Pharmaceutical cleanroom design, operation, and GMP certification

Author: Xu Zhonglin
Publisher:
Publishing Date: 2002-10-01
Features: With this spirit in mind, the author attempts to compile a book based on his long-term work experience and research findings in GMP, as presented above. This is the book now presented to the readers, titled "Pharmaceutical Cleanroom Design, Operation, and GMP Certification." The book consists of 15 chapters, covering the relationship between GMP and air purification technology, the theoretical and regulatory foundations of pharmaceutical cleanroom design, performance parameters, system equipment, and more. It also discusses different measures for technical renovations of cleanrooms for five types of pharmaceutical dosage forms, as well as operational and maintenance details, and verification and certification practices, all striving to be concise and accessible to a broader audience. The author hopes that if this book reflects the aforementioned spirit and provides assistance to air conditioning and purification personnel, workshop production and management personnel, as well as administrative staff, it will fulfill the author's original intention.