[Book] Practical Compliance with the Latest GMP and Related ICH Guidelines (No. 2263)

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 response measures related to ICH Q3C, Q3D, M7, and Q13, among others!
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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/PQS
Chapter 4: Response to Data Integrity (DI)
Chapter 5: Prevention of Cross-Contamination Required by Revised GMP/Domestic and International GMP
Chapter 6: Regulations on Impurities and Required Management Strategies
Chapter 7: Promotion of DX in Pharmaceutical Factories and Response to GMP/DI
Chapter 8: Regulatory Response and Management Strategies/Process Development for Continuous Production
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● Publication Date: September 30, 2024 ● Format: A4 size, 667 pages
● Authors: 66 individuals ● ISBN: 978-4-86798-041-5
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