Pharmaceutical Production Validation Guide

Author: National Food and Drug Administration
Publisher:
Publish Date: 2003-08-28
Features: This book is rich in content, not only introducing the basic theory and methods of GMP validation but also emphasizing the specific validation processes through numerous practical examples. It is highly operational and provides valuable references and guidance for pharmaceutical manufacturers in organizing and implementing validation work. It is also an excellent practical reference for engineering and technical personnel engaged in pharmaceutical research and development, production management, pharmaceutical factory planning and design, and pharmaceutical equipment design and manufacturing, as well as for those involved in GMP training and education. This book was compiled by experts and engineering and technical personnel from selected state-owned or joint venture pharmaceutical enterprises in China, organized by the Drug Safety Supervision Department of the National Food and Drug Administration and the Drug Certification Management Center, based on their practical experience in conducting GMP validation in their respective enterprises. The book is divided into six parts and 34 chapters: Part I General Principles, introducing the basic concepts and implementation processes of validation; Part II Validation of Facilities and Equipment, detailing the validation methods for pharmaceutical production environments, water systems, utility systems, and pharmaceutical equipment; Part III Testing Methods, Cleaning Validation, and Sterility Assurance; Part IV Validation of Formulation Production, providing detailed chapters on the validation processes and methods for various dosage forms; Part V Validation of Active Pharmaceutical Ingredient Production; and Part VI Computer System Validation Management.