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events occur frequently and their effects on the consequences of Conditions II III and IV events should be considered Condition II events may occur during a calendar year for a particular plant Condition III events may occur infrequently during the life of a particular plant



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III and IV defined storage conditions for stability testing in countries located in Climatic Zones III (hot and dry) and IV (hot and humid) i e countries not located in the ICH regions and not covered by ICH Q1 A (R2) Stability Testing for New Drug Substances and Drug Products ICH Q1 F described harmonised global

What is the difference between condition 1 and condition 2?

  • Condition I events occur frequently, and their effects on the consequences of Conditions II, III, and IV events should be considered. Condition II events may occur during a calendar year for a particular plant.

What are condition IV events?

  • Condition IV events are postulated but not expected to occur during the life of a plant. Transient and Accident Analyses 15-2 The SRP divides the events into anticipated operational occurrences (AOOs) and postulated accidents.

Which statement is appropriate for distribution in a zone IV Region?

  • A product with such a statement, received in a zone IV country, would be expected to have demonstrated stability at zone IVa or IVb long-term stability conditions. However, when the stability was demonstrated at zone II long-term conditions, the appropriate statement for distribution in a zone IV region would be “Do not store above 25 °C”.

What if a product has demonstrated stability at Zone II conditions?

  • Demonstrated stability at zone II conditions may result in a label storage statement of “Store between 15 and 30 °C” in line with the convention of some zone II regions. A product with such a statement, received in a zone IV country, would be expected to have demonstrated stability at zone IVa or IVb long-term stability conditions.
[PDF] I - La liste des campings et mobil home : II

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[PDF] I - Le calendrier - École Secondaire

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[PDF] I - LES CHRÉTIENS ONT-ILS FALSIFIÉ LA BIBLE (Coran 2.59) ? Or - Vignobles

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[PDF] i - les staphylocoques a coagulase negative - Rapport Annuel

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[PDF] i - mise en situation ii - cahier des charges iii

[PDF] I - Module et argument d`un nombre complexe II

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