China

Based on the authors’ extensive experience working in China, it became apparent that an English translation of the Chinese GMP would be a very valuable tool for those that needed to compare them with the U.S. GMP that are found in 21 CFR 210 and 211.

This careful translation and relevant documentation will prove to be an invaluable tool for those working with or in China in a variety of healthcare manufacturing capacities. The project was widened to include the GMP for Active Pharmaceutical Ingredients (API) and the English version of the Taiwanese GMP.

Table of Contents:
Chapter 1: Introduction
Chapter 2: Definitions
Chapter 3: The Drug Laws
Chapter 4: Titles, General Matters, and Scope
Chapter 5: Organization and Personnel
Chapter 6: Buildings, Premises, and Facilities
Chapter 7: Equipment
Chapter 8: Materials
Chapter 9: Hygiene and Sanitation
Chapter 10: Validation
Chapter 11: Documentation
Chapter 12: Production
Chapter 13: Quality Systems
Chapter 14: Product Distribution, Recalls, and Returns
Chapter 15: Complaints, Adverse Reactions, Self-Inspection, and Supplemental
Chapter 16: Clinical Trial Material
Chapter 17: The Annexes to the Chinese GMP
Chapter 18: U.S. and ICH Material not included in the Previous Text

Dr. Steven s. Kuwahara, Originally from Hawaii, holds degrees in Biochemistry from Cornell University and the University of Wisconsin. Starting as an Assistant Professor of Chemistry, at the California State University at Long Beach, he began his industrial career in the Division of Biologic Products at the Michigan Department of Public Health (now BioPort Corp.), where he became the head of Quality Control. Here he developed expertise in the testing of blood derivatives and viral and bacterial vaccines. Kuwahara then moved to the Hyland division of Baxter Biotech where he was in charge of assay development and quality control. He later became responsible for quality systems for a biological device. After short stints with a contract testing laboratory and another blood fractionator, he became the director of quality control for a gene and cell therapy company. In recent years, he has worked as the director of assay validations for a large contract testing laboratory and as a GMP consultant to a start-up cell therapy company. His last position was Director of Quality Control and Assay Development for Titan Pharmaceuticals. He currently heads his own firm, GXP BioTechnology, LLC.

Dr. Kuwahara is an experienced analytical biochemist who has applied his academic knowledge to quality control in the pharmaceutical industry. His work also has dealt with all aspects of GMP and GLP in relation to biopharmaceuticals. He has worked with small molecules, proteins, cells, and gene therapy vectors, as well.

Dr. Kuwahara has spoken at numerous industry conferences and has written many papers and book chapters. He serves on the editorial advisory boards of BioPharm, BioQuality, and the Journal of GXP Compliance. He has held certifications as a CQA, CQT, and CQE from the American Society for Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.

Simon Xiuwei Li, MBA, originally from Shanghai, China, holds a bachelor’s degree in Chemical Engineering from Tiangjin University and an MBA degree from the Macau University of Science and Technology. Li began his industrial career with the Shanghai Chemical Reagent Research Institute, first as Assistant Engineer of Applied Chemistry and later as the Assistant Director of the Research Institute. There he developed an expertise in organic synthesis and formulation. He then moved to Johnson & Johnson (China) Co Ltd. to take charge of the production of liquids department. Li later joined the Shanghai Schering-Plough Pharmaceutical Co Ltd. where he was a production manager and senior engineer in organic synthesis. His tenure there was followed by a position with the TSI (China) Company Limited. At TSI, Li started as Operations Director and recently became the Senior Director of Quality and Regulatory.
Mr. Li is experienced in technical operations and quality in the pharmaceutical industry and has written several articles for publication in China.

PDA/DHI Publication