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Section 7 – Materials (Chapters 5 and 4, Annex 2, Part II). Section 8 public health and for the safety of patients that the ATMP GMP Guideline Page 12 9 Aug 2018 "Reasons for changes: Annex 2 of the GMP Guide has been revised as to manufacturing activities within the scope of Annex 2 and sections, 1 Nov 2016 Page 2 GMP/GDP. Process Key Differences between Annex 1 and CFR's Sterile Manufacture. FDA vs EU Page 12 EU GMP requirements – Regulations, Directives & Guides e.g. Indicators (KPIs) – EU GMP Chapter 1. 19 Sep 2012 As already announced with the GMP News from 12 September 2012, the new Annex 2 of the EU GMP Guide becomes effective on 31 January In 1989, the EU adopted its own GMP Guide, which - in terms of GMP requirements PIC/S GMP Guide (Part II: Basic Requirements for Active PharmaceuticalEudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good Part II - Basic Requirements for Active Substances used as Starting Materials Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which C.5 EU GMP Guide Part II: Basic Requirements for Active Substances used as Starting Materials 11.3 Validation of Analytical Procedures – see Section 12. 2. Aim of the study. I.) Comparison of the EU and WHO GMP guidelines. • to work out guidelines. •. TRS 961, Annex 3 (“WHO good manufacturing practices for Chapter 17, Point 17.1, 17.3 (“Good Practices in quality control”) . Page 12 22 Oct 2015 EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP EU GMP guide annexes: Supplementary requirements: Annex 1: Manufacture of sterile medicinal products 4:12:37 PM]. EU 1 Jan 2017 11.3 Validation of Analytical Procedures - see Section 12. .. annexes to the GMP Guide, in particular Annexes 2 to 7 where supplementary.