The Good Manufacturing Practice for Pharmaceutical Excipients was issued on Mar.23, 2006. It is formulated in order to strengthen the quality management of pharmaceutical excipient production and ensure the quality of pharmaceutical excipients, which includes:
Chapter 1 General Provisions
Chapter 2 Institutions, Personnel and Responsibilities
Chapter 3 Plants and Facilities
Chapter 4 Equipment
Chapter 5 Materials
Chapter 6 Hygiene
Chapter 7 Verification
Chapter 8 Documents
Chapter 9 Production Management
Chapter 10 Quality Assurance and Quality Control
Chapter 11 Sales
Chapter 12 Self-examination and improvement
Chapter 13 Supplementary Provisions