上海CMC培训 GMP and Quality System in the US.pptx

GMP and Quality System in the USJim Li, Ph.D. MBAJune 29, 2010Presentation Overview 21 CFR Part 210 and 211 美国药品GMP法规ICH Q7A ICH的原料药指南CGMP principles CGMP 基本原则Quality systems based GMP approach 基于系统的GMP方法FDA current concepts on process validation 目前FDA对工艺验证方面的观点21 CFR Part 210 and 211 美国药品GMP法规21 CFR Parts 210 and 21121 CFR Parts 210 and 211 GMP Regulations for finished pharmaceuticals: 美国药品生产的GMP法规Establish “what to” do, not “how to” 法规建立了药品生产规范的基本要求, 但未阐明如何做Minimal standardsMaximum flexibilitySpecific enough to address problemsTechnology neutralScalable History of CGMP RegulationCGMP法规的历史和发展History of CGMP RegulationCGMP法规的历史和发展Part 210: CGMP, General 通则210.1 Status of current good manufacturing practice regulationsMinimum CGMP requirements for methods, facilities or controls, manufacture, processing, packing, or holding of a drugFailure renders drug adulterated 伪劣HCT/Ps subject to 1271 in addition to Part 211210.2 Applicability of CGMP regulations.Parts 211-226, 600-680 and 1271 considered to supplement, Applicable to the operations in which he or she is engagedPhase 1 drug exempt from part 211 but subject to U.S.C. 351(a)(2)(B). 210.3 DefinitionsContent of Part 211 内容Subpart A General Provision211.1 Scope211.3 DefinitionsSubpart B Organization and Personnel211.22 Responsibilities of quality control unit211.25 Personnel qualifications211.28 Personnel responsibilities211.34 ConsultantsSubpart C Building and Facilities211.42 Design and construction features211.44 Lighting211.46 Ventilation, air filtration, air heating and cooling211.48 Plumbing211.50 Sewage and refuse211.52 Washing and toilet facilities211.56 Sanitation211.58 MaintenanceSubpart D Equipment211.63 Equipment design, size, and location211.65 Equipment construction211.67 Equipment cleaning and maintenance211.68 Automatic, mechanical, and electronic equipment211.72 FiltersSubpart E Control of Components and Drug Product Containers and Closures211.80 General requirements211.82 Receipt and storage of u