GMP培训(英文版).ppt

Pharmaceutical Training Seminars, Inc. Pharmaceutical Training Seminars, Inc. Martin L. Jeiven, MS, RPhPresidentJeiven Pharmaceutical Consulting, Inc. A Comparison of EU and US GMPs (We’ve much to learn from those “across the pond”) The Essential Worldwide Principle of GMPs Product Quality depends on: Quality, Safety, and Effectiveness must be designed and built into the product; Quality cannot be tested into the product; and Each step in a manufacturing process must be controlled to maximize the probability that the finished product will meet all its quality and design specifications. Brief GMP History 1957: First GMPs issued as a government regulation (by the Canadian Specifications Board for drug supplied to the Canadian military) 1963/1978: US FDA GMPs 1967: WHO GMPs 1968/1973: UK GMPs 1984: GMPs in more than 25 countries US vs. EU GMPs: Overview In most aspects, both are similar in content and focus on Quality There are a number of important differences There is considerably more detail in the EU GMPs FDA has been criticized for lack of detail in validation, internal audits, the different roles of QA and QC, etc. US vs. EU GMPs: Overview (cont’d) FDA’s response to the criticism: the GMPs are minimum requirements, and industry’s responsibility is to remain current by incorporating into their procedures information from guidances, inspectional guidelines, Warning Letters, FDA presentations, etc. Most countries within the EU update their GMPs every 1-5 years; the US GMPs are substantially the same as the 1978 Final Rule The EU GMPs stress: The expectations of Quality Management and the role of the QP The expectation for, and extensiveness of, validation The need for self-inspection (=internal audits) Training and assessment of competence The role of contract manufacture and analysis EU Countries (2005) International GMP Lexicon ADR Adverse Reaction CA Competent Authority CRO Contract Research Organization CT Clinical Trial CTA Clinical Trial