Container integrity is discussed in ICH Q8, (adopted for human medicinal products only, nevertheless the same principles are also applicable to veterinary medicinal products and containers of sterile substances and containers). 容器完整性在ICH Q8里进行了讨论(正式采纳仅适用于人用药品,但是相同的原则还是...
nevertheless the same principles are also applicable to veterinary medicinal products and containers of sterile substances and containers). 在ICH Q8 中讨论了容器完整性,(仅用于人用药,但同样的原则也适用于兽药产品与无菌 物质的容器)。 2. Scope 范围 The guideline applies to chemical and biological...
Manufacturing of sterile medicinal products The conditions and physical parameters for the following processes are described in detail: Steam sterilisation Dry heat sterilisation Ionisation radiation sterilisation (here reference is made to the Note for Guidance “The use of Radiation in the Manufacture for...
Committee for Medicinal Products for Human use (CHMP) Committee for Medicinal Products for Veterinary use (CVMP)Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container 药品、活性物质、辅料和内包材的灭菌指南 This guideline replaces the document Decision...
GMP Guide: Annex 1 (Manufacture of SterileMedicinal Products)GMP指南:附录1(无菌药品生产) GMP Guide: Annex 11 (Computerised Systems)GMP指南:附录11(计算机化系统) Action: Specialised input(职责:提出专家意见) Guideline on the manufacture of thefinished ...
European Pharmacopoeia general chapter 5.1.2 ‘Biological indicators and related microbial preparations used in the manufacture of sterile products’; NfG on The use of Ionisation Radiation in the Manufacture of Medicinal products 3AQ4A; EN/ISO 11137, Sterilisation of health care products – Radiation;...
medicinal products for human and veterinary use. The general principles also apply to active substances. 本文件意在提供关于人用和兽用化学药品制剂的申报时所需提交的工艺验证资料和数据的 指南。一般原则也适用于活性物质。 However, information on validation of non-sterile active substances is not required...
Decision trees for the selection of sterilisation methods (EMEA/CVMP/065/99) which is an annex to the note for guidance: Development pharmaceutics for veterinary medicinal products (EMEA/CVMP/315/98). 本指南取代了灭菌方法选择的决策树文件(CPMP / QWP / 054/98 ),该文件是药品研发指 南说明(CPMP...
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Switchboard: (+44-171) 418 84 00 Fax: (+44-171) 418 84 47EMEA/CVMP/126/95 FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NOTE FOR GUIDANCE:MANUFACTURE OF THE FINISHED DOSAGE FORM FINAL APPROVAL BY THE CVMP DECEMBER 1995 DATE ...
in respect of the meth ods of manufacture and control take account of scientific and technical progre ss and introduce any changes that may be required to enable the medicinal pr oduct to be manufactured and controlled by means of generally accepted scie ntific methods. 这份指南没有对已授权的...