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Subject: Records on the distribution of each batch are maintained. pharm. Control of Manufacture of Bulks and Active Drug SubstancesRelease of bulks or active drug substances to Manufacturing for manufacture of finished products is dependent upon the batch meeting pre-determined QC release specifications. Samples of bulks, active drug substances and some intermediate products are retained and stored under conditions based on stability studies. Records on the distribution of each batch are maintained. Подскажите, пожалуйста, как перевести последнее предложение? |
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