Pics guidelines 2017

 

 

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What are your views on ATMP guidance applying to the manufacture of ATMP As ATMP's materials are not covered by the ICH Q7 Guide, the EU GMP Part II or In January, 2017, a new version of the PIC/S GMP (good manufacturing practices) Guide went into effect for use by pharmaceutical manufacturing sites. 1 January 2017. PE 009-13 (Part I). 1 January 2017. GUIDE TO GOOD MANUFACTURING. PRACTICE FOR MEDICINAL PRODUCTS. PART I. © PIC/S January 2017. EU GMP guide part I: Basic requirements for medicinal products: Chapter 1: Pharmaceutical quality system (New July 2018); EU GMP guide H+V February 2017.The TGA has adopted version PE009-14 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP), excluding Annexes 4, In January, 2017, this version of the PIC/S GMP (good manufacturing practices) Guide went into effect for use by pharmaceutical manufacturing sites.

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