Suchergebnisse
Suchergebnisse:
This document aims to set out uniform statements on storage conditions for inclusion in the labelling of medicinal products and to define when they apply. It is intended as an annex to stability guidelines and relates to marketing authorisations for all product categories.
recommended storage conditions. The choice of test conditions defined in this guideline is based on an analysis of the effects of climatic conditions in the three regions of the EC, Japan and the United States. The mean kinetic temperature in any part of the world can be derived from
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In the course of the discussions which led to the development of the guideline, WHO conducted a survey amongst their member states to find consensus on 30 °C/65% [relative humidity] RH as the long-term storage conditions for hot and humid regions.
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Suitable storage conditions, consistent with those defined in the SPC should be included in the package leaflet and on the product labelling, if appropriate, as stated in Directive 2001/83/EC.
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2. März 2017 · Store frozen: transported within a cold chain and stored at -20°C (4°F). Store at 2°-8°C (36°-46°F): for heat sensitive products that must not be frozen. Cool: Store between 8°-15°C (45°-59°F). Room temperature: Store at 15°-25°C (59°-77°F).
Raising awareness of storage issues during the development of subassemblies, sub-sys-tems and devices is a further consideration. Choosing the correct materials and compo-nents during the design phase is the key to successfully extending the storage capabilities of components and raw materials.
Relevant supporting data include satisfactory long-term data from development batches that are (1) made with a closely related formulation to, (2) manufactured on a smaller scale than, or (3) packaged in a container closure system similar to, that of the primary stability batches.
