质量部分(原料药及制剂)资料的 培训资料.ppt

3.12. Container labelling标签 水泡眼或铝塑板上 Blisters and strips 应包含下列信息 名称，规格，剂型 生产企业名称 批号 有效期 3.13. Product information 药品信息 药品说明书 Summary of product characteristics (SmPC)—供医务人员使用 帮助医务人员及健康从业人员了解药品 多药品说明书的变更应向WHO申报批准 药品使用说明 patient information leaflet (PIL) —供患者使用 相关内容应与SmPC一致 /prequal/WHOPAR/WHOPARGUIDE/WHOPARGuidApplApp3v2_0.pdf Appendix 3 Guidance on Package Leaflet, Summary of Product Characteristics and Labelling  谢谢 ！ Welcome Good morning and welcome to all delegates to this training course offered by the World Health Organization to develop the practical implementation of the WHO GMP text of Good Manufacturing Practice for Pharmaceutical Products. Thanks Our thanks to ______________________ for the arrangements that have been made to accommodate us all for the duration of the programme. Housekeeping (cover fire or emergency procedures, and domestic arrangements including location of toilet facilities, tea or coffee breaks, meal breaks) We shall start by reviewing the programme and introduce our interactive way of working together. We will explain the way the group discussions will work. Modules 1-14 cover the basic principles of GMP. There will be a half-day module on Quality Management and the requirements for a quality assurance unit. You will need to have a clear understanding of the organizational structures that must be in place if a pharmaceutical company is to have the product quality that is required by the National Health Regulator. We shall look at complaint handling procedures and product recall procedures that you should expect pharmaceutical companies to have. This ensures that complaints are properly handled and that patients are protected from dangerous or substandard medicines that have been placed on the market by a proper recall system. This will be followed by a half-day session on Sanitation and Hygiene. Next we will spend a half-day looking at Validation. We then have a half-day module on Contract Production