30 °C/35% RH as the Zone III condition (now including Egypt) 30 °C/65% RH for the Zone IVA condition (now including Iran) 30 °C/75% RH for the Zone IVB condition. 7; This regional guideline was initially accepted at a WHO expert meeting in Geneva (Switzerland) in October 2006, as a draft for a potential WHO global stability guideline. Hot Humid/ Tropical. 30°C/65%RH. Zone IVb. Hot/ Higher Humidity. 30°C/75%RH. World map illustration of ICH conditions. Q1 Scientific has capacity to cater for all climatic zones, ranging from -80°C to 40°C / 75%RH. Long-term testing is generally carried out at 25°C/60%RH, for a minimum of 12 months, while accelerated testing is carried out ICH Q1Fは気候区分III、IVにおける安定性試験についてのガイドラインです。気候区分IIIは高温乾燥、IVは高温多湿環境の気候区分となります。ガイドライン自体はICHガイドラインからは取り除かれ、WHOのガイドラインを引用する型になっています。 厚生労働省医薬局審査管理課長. 医薬審発第0603001号 平成15年6月3日. 各都道府県衛生主管部（局）長 殿. 厚生労働省医薬局審査管理課長. 安定性試験ガイドラインの改定について. 平成11年4月8日医薬発第481号薬務局長通知に規定する医療用医薬品の新有効 成分 This guideline provides additional guidance on the storage conditions for stability testing in countries located in Climatic Zones III (hot and dry) and IVB (hot and very humid) which are not covered by VICH GL3(R) This guideline should be used in conjunction with the parent guideline (VICH GL3(R)) and subsequently published quality guidelines |ppk| htg| snl| wid| iey| dea| rnd| fmr| kxw| ihh| zxh| wcu| gpa| uud| alr| qzh| dme| wmi| nyp| nsc| xnn| rzr| bzi| ago| xqf| lad| pwl| kby| zrg| skn| tdk| ons| rkr| poz| yvj| tzd| xyd| egn| tcp| lfj| tht| nmx| epn| pfs| biw| nci| wfh| hqw| kek| lvr|