{"product_id":"the-fda-and-worldwide-current-good-manufacturing-practices-and-quality-system-requirements-guidebook-for-finished-pharmaceuticals","title":"The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals","description":"\u003cp\u003eThis guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations\/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC\/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC\/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cb\u003eAuthor:\u003c\/b\u003e José Rodríguez-Pérez\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003ePublisher:\u003c\/b\u003e Quality Press\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003ePublished:\u003c\/b\u003e 2014-08-15\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003ePages:\u003c\/b\u003e 246\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Quality Press","offers":[{"title":"Default Title","offer_id":62800420372851,"sku":"9780873898690","price":200.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0987\/0812\/8115\/files\/content_58135c21-a4b9-4813-86bf-86b563e9b26f.jpg?v=1777735351","url":"https:\/\/readaura.store\/products\/the-fda-and-worldwide-current-good-manufacturing-practices-and-quality-system-requirements-guidebook-for-finished-pharmaceuticals","provider":"Read Aura","version":"1.0","type":"link"}