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Books + eBook version: Prevention of GMP Nonconformities for Active Pharmaceutical Ingredients (API) and PIC/S

Inspection of Active Pharmaceutical Ingredient (API) Facilities (PI 030-1)

【Book + eBook】 For details and applications for this product, please check our website. https://www.science-t.com/ebook/22452.html ～What PIC/S inspectors noted during the joint workshop with PDA regarding API GMP inspections～ ～We will convey the insights of European (EMA) inspectors, who are said to have limited information, through "live" comments～ 【This book has been officially authorized by PIC/S for translation and publication】 What is AIDE MEMOIRE… It is a manual created to assist inspectors from PIC/S member countries during GMP inspections. At the joint workshop held in May 2012 in Geneva, Switzerland, between European PDA and inspectors from PIC/S member countries, numerous comments and recommendations were made by inspectors from EU countries regarding issues related to API inspections! The author, who is well-versed in inspections in the three regions, has included respective countermeasures alongside the translation of "API Facility Inspection (PI 030-1)"!