100vw, 900px\" \/><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"g-cols wpb_row via_flex valign_top type_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container \"><div class=\"vc_column-inner us_custom_60e9caca animate_this\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column mt-30\"><div class=\"wpb_wrapper\"><p>Supplier qualification assures that all materials and services meet the GMP requirements and your internal acceptance criteria. It mitigates potential risk and increases the supply chain transparency to provide a consistent quality of the product.<\/p>\n<p>To assure proper supplier qualification and continuous oversight we at Alpinapharm assist you with the supplier qualification and management process as we:<\/p>\n<ul>\n<li>Gather all vendor information and enter all required data in your data management system.<\/li>\n<li>Evaluate essential information and perform risk assessment according to your internal requirements.<\/li>\n<li>Perform regular controls for a continuous evaluation.<\/li>\n<li>Follow up on activities (vendor related complaints, audit CAPAs, etc.) and prepare reports.<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-687","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - 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