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)"!
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■Author Nobuo Tateishi, Chugai Pharmaceutical Co., Ltd. ■Table of Contents Introduction 【Translation】 Inspection of Active Pharmaceutical Ingredient (API) Facilities (PI 030-1) 1. History 2. Introduction 3. Purpose 4. Scope 5. AIDE-MEMOIRE 6. Revision History 【Commentary】 Chapter 1 Preparation for API Inspection Chapter 2 Quality Management System Chapter 3 Personnel Chapter 4 Buildings and Facilities Chapter 5 Manufacturing Equipment Chapter 6 Documents and Records Chapter 7 Raw Material Management Chapter 8 Manufacturing and In-Process Control Chapter 9 Packaging and Labeling of APIs and Intermediates Chapter 10 Storage and Distribution Chapter 11 Management of Testing Laboratories Chapter 12 Validation Chapter 13 Change Control Chapter 14 Rejection and Reuse of Raw Materials Chapter 15 Complaints and Recalls Chapter 16 Contract Manufacturing (including Testing Contracts) (Refer to GMP PE 009) Chapter 17 Agents, Brokers, Traders, Wholesalers, Repackagers, and Relabelers Chapter 18 APIs Manufactured by Cell Culture/Fermentation Chapter 19 APIs Used in Clinical Trials
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