Guideline for Drug Production Validation (2003)

Author: Drug Safety Supervision Department, National Food and Drug Administration, National Food and Drug Administration
Publisher:
Publish Date: 2003-07-01
Features: This book is compiled by experts and engineering and technical personnel from some state-owned or joint venture pharmaceutical enterprises in China, organized by the Drug Safety Supervision Department and the Drug Certification Management Center of the National Food and Drug Administration, based on the practical experience of these enterprises in carrying out GMP validation. The book is divided into six parts and 34 chapters: Part I General Principles, introducing the basic concepts and implementation process of validation; Part II Validation of Facilities and Equipment, providing detailed chapters on 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, with chapters specifically introducing the validation processes and methods for various dosage forms; Part V Validation of API Production; Part VI Computer System Validation Management. The book is rich in content, not only introducing the basic theory and methods of GMP validation but also emphasizing the presentation of specific validation processes through numerous validation examples, making it highly operational and providing reference and guidance for pharmaceutical manufacturers in organizing and implementing validation work. It is also a valuable reference book for engineering and technical personnel engaged in pharmaceutical research and development, production management, pharmaceutical factory planning and design, pharmaceutical equipment design and manufacturing, as well as for those involved in GMP training and education.