{"product_id":"9780873898690","title":"The Fda And Worldwide Current Good Manufacturing Practices And Quality System Requirements Guidebook For Finished Pharmaceuticals","description":"This 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.\u003cbr\u003e\u003cbr\u003e\u003cbr\u003e\u003cul\u003e\n\u003cli\u003e| \u003cb\u003eAuthor: \u003c\/b\u003eJosé Rodríguez-Pérez\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003ePublisher: \u003c\/b\u003eQuality Press\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003ePublication Date: \u003c\/b\u003eApr 30, 2014\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003eNumber of Pages: \u003c\/b\u003e396 pages\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003eLanguage: \u003c\/b\u003eEnglish\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003eBinding: \u003c\/b\u003eHardcover\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003eISBN-10: \u003c\/b\u003e0873898699\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003eISBN-13: \u003c\/b\u003e9780873898690\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Quality Press","offers":[{"title":"Default Title","offer_id":49113428033841,"sku":"9780873898690","price":132.81,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0798\/8215\/8385\/files\/9780873898690.jpg?v=1714579958","url":"https:\/\/www.recomparo.com\/products\/9780873898690","provider":"ReComparo.com","version":"1.0","type":"link"}