{"product_id":"eu-gmp-annex-1-2022-for-sterile-production-with-tips-hints-guidelines-applies-to-pics-and-fda-paperback","title":"EU-GMP Annex 1-2022 for sterile production with tips \u0026 hints: Guidelines applies to PICs and FDA - Paperback","description":"\u003cdiv\u003e\u003cp style=\"text-align: right;\"\u003e\u003ca href=\"https:\/\/reportcopyrightinfringement.com\/\" target=\"_blank\" rel=\"nofollow\"\u003e\u003cb\u003eReport copyright infringement\u003c\/b\u003e\u003c\/a\u003e\u003c\/p\u003e\u003c\/div\u003e\u003cp\u003eby \u003cb\u003eParviz Bayegi\u003c\/b\u003e (Author)\u003c\/p\u003e\u003cp\u003eIn 2022, the European Medicines Agency (EMA), in collaboration with the PIC organization and the US FDA (cGMP), published a new EU GMP guideline that will come into force in 2023. The new Annex 1 is significantly more extensive than its predecessor and comprises 59 pages with 11 chapters. Chapter 8 in particular, with its 139 points on specific production processes, places high demands on manufacturers. \u003c\/p\u003e\u003cp\u003e\u003c\/p\u003eIn order to better understand and implement the complex content of the new Annex 1, a second column with technical explanations has been added to this book in addition to the original English text. These are based on decades of practice in production and quality management and offer valuable assistance for the practical application of the new guidelines.\n            \u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 168\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 0.36 x 10 x 7 IN\u003c\/div\u003e\n            \u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e November 20, 2024\u003c\/div\u003e\n            ","brand":"BooksCloud","offers":[{"title":"Default Title","offer_id":67602182832402,"sku":"9798300645304","price":133.65,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0941\/2211\/5346\/files\/K54f8VpZTD9798300645304.webp?v=1791323486","url":"https:\/\/ckbookstore.net\/products\/eu-gmp-annex-1-2022-for-sterile-production-with-tips-hints-guidelines-applies-to-pics-and-fda-paperback","provider":"CK BOOKSTORE","version":"1.0","type":"link"}