{"product_id":"book-4c-2026-good-manufacturing-practice-in-the-european-union-reference-guide","title":"Book 4C:  2026 Good Manufacturing Practice in the European Union, Reference Guide","description":"\u003cdiv id=\"tabs\"\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#tabs-1\"\u003eDescription\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#tabs-2\"\u003eContents\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#tabs-3\"\u003eCover\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cdiv id=\"tabs-1\"\u003e\n\u003cp align=\"left\" class=\"bigblacktext\"\u003e\u003cspan class=\"smallgray\"\u003eThis spiral-bound, 5.5\" x 8.5\" book is a compilation of the official Eudralex GMP Guidleines in reduced size. It includes current guidelines as well as finalized guidelines coming into effect at a later date. (300 pages)\u003c\/span\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cspan color=\"#000099\" style=\"color: #000099;\"\u003eHow is this Book Used?\u003c\/span\u003e\u003cspan class=\"smallgray\"\u003e\u003cbr\u003e• As a training aid for new and existing staff\u003cbr\u003e• As an on-the-job reference source\u003cbr\u003e• As a preparatory aid for an FDA inspection\u003cbr\u003e\u003c\/span\u003e\u003cbr\u003e\u003cspan color=\"#000099\" style=\"color: #000099;\"\u003eWhat's the Price?\u003c\/span\u003e\u003cbr\u003e\u003cspan class=\"smallgray\"\u003e• 1-249 copies:  $18.95             • 250-499 copies:  $17.95\u003cbr\u003e• 500-749 copies: $16.95          • 750+ copies:  $15.95\u003cbr\u003e\u003cspan color=\"#000099\" style=\"color: #000099;\"\u003e\u003cbr\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan color=\"#000099\" style=\"color: #000099;\"\u003eCustom Cover Prices*?\u003c\/span\u003e\u003cspan class=\"smallgray\"\u003e\u003cbr\u003e• 1-24 copies:  unavailable             • 25-100 copies:  $2.00\/book\u003cbr\u003e• 100-249 copies: $1.00\/book        • 250+ copies:  No charge \u003cspan color=\"#000099\" style=\"color: #000099;\"\u003e\u003c\/span\u003e\u003cbr\u003e\u003cbr\u003e\u003cspan color=\"#000099\" style=\"color: #000099;\"\u003e* Based on quantities of a single book title\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"tabs-2\"\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e \u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong\u003eThe Rules Governing Medicinal Products in the EU\u003c\/strong\u003e\u003cbr\u003e\u003cstrong\u003eVolume 4: Good Manufacturing Practice Guidelines\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong\u003ePart I - Basic Requirements for Medicinal Products\u003c\/strong\u003e \u003cbr\u003e      • Chapter 1: Pharmaceutical Quality System \u003cbr\u003e      • Chapter 2: Personnel\u003cbr\u003e      • Chapter 3: Premises and Equipment \u003cbr\u003e      • Chapter 4: Documentation\u003cbr\u003e      • Chapter 5: Production \u003cbr\u003e      • Chapter 6: Quality Control\u003cbr\u003e      • Chapter 7: Outsourced Activities\u003cbr\u003e      • Chapter 8: Complaints and Product Recall \u003cbr\u003e      • Chapter 9: Self Inspection\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong\u003ePart II - Basic Requirements for Active Substances used as Starting Materials\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong\u003ePart III - GMP Related Documents\u003c\/strong\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eExplanatory Notes on Site Master File \u003c\/li\u003e\n\u003cli\u003eICH Q9 Quality Risk Management\u003c\/li\u003e\n\u003cli\u003eICH Q10 Note for Guidance on Pharmaceutical Quality System\u003c\/li\u003e\n\u003cli\u003eMRA Batch Certificate\u003c\/li\u003e\n\u003cli\u003eTemplate for the 'Written Confirmation' for Active Substances Exported to the European Union for Medicinal Products for Human Use\u003c\/li\u003e\n\u003cli\u003eGuideline on Setting Health Based Exposure Limits for use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities\u003c\/li\u003e\n\u003cli\u003eGuidelines of 19 March 2015 on the Formalised Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients of Medicinal Products for Human Use\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong\u003eSelected Annexes\u003c\/strong\u003e\u003cbr\u003e     • Annex 1: Manufacture of Sterile Medicinal Products\u003cbr\u003e     • Annex 2: Manufacture of Biological Active Substances and Medicinal Products for\u003cbr\u003e       Human Use\u003cbr\u003e     • Annex 11: Computerised Systems\u003cbr\u003e     • Annex 13: Manufacture of Investigational Medicinal Products\u003cbr\u003e     • Annex 14: Manufacture of Medicinal Products Derived from Human Blood or Plasma \u003cbr\u003e\u003cbr\u003e\u003cstrong\u003eGlossary\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong\u003e• Commission Directive 2003\/94\/EC of 8 October 2003 on GMP\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong\u003e• Commission Delegated Regulation (EU) No. 1252\/2014 with Regard to Principles\u003c\/strong\u003e\u003cbr\u003e\u003cstrong\u003e   and Guidelines of GMP\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003c\/div\u003e\n  \u003cdiv id=\"tabs-3\"\u003e\n\u003cp\u003eClick \u003ca rel=\"noopener\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/book4ccoiled.pdf?v=1744819356\" target=\"_blank\"\u003ehere\u003c\/a\u003e to see an enlarged pdf cover \u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"Clinical Research Resources, LLC","offers":[{"title":"Default Title","offer_id":44561131405427,"sku":null,"price":18.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/2026book4ccoiled.png?v=1775164853","url":"https:\/\/www.clinicalresearchresources.com\/products\/book-4c-2026-good-manufacturing-practice-in-the-european-union-reference-guide","provider":"Clinical Research Resources, LLC","version":"1.0","type":"link"}