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Regulatory Agencies 监管机构

Example agencies/organizations  监管机构/组织
FDA (Food & Drug Administration) – USA 美国食品药品管理局
EMeA (European Medicines Agency) – European Union (EU)欧洲药品局
WHO (World Health Organization)世界卫生组织
PIC/S (Pharmaceutical Inspection Cooperation Scheme制药检查合作计划组织 )

Local import requirements 进口要求
Countries only permit the sale of drugs manufactured to their current Good Manufacturing Practices (cGMP)
 各国只允许符合他们国家cGMP要求的产品才可以销售
Location of the manufacturing facility does not matter
 制造工厂的位置没有特别要求
GMP Regulatory Documents 相关文件

Pharmaceutical Manufacturing 药品制造
FDA GMP:  21 CFR Parts 210/211
EU GMP:  EudraLex Volume 4

Aseptic Processing 无菌过程
FDA:  “Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing”
 无菌药品生产行业指南   Sep 2004
EU:  “Annex 1,  Manufacture of Sterile Medicinal Products”
 无菌药品生产  Mar 2009
中国GMP    附录1：无菌药品  (2011/3)
Classification and Monitoring 验证和监测

GMP guidelines (both EU and FDA) require that a cleanroom is classified and then monitored
     GMP指导方针（包括欧盟和美国）要求洁净室需要经过”认证”并且需要”监测”
Classification:   Proving that a cleanroom meets the required ISO standard (ISO 14644-1)
 认证：证明这个洁净室符合ISO标准（ISO 14644-1)
Monitoring:  Continued, ongoing verification that a cleanroom has not shifted from ‘normal’ conditions
 监控：持续证明无菌室没有从“正常”状况下偏离
Classification of a cleanroom洁净室认证

Classification: Certifying that a cleanroom (or clean area) meets a defined class of the ISO 14644-1 standard                                        认证：认证洁净室（或洁净区）符合一个ISO 14644-1标准所定义的等级
Performed every 6 to 12 months (as required in ISO 14644-2)                                   每六个月到1年需做一次（ ISO 14644-2要求）
To a specific procedure…特定流程
Number of sample points (? of floor area, in m2)定义采样点的数量（面积开平方）
Location of sample points (equidistant and work height)定义采样点位置
Volume of air sampled at each point每个采样点的空气采样体积

Verifies that a cleanroom can be used for a certain function                                    确认一个洁净室可以用做特定的生产功能