EMA: 7 Q&As on In-use Shelf Life of Sterile Products After Opening/Reconstitution
The European Medicines Agency (EMA) has added 7 Q&As to their quality of medicines questions and answers. They refer to EMA‘s 1998 guidance on the shelf-life of sterile products for human use after opening or reconstitution (CPMP/QWP/159/96 corr).
The original guidance emphasised the difficulty of predicting product usage conditions and placed responsibility on users to maintain product quality. The recent Q&As expand on the original guidance, suggesting that in-use shelf life should be supported by stability tests, with companies providing data on product-specific scenarios.
The communication of shelf-life information should adhere to the guidance text, clearly stating in-use storage time and conditions and emphasising user responsibility. The EMA also provides guidance on wording for different product types and a flow chart to assist companies in determining appropriate product information texts for their products.
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