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)"!
Inquire About This Product
basic information
■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
Price range
Delivery Time
Applications/Examples of results
For more details, please visit our company's website.
catalog（1）
Download All Catalogs
Company information
Nowadays, information is accessible to anyone. However, it is also true that there are barriers that cannot be easily overcome, such as social status based on age, industry, government, company, position, personal connections, and geography, when it comes to acquiring what one truly desires. On the other hand, there is also a barrier where valuable information exists but cannot be communicated to those who need it. Our company aims to transcend that "wall" on behalf of everyone and provide information that connects those in need with those who can share it. 1. We provide a platform for those involved in research and technology at companies to exchange information and foster improvements and advancements in science and practical technology. 2. We offer lectures from corporate engineers and practitioners to undergraduate and graduate students in science and engineering, nurturing the next generation of young talent. 3. We provide children with books that showcase the excitement of science, technology, and the lives and work of those involved in these fields, broadening their future dreams.
![[Data] Classification of Non-Water-Soluble Cutting Oils as Hazardous Materials / Apiste](https://image.mono.ipros.com/public/product/image/f26/2000645264/IPROS02613700727502226673.jpeg?w=280&h=280)
![[Information] Differences between JWNET and e-Manifest](https://image.mono.ipros.com/public/product/image/f11/2001486386/IPROS15773240856844668548.jpeg?w=280&h=280)
