How to Implement Changing Regulations in Your Own Factory? A Practical Guide for Response.
Book Title: Practical Compliance with the Latest GMP and Related ICH Guidelines －－－－－－－－－－－－－－－－－－－－－ ★ Thorough and comprehensive explanation of the key points of the revised GMP, including data integrity, risk management, PQS, and supply chain management! ★ Requirements and countermeasures for related guidelines such as ICH Q3C, Q3D, M7 (Impurity GL), and Q13 (Continuous Manufacturing GL)! －－－－－－－－－－－－－－－－－－－－－ ■ Breakdown of GMP requirements in response to changing regulations and ongoing transformations in digital technology! 【1】 Requirements for building a Quality System (PQS) and specific countermeasures 【2】 GMP documentation and its creation and management 【3】 Quality assurance and audits in line with PQS 【4】 Response to Data Integrity (DI) 【5】 Prevention of cross-contamination 【6】 Impurity regulations and required management strategies 【7】 Promotion of DX in pharmaceutical factories and responses to GMP and DI 【8】 Management strategies for continuous manufacturing, GMP compliance, and implementation examples
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■ Table of Contents Chapter 1: Requirements for Building a Quality System (PQS) and Specific Response Methods Chapter 2: GMP Documents and Creation/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/Process Development for Continuous Production －－－－－－－－－－－－－－－－－－－－－ ●Publication Date: September 30, 2024 ●Format: A4, 667 pages ●Authors: 66 individuals ●ISBN: 978-4-86798-041-5 －－－－－－－－－－－－－－－－－－－－－
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