I. Regulatory Agency Governance (15 Questions) （即监管机构治理(15问题)）.pdf

CPGP Body of Knowledge – 2008 ASQ CERTIFIED PHARMACEUTICAL GMP PROFESSIONAL (CPGP) BODY OF KNOWLEDGE This body of knowledge (BOK) covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, ectoparasitacides, and dietary supplements (alternatively called nutraceuticals) where regulated as drug products, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations. This BOK includes subtext explanations and corresponding cognitive levels for each topic or subtopic. These details will be used by the Examination Development Committee as guidelines for writing test questions and are designed to help candidates prepare for the exam by identifying specific content that can be tested. The subtext is not intended to limit the subject matter or be all-inclusive of what might be covered in an exam but is intended to clarify how topics relate to the role of the Certified Pharmaceutical GMP Professional (CPGP). The descriptor in parentheses at the end of each subtext entry refers to the highest cognitive level at which the topic will be tested. A more complete description of cognitive levels is provided at the end of this document. I. Regulatory Agency Governance (15 Questions) A. Global regulatory framework Identify the acts, statutes, directives, etc., that apply to pharmaceuticals. (Understand) B. Regulations and guidances Interpret frequently used regulations and guidelines/guidances, including those published or administered by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S), Health