[Book] Practical Compliance with the Latest GMP and Related ICH Guidelines (No. 2263)
TECHNICAL INFOMATION INSTITUTE CO.,LTD
How to Implement Changing Regulations in Your Own Factory? A Practical Guide for Response ★ Thorough and comprehensive explanation of key points of the revised GMP, including data integrity, risk management, PQS, and supply chain management! ★ Requirements and countermeasures related to ICH Q3C, Q3D, M7, Q13, and other relevant GLs! －－－－－－－－－－－－－－－－－－－－－ ■ Table of Contents Chapter 1: Requirements and Specific Response Methods for Building a Quality System (PQS) Chapter 2: GMP Documents and Their Creation and Management in Response to Revised GMP Chapter 3: Quality Assurance and Auditing of Pharmaceuticals in Response to Revised GMP and PQS Chapter 4: Response to Data Integrity (DI) Chapter 5: Prevention of Cross-Contamination Required by Revised GMP and Domestic/International GMP Chapter 6: Regulations on Impurities and Required Management Strategies Chapter 7: Promotion of DX in Pharmaceutical Factories and Response to GMP and DI Chapter 8: Regulatory Response and Management Strategies for Continuous Production and Process Development －－－－－－－－－－－－－－－－－－－－－ ● Publication Date: September 30, 2024 ● Format: A4, 667 pages ● Authors: 66 ● ISBN: 978-4-86798-041-5 －－－－－－－－－－－－－－－－－－－－－
